The History and Legacy of Silicone Injections

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Very long - but very, very interesting! - Rogene

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CLEOPATRA'S NEEDLE

THE HISTORY AND LEGACY OF SILICONE INJECTIONS

M. SHARON WEBB, M.D., PH.D.

FOOD AND DRUG LAW

PROF. PETER BARTON Hurr

JANUARY, 1997

CLEOPATRA'S NEEDLE'

THE HISTORY AND LEGACY OF SILICONE INJECTIONS

I. Silicone fluid: the developmental years (1940-1963)

A. What is silicone?

" Scientists and science fiction witers alike have

fantasized that an entire parallel universe could be

built on silicone rather than carbon base. "

--Philip Hilts, 19922

Silicone is not a single chemical. Rather, the

silicones are a family of chemically related

substances all having in common silicon atoms that are

bonded to oxygen and carbon atoms.3 Silicone molecules

have a backbone of silicon attached to carbon; other

organic groups can be bonded to the silicon atom as

well. The basic unit composing all silicones is the

diorganosiloxy group:

R

-0-Si-C-

R

" ~Cleopatra's Needle' is a term used to describe the

silicone injection of breasts in the buxom belles of

Hollywood and Las Vegas. " E. Norling, " Cleopatra's

Needle, " Orange County (Cal.) Bulletin, October, 1968

2 Philip Hilts, " Strange history of silicone held many

warning signs, " New York Times, Jan. 18, 1992.

Silicone, discussed here, must be distinguished from

the atom silicon and the compound silica. The term

" silicone " was coined by Dr. Fredrick Kipping as a

contraction between 'ketone " and " silicon. " Silicon is

an element not found in a pure form in nature. As a

compound with oxygen, silicon comprises 75% of the

earth's crust. Isolating pure silicon from its

compounded form was first performed in 1824, but did

not become commercially practical until the 1930's.

The invention of the semiconductor in the early 1940's

provided additional economic stimulus for producing

silicon more efficiently. (Note that one refers to

Silicon Valley, not SilicQn~..Va1ley when speaking of

the computer industry in the Bay Area.) Silicon bonded

to two oxygen atoms forms the compound silica. Silica

has many commercial uses, including glass, ceramics

and industrial dessicants and binders. In its natural

form, silica is in a crystalline form thought not to

be toxic as a food additive but hazardous when

inhaled. Silicosis and lung cancers result from

respiratory exposure. Amorphous (non-crystalline)

silica lacks the ordered geometry that comprises a

crystal. In its amorphous form, silica is thought to

be much less pathogenic. Of note, amorphous silica is

used as a reinforcing agent in the formation of

silicone plastics for medical uses. See R. LeVier, M.

on, R. Cook, T. Land, ~'What is silicone, "

Plast. Reconstr. Surg. 92: 163, 1993.

The most common organic [R] group is the methyl group

[-CH3], although other groups can be used, often in

combination with methyl groups. Silicones found in

medical applications are thus termed

polydimethylsiloxanes.4 Silicon, with four chemical

valencies, resembles carbon in its versatility.5

Described as a " wonder substance, " silicone could be

turned into products that were " stronger than plastic,

yet more flexible than glass. " 6 A Fortune magazine

story in 1947 devoted eight pages to extolling its

industrial virtues.7

Silicones come in different physical forms, from

watery liquids to solid resins.8 The physical

properties are determined by the length of their

molecular chains and by their degree of crosslinking

or polymerization. The longer the chain, the higher

the viscosity of the substance.9 Silicone gel, like

the filler in breast implants, is a molecular hybrid,

with matrix of long cross-linked molecules and

interstitial filler of silicone oil. Levier et al. in

1993 described the gel used in breast implants as a

" polydimethylsiloxane polymer chemically crosslinked

with vinyl bridges to form a polymer network, and

polymer chain entanglement adds apparent crosslinks.

Cohesive gel is formed when this network is swollen

with 1000 cs viscosity polydimethylsiloxane fluid. " 10

Silicone is made more solid by increasing the length

of the polymer chains and increasing the degree of

cross-linking.

------------------------------------

~ F. , S. Braley, T. Rees, D. Goulian and D.

Ballantyne, " The present status of silicone fluid in

soft tissue augmentation, " Plast. Reconstr. Surg.

39:411, 1967, p. 419. This article also describes how

silicone fluid is produced.

See JY. Cory, " Historical overview and comparison of

silicon with carbon, " pp. 1-56 in S. Patai and Z.

Rappaport, Eds. The Chemistry of Organic Silicon

Compounds (New York: Wiley, 1989).

6 J. A. Byrne, Inf~nn ~ (New York: McGraw-Hill, 1995),

p. 30.

~ " The silicones: cornerstone ofa new industry, "

Fortune 35:104-111, May, 1947

Silly putty represents a failed attempt to produce a

commercially useful silicone rubber.

~ The fluid used for injection under the 1965 IND 2702

had a viscosity of 350 centistokes (with 1 centistoke

[cs] equal to the viscosity of water).

10 Levier et al., " What is silicone, " p. 165, Fig. 1.

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Heat vulcanization and room-temperature (catalytic)

vulcanization are techniques used in the industry to

produce silicone resins and rubbers. The external

shell containing silicone gel for breast implants is

an example of silicone rubber that has undergone room

temperature vulcanization.1'

B. Silicone use in industry

" Polydimethylsiloxane: the grease that helped win the

war. "

-- Warrick, 199012

Despite the association in the public mind between

silicone and cosmetic surgery, the potential medical

uses of this chemical did not motivate its

development. The story of silicone began in the late

1800's, when F.S. Kipping at Nottingham University

introduced a practical method for synthesizing the

carbon-silicon bond.'3 By 1944, he had published 54

papers on the subject pertaining to the chemistry of

the substances that could be made with this type of

bond. Many of his experiments resulted in what he

termed " uninviting glues. " '4 Commercial exploration

had to await the mid-1930's, when Coming Glass Works

hired their first organic chemist, Hyde. Working

for a glass company required Dr. Hyde to have

familiarity with the properties of silicon. When he

encountered the research of Prof. Kipping, he realized

that many of Kipping' s " uninviting glues " could have

useful properties for industrial uses: the silicon

backbone of the molecule provided inertness and heat

stability, while the organic portion of the molecule

would permit

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~' This process is described in F. , S. Braley,

T. Rees, D. Goulian and D. Ballantyne, " The present

status of silicone fluid in soft tissue augmentation, "

Plast. Reconstr. Surg. 39: 411, 1967, p. 4 19-420.

12 E. L. Warrick, Forty Years of Firsts (New York:

McGraw-Hill, 1990), p. 36.

13 Starting the story at this time leaves out earlier

chemists whose contributions made Kipping's work

possible. For an overview of this history, see E. G.

Rochow, Introduction to the Chemistry of Silicones

(Wiley: New York, 1951). The first organosilicon

compound (that is, one with a carbon-silicon bond) was

prepared by Friedel and Crafts in 1863, but the

commercial production of these compounds had to await

the introduction of the Grignard reagent at the turn

of the century.

14 ~• A. Bralcy, " The use of silicones in plastic

surgery: a retrospective view, " Plast. Reconstr. Surg.

51: 280, 1973.

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polymerization. At the same time, R.R. McGregor, a

Corning Glass Research Fellow at the Mellon Institute

in Pittsburgh, began basic research on these

substances.15

By the early 1940's, these research efforts yielded

information about industrial applications for silicone

materials. Coming Glass had originally been looking

into silicone to provide caulking material for their

glass brick products that were popular in the

1930~s.16 Though not a good substitute for mortar,

silicone was observed to have rubber-like properties

that inspired further research during the rubber

shortages in World War II. At the request of Admiral

Rickover, Hyde collaborated with Earl Warrick to

produce the first polydimethylsiloxane fluid in

1940.17 However, the small quantities produced by

Corning Glass did not satisfy the military's

requirements. Since the synthesis of silicones was a

matter of organic chemistry rather than glass-making,

Corning Glass sought the assistance of Dow Chemical in

further product development. Their collaboration

resulted in the formation of the corporate joint

venture, Dow Coming, in 1943.18 Early products

included silicone fluid for dampening vibrations in

Air Force instruments, non-melting grease for

insulating military spark plugs, antifoaming agent

that prevented bubbles from forming in motor oil at

high altitudes, and high-temperature resistent rubbers

to dampen vibrations in cooling fins of aircraft

motors.19 One of the first products to reach wide

usage was a silicone liquid used to insulate electrial

transformers. By the end of World War II, silicone was

used for this purpose wherever the US employed

electrical transformers.20

--------------------------------

'~ R.R. McGregor, Silicones and Their Uses (New York:

McGraw-Hill, 1954). 16 Warrick, Forty Years .... p.

9-10.

'~ Ibid., p. 26.

~' Details about the formation of this joint venture

are presented in Warrick, EQ~yY~Li.~~. pp. 43 ff.

'~ Braley, " The use of silicones..., " p. 281. Also see

Warrick, Forty Years .... p. 36.

20 P.J. Hilts, " Strange history of silicone ... " ;

also J. Foreman, " Women and silicone: a history of

risk , " Boston Globe, January 19, 1992, Sunday, City

Edition.

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C. Early medical uses for silicone

" Since the silicones are relatively new, having been

in existence only for the past 20 years, there is much

uncertainty and lack of knowledge in the profession

relative to them "

-- Blocksma and Braley, 196521

At the end of World War II, when the military

contracts expired, silicone was a product without a

market.22 McGregor and his colleagues at Dow-Coming

therefore investigated various commercial uses,

including furniture polish, high temperature paints,

insulation, caulking and waterproofing.23 Medical

applications for silicone were also developed, both

orthodox and unorthodox. One notable use became

evident when American Army quartermasters noticed

drums of transformer insulating fluid began

disappearing from the docks of Yokahama Harbor in

Japan. This material was injected into the breasts of

Asian prostitutes who sought a more " Western

appearance " to cater to the American servicemen.24 The

popularity of these techniques spread throughout

eastern Asia as silicone injections in the breast were

thought to avoid the known perils of other

techniques.25

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20 R. Blocksma and S. Braley, " The silicones in

plastic surgery, " Plast. Reconstr. Surg. 35:366, 1965.

22 Warrick, Forty Years .... p. 86 ff.

23 McGregor, The Silicones

24 Hilts, ibid., and Foreman, ibid. Their reports

correspond with the history told me by my father, a

medical officer in Japan at that time, who knew

personally an anny master sergeant who administered

breast injections to local women for a fee. The

sergeant apparently obtained the syringes illicitly

from the military medical facilities and used what my

father described as " cooling fluid " readily available

on the base. This behavior did not bring about any

official censure. My father did not know the chemical

make-up of the cooling fluid. (Personal communication,

R. Webb, M.D., 1990) Even if the fluid were

not silicone, this history suggests that the technique

of breast injection with military chemicals was

familiar to some army personnel of that time.

Complications from some of these other techniques,

such as paraffin injections and petrolatum (Vaseline)

injections, were described by one author as

" hair-raising. " F. Ortiz-Monasterio and I. Trigos,

" Management of patients with complications from

injections of foreign materials into the breasts, "

Plast. Reconstr. Surg. 50:42, 1972.

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In addition to this illicit use of industrial

silicone, a variety of innovative therapeutic uses

were investigated for this product. Since silicone

could be applied to glass to prevent liquids from

adhering, the substance was used to coat penicillin

bottles and blood-handling glassware.26 Silicone

rubber was used to form an artificial urethra

implanted in a patient whose own tissues had been

destroyed by venereal disease; this device was

successful at 14 months follow-up.27 Silicone sponges

were used to fill thoracic cavities left after

surgical treatment of pulmonary tuberculosis, with

minimal local reaction.28 When a surgeon at the

University of Michigan sought to develop an artificial

bile duct, Dow fabricated its first silicone rubber

for medical use, Silastic~ S-9711 and its extrudable

counterpart, Silastic~ S~2OOO.29 In 1955, the first

succesful shunt was placed to drain excess

cerebrospinal fluid into the heart in pediatric

hydrocephalus.30

Plastic surgeons were also realizing the potential of

silicone products. Dr. Barrett Brown first

became aware of these substaces in 1947. Although the

use of silicone for burn patients was Brown's initial

concern, he also noted that the substance could help

solve the age-old problem of soft tissue

supplementation.3' Restoring contour to parts of

---------------------------------

26 L. Jaques, E. Fidlar, E. Feldstein, A. Mac,

" Silicones and blood coagulation, " Canad. Med. Assoc.

J. 55:26, 1946.

27 R. De Nicola, " Permanent artificial (silicone)

urethra, " J. Urol. 63:168, 1950. Silicone rubber is

commonly used for urological products such as

catheters to the present day.

2~ J. Gale, A. Curreri, W. Young, H. Dickie, " Plastic

sponge prosthesis following resection in pulmonary

tuberculosis, " J. Thorac. Surg. 24:587, 1952. See also

J. Frindlay and 0. Clagett, " A plastic sponge

prosthesis for use after pneumonectomy: a preliminary

report of an experimental study, " Mayo Clin. Proc.

24: 538, 1949.

29 Braley, " Silicones ..., " p. 282. The surgeon, Dr.

Murray, was unable to produce a leak-proof

anastomosis between the artificial material and the

living tissue, so the artificial bile duct experiment

failed.

30 The shunt was devised by Holter, an engineer

whose baby was born with hydrocephalus. Holter had

invented a stainless steel valve that could be

connected to tubing allowing one-way drainage of

cerebrospinal fluid into the heart. He contacted Dow

Corning for the requisite tubing. Warrick states that

over the next 10 years, over 600,000 such shunts,

using Silasticml tubing had been implanted. See

Warrick, Forty Years..., p. 185.

31 j~ Barrett Brown, M. Fryer, P. Randall, M. Lu,

" Silicones in plastic surgery: laboratoy and clinical

investigations, a preliminary report, " Plast.

Reconstr, Surg. 12: 374, 1953.

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the body that had been damaged or congenitally

deformed was, then as now, a fundamental part of

plastic surgery. Lack of a good substitute for missing

tissue had bedeviled both cosmetic and reconstructive

practitioners from the earliest times, especially when

a large volume of filler was necessary. Skin grafting

was well-established for resurfacing a denuded area,

but filling out a contour defect posed a more

difficult problem. Potential applications for

alloplastic materials envisioned by surgical

innovators seemed tailor-made for various silicone

products. Hard silicone plastic could be used in

cosmetic surgery to augment cheeks, chins and noses.

Rubbery silicone could be used as penile implants,

silicone bags containing silicone gel could enlarge

breasts or replace surgically-removed testicles.

Silicone injections offered particular promise for

small contour deficiencies like scars and wrinkles,

where the placement of the material subcutaneously

would plump out a depressed area.32 Larger doses of

silicone injections were envisioned for major volume

restoration, whether for the breast, the body or the

face.

Brown et al. 's paper anticipated some of these

applications. Though it added little real information

to what was already known about silicone, it was the

first published paper on the subject in the plastic

surgery literature.33 Silicone was considered for

medical use both in its fluid form for injection and

in its rubber or hard resin form. At about the same

time, Scales published his criteria for the ideal soft

tissue substitute.34 The apparent conformity of

silicone with these criteria was apparent to plastic

surgeons and Dow alike.

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32 E. Wegener, " The problem of correction of forehead

wrinkles, " Med. Kosmetik., 5:136, 1957.

'~ Only fairly recently, though, has there been a

generally accessible plastic surgery literature in the

United States. Plastic and Reconstructive Surgery, the

leading journal in the field, was founded in 1946. The

American Board of Plastic Surgery was established in

1937. Much of the innovation in the field betweenthe

World Wars took place in Europe, both in Britain and

on the Continent. See J. McCarthy, " Introduction to

plastic surgery, " pp. 1-24 in J. McCarthy, Ed. Pl~ij

~ry.. V. I (Philadelphia: W.B. Saunders Co., 1990) for

a historic overview of the specialty. It is likely

that the political unrest in the late 1930's in Europe

and the economic distress in the United States had an

impact upon the development of the specialty as a

cohesive field with a well-established scientific

methodology.

'~' J.T. Scales. " Discourse on metals and synthetic

materials in relation to soft tissues; tissue reaction

to synthetic materials, " Proc. Roy. Soc. Med., 46:647,

1953.

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Silicone was considered, in keeping with Scales'

criteria, to be 1) not physically modified by soft

tissue, 2) chemically inert, 3) not inducing

inflammation or foreign body reaction,

4)noncarcinogenic, 5) producing no allergy or

hypersensitivity, 6) capable of resisting mechanical

strains, 7)capable of fabrication in the form desired

and 8) sterilizable. " Despite these appealing

characteristics, the plastic surgery literature

contains only a few reports of research on silicone

materials during the years following Barrett-Brown et

al.'s paper.36

Toxicological research was being conducted

independently, without reference to specific clinical

uses for silicone. The first studies on silicone

fluids in animals determined that the substances had

low toxicity even at high doses.37 These same studies

quoted in a clinical article were said to demonstrate

that silicone is " practically inert physiologically

and non-toxic to body tissues. " 38 Oral aministration

failed to cause discernible effects.39 Though all

research at the time agreed that silicone fluid was

non-toxic whether ingested orally, or injected

subcutaneously, intraperitoneally or intravascularly,

there was evidence after administration by the

intraperitoneal or intravascular routes that the

substance was found in tissues distant from the site

of administration.40 Local reactions to silicone were

evaluated in the same studies. Inflammatory reactions

were described to different extents, depending upon

the dose and route of silicone administration.

---------------------------------------------

~ R. Blocksma and S. Braley, " The silicones in plastic

surgery, " Plast. Reconstr. Surg. 35:366, 1965.

36 I have not been able to identify a historic reason

for this dearth of published research.

~ V. K. Rowe, H. Spencer and S. Bass, " Toxicological

studies on certain commercial silicones and

hydrolyzable silane intermediates, " J. Industrial

Hygeine and Toxicology, 30: 332, 1948.

~ R. Barondes, W. Judge, C. Towne and M. Baxter, " The

silicones in medicine: new organic derivatives and

some of their unique properties, " Mil. Surgeon

106:379, 1950.

~ V. K. Rowe, H. Spencer, S. Bass, " Toxicological

studies on certain commercial silicones II. Two year

dietary feeding of " DC Antifoam A " to rats, " Arch.

Industr Hyg. 1:539, 1950.

~e Rowe et al., " Toxicological studies ... [i and

II] " .; Barondes et al., ibid; S. Kern and R. ,

" Observations on the toxicity of methyl-silicone, " J.

Am. Pharm. Association 38:575, 1949.

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Silicone fluid was known to produce different

reactions than silicone rubber, but in both cases

local reactions were deemed slight.41

These studies were flawed from the perspective of

modern research: the data were poorly tabulated, the

fate of each animal could not be followed throughout

the protocol, and the length of follow-up was

inadequate for determination of anything but acute or

subacute toxicity. Though Dow Corning claimed to have

carried out life-cycle observations in 245 animals

over 12 years by 1960, Brown, et al. commented that

this data was inadequate.42 Despite the limitations of

this research, clinicians relied on it uncritically

well into the 1960's.

In part, these limitations bespeak the corporate

culture at Dow Corning in the 1950's. Its major focus

was on industrial uses for silicone products, with

medical applications considered an insignificant part.

In these early years of product development, Dow

Coming had neither the research interest nor the

facilities to carry out what we today would consider

appropriate testing for medical products. A more

free-wheeling attitude prevailed. Simon Braley, a

personable chemist at Dow-Corning who became

intimately involved in the promotion of biological

applications for silicone43, described without

apparent misgiving the response of Dow to medical

innovators who sought information about the product:

Since our knowledge of the physiological responses of

the silicones at that time was limited ... and because

our medical training was so scanty as to make most of

the questions incomprehensible to us, we found

ourselves at a loss... However, since the silicone

industry had for years manufactured materials that

were looking for applications, and because our

scientific curiosity was piqued, we endeavored to

answer as best we could -- although our answer was

usually some variant of " I don't know, doctor. Here is

a sample. Try it in your animals and see what

happens. "

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41 F. Marzoni, S. Upchurch, C. Lambert, " An

experimental study of silicone as a soft tissue

substitute, " Plast. Reconstr. Surg. 24:600, 1959.

42 J. B. Brown, M. Fryer and D. Ohlwiler, " Studies and

use of synthetic materials such as silicone and teflon

as subcutaneous prostheses, " Plast. Reconstr. Surg.

26:263, 1960.

'~ Silas Braley is described at some length in Byrne,

Informed Consent, p.139 ff.

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D. Silicone injections and the breast

Silicone injections were one of the first successful

Japanese exports into America. "

-- J. Byrne, l995~~

The quest for ideal soft tissue replacement or

supplement has for decades focused on the female

breast. Soft tissue inadequacy (small or ptotic

breasts) has led to women seeking both natural and

artificial means of breast augmentation. Manirnaplasty

procedures, eulogized by surgeons, have not always

produced the same degree of enthusiasm among patients.

Silicone breast implants have been decried by Esther

Rome as a " great experiment upon women. " 47 Prior to

the development of silicone breast implants, however,

other experiments with alloplastic materials were

conducted whose outcomes were so dismal that silicone

gel implants were viewed as a marked advance in

women's health. " Among these experiments was the

injection of silicone fluid.

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" Braley, " Silicones ..., " p. 282.

~ Byrne, Informed Consent, p. 41.

46 See, for example, J. Lalardrie and R. Mouly,

" History of mammaplasty, " Aesth. Plast. Surg

2:167-176,

1978, for a particularly poetic rhapsody about

cosmetic breast surgery.

~ Quoted in P. Corrigan, " Breast implants ... FDA

order sparks debate on safety, " St. Louis

Post-Dispatch, June 2, 1991, p. lA.

~ The Ivalon (polyvinyl alcohol) sponge, devised in

1949, is described in W. Pangman an R. Wallace, " The

use of plastic prosthesis in breast plastic an other

soft tissue surgery, " West. J. Surg. 65:503, 1955; the

Polistan (polyethylene) sponge, formulated in 1950,

was described in Z. Neuman, " The use of the

non-absorbable polyethelene sponge 'polystan sponge'

as a subcutaneous prosthesis, " Br. J. Plast. Surg

9:195, 1957; Etheron (polymethene), introduced in

1960, was reported in P. Regnault, " One hundred cases

of retromammary implantation of etheron, followed up

for thirty months, " Transactions of the Third

International Congress of Plastic and Reconstructive

Surgery (Amsterdam: Excerpta Medica, 1964), pp. 78-

80.

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Earliest use of silicone fluid for breast augmentation

remains undocumented in the Western medical

literature.49 This may reflect the fact that these

procedures were not being performed under medical

supervision, so might not at first have been the

subject of clinical observation. American physicians

became aware of the technique as Asian patients

arrived in the United States in the 1950's. Still, the

use of silicone for breast augmentation remained a

" black-market " type of procedure, carried out by

cosmeticians or injection specialists to cater to the

demands of women in the entertainment industry.50 The

source of this fluid was the only commercal producer,

Dow Corning. During this time period, though, the

company had not directed any of its research efforts

towards developing a purified silicone oil strictly

for medical purposes.51 Even with the establishment of

the Dow Center for Aid to Medical Research in 1959,

purification of Dow Corning 200 fluid was not

undertaken. Silicone injections in the 1950's and

early 1960's still involved transformer fluid.

The procedure began to attain some notoriety by the

early 1960's. A doctor in Las Vegas was quoted in a

1963 Newsweek article as having injected 200 women

with a total of 16,000 doses of silicone.52 Carol Doda

in 1964 transformed herself from a 38-C to a 40-DD

through a series of silicone injections, assuring her

place in history as an icon in topless dancing. As the

procedure gained popularity, reports of complications

emerged,

------------------------------------------

~ Even in the Japanese literature, the first report of

silicone injections in a plastic surgery journal was

not published until 1961. J. Uchida, " Clinical

applications of cross-linked dimethylpolysiloxane;

restoration of breast, cheeks, atrophy of infantile

paralysis, funnel-shaped chest, etc., " Jap. J. Plast.

Reconstr. Surg.

4:303, 1961.

~ Foreman. " Women and silicone

~' Warrick, Forty Years .... p. 169 ff.

32 Newsweek, " Escalation, " 10/25/63, p.1 10. Norman

, in his 12/18/90 testimony, described some

50,000 women in the U.S. who had been injected with

silicone. Cf. Hearings before the Human Resources and

Intergovernmental Relations Subcommittee of the

Comittee on Government Operations, December 18, 1990,

p. 30.

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first episodically and then more systematically.53 In

the 1960's, for example, a 40 year-old woman died

after breast injections when some of the silicone

fluid traveled to her lungs.54 A Ms. Magazine article

described a woman's experiences with breast injections

as a teenager in the 1960's, a series of procedures

that ultimately left both breasts painful, lumpy, and

rock-hard, with collapsed nipples and silicone cysts

requiring needle aspiration.55 Clinicians seeing large

numbers of women with silicone injected into their

breasts were reporting similar complications.56

Complications like lump formation, firmness and

tenderness are understandable physiologically when one

considers how the body reacts to silicone injections.

Injected in a relatively pure form, silicone fluid

nonetheless elicits a local inflammatory reaction and

stimulated scar tissue formation as the body

endeavored to wall off the foreign substance. The

silicone oil has the tendency to break up into

progressively smaller droplets following injection,

with each droplet eliciting its own process of scar

tissue formation. This process was described in a case

report where a large volume of silicone fluid had been

injected for breast enlargement:

The histological slides demonstrate vacuoles

previously filled with silicone of diameters varying

in size fom 1/100 of a millimeter to one millimeter,

and the gross inspection of the removed specimen

showed cysts varying in size from 1 millimeter to 20

millimeters. If one estimates the total volume of

silicone injected in this case at 555 cc., and the

majority of its deposit showing a diameter of 1/10 of

a millimeter, one can come to the mathematical

conclusion that the foreign body injected remains in

the tissue in the form of 30 billion small globules.57

--------------------------------------

~ W. Synimers, " Silicone mastitis in topless

waitresses. " Br. Med. J. 3:19, 1968

~ Byrne, Informed Consent. p. 43. He refers to " horror

stories " that " abounded, " p. 42.

~ D. Lamed, " A shot or two or three in the breast, "

Ms. September, 1977, p. 55.

56 See Khoo Boo-Chai, " The complications of

augmentation mammaplasty by silicone injection, " Br.

J. Plast. Surg. 27:28 1, 1968. See also F.

Ortiz-Monasteio and I. Trigos, " Management of patients

with complications from injection of foreign materials

into their breasts, " Plast. Reconstr. Surg. 50:42,

1965.

~ R. Kaden. " Use of silicone oil in cosmetic

dermatology, " Aesth. medizin. 17:217, 1968, translated

from the German.

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Each of these foreign bodies can produce its own

foreign body reaction, a complicated process involving

both scar tissue deposition and cellular response.

Vigorous reactions to foreign bodies form tissue

masses called granulomata, combinations of scar and

cells that work together to isolate and ingest the

foreign matter. Granuloma formation has been

consistently described in response to silicone

injection.58 Certain cells found in the inflammatory

reactions to silicone injections are potentially

immunologically active, while others have the known

ability to migrate to other parts of the body after

having ingested microscopic amounts of silicone.59

As more experience accumulated with silicone

injections, it was observed that the fluid had a

tendency to displace from the breast area where it had

been deposited and migrate to adjacent areas, showing

up as irregular subcutaneous masses.60 To solve this

problem, agents known to create local inflammation

were added to the silicone fluid to incite scarring

around the injection area so that the fluid would be

immobilized in the desired region61 One version of

this formula was popularized by Dr. Sakurai, a

Japanese doctor who moved to Beverly Hills and helped

popularize the technique.62 Dr. Sternberg,

during the discussion of his paper on silicone

injections at the 84th Annual Meeting of the American

Dermatological Association, remarked that the Sakurai

formula had been given to tens of thousands of women

by 1964 for wrinkle eradication and breast

-------------------------------

~ N. Ben-Hur, D. Ballantyne, T. Rees, " Local and

systemic effecs of dimethylpolysiloxane fluid in

mice, " Plast. Reconstr. Surg. 39:423, 1967.

~ J. s, " Cellular behavior in response to

injected silicone fluid: a preliminary report, " Plast.

Reconstr. Surg. 38:581, 1966.

~ T. Sternberg, F. , L. Winer, " Tissue reactions

to injectable silicone liquids, " Hautartz (Berlin)

14:281, 1964.

61 These additives, including vegetable oils and

mineral oils, were described by Dr. Norman ,

Hearings before the Human Resources and

Intergovernmental Relations Subcommittee of the

Comittee on Government Operations, December 18, 1990,

p. 30.

62 This formula, its variants and its local effects

were described in F. Ortiz-Monasteio and I. Trigos,

" Management of patients with complications from

injection of foreign materials into their breasts, "

Plast. Reconstr. Surg. 50:42, 1972.

-13-

------------------------------------

enlargement.63 Dr. Harry Kagan, an osteopath who was

not a board-certified plastic surgeon, claimed

impressive success and minimal complications with his

version of the Sakurai formula.64 He has been

described as an " apostle " of silicone injections.65

Understandably, the adulterants led to problems of

their own. Dow Corning claimed, and many clinicians

believed, that the problems observed after silicone

injections were due to impurities in the injection

fluid itself.66 To obviate the problem of local tissue

reactions, Dow Corning first introduced Medical Fluid

360, and later replaced it with highiy purified

Medical Grade Fluid MDX 44011 for use in clinical

experimentation.67 In their series of 186 patients,

Ortiz-Monasterio and Trigos emphasized the role that

adulterants played in local reactions, concluding that

" there was no satisfactory solution to some of these

problems. " 68

From a contemporary perspective, it seems ironic that

the silicone gel breast prosthesis was viewed as a

startling advance in women's health. The gel-filled

breast implant, though, was initially thought to avoid

the conspicuous problems of silicone fluid injections.

Early series of case reports seemed to corroborate

this impression.69 Even as alternative methods of

breast enlargement became more available and

successful, still a market for silicone injections. An

ethical physician might ask, as did Dr. Norling in

1968,

----------------------------------------

63 Discussion of " Tissue reactions to injected

silicone liquids, " Arch. Derm. 91:177, 1965.

~ H. Kagan, " Sakurai injectable silicone formula, "

Arch. Otolaryngol. 78:663, 1963. 65 Byrne, Informed

Consent. p. 43.

66 R. Blocksma and S. Braley, " The silicones in

plastic surgery, " Plast. Reconstr. Surg. 35:367, 1965.

67 F. McDowell, " Editorial: complications with

silicones -- what grade of silicone? how do we know it

was silicone? " Plast. Reconstr. Surg. 61:892, 1978.

68 Ortiz-Monasterio and Trigos, " Management of

patients... " , p. 46.

69 See, for example, J. , " Experiences with a

large series of Silastic breast implants, " Plast.

Reconstr. Surg. 49:253, 1972. M. McGrath and B.

Burkhardt, " The safety and efficacy of breast implants

for augmentation mammaplastv, " Plast. Reconstr. Surg.

74:550, 1984, offers a bibliographic overview of some

of these studies.

-14-

----------------------------------------

why silicone injections continue to be used for breast

enlargement. He answered his own question: " The fees

for a series of silicone injections into a patient's

breasts are generally greater than those charged ...

for insertion of the ... Silastic Mammary

Prosthesis. " 70

II. Silicone fluid: years of regulation (1963-1976)

A. Silicone becomes a drug

" The use of silicones in medical applications is a

happy example of the medical and

industrialfraternities working together to adopt an

industrial synthetic product to the needs of the

patient. "

-- S. Braley, l973~'

Dow Corning has claimed that it first became aware of

the practices of silicone injection in 1963, when Dr.

Harvey Kagan presented his clinical experiences with

Dow Corning 200 fluid at a plastic surgery meeting.

Kagan described using the non-sterile industrial grade

fluid since 1946 on an experimental basis, and

pronounced his experiments " successful. " 72 He injected

as much as 2 liters into patients as part of his

clinical experimentation, reporting no systemic

reaction or toxicity as a result.73 Other workers were

more cautious: Dr. Tom Cronin, for example, stated

that " [w]e regard injectable fluid silicone as still a

highly experimental technique and we cannot recommend

its use. " 74

--------------------------------------------------

70 E. Norling, " Cleopatra's needle. "

~' S. Braley, " The use of silicones ..., " p. 288.

72 Byrne, Informed Consent, p. 53.

~ H. D. Kagan, " Sakurai injectable silicone formula. "

~ T. Cronin, quoted in L. Winer, T. Sternberg and F.

, " Tissue reactions to injectable silicone

liquids: a report of three cases, " Arch. Derm. 90:588,

1964, p. 593. Note that Dr. Cronin was one of the

originators of silicone gel breast implants, arguably

a competitive product; one could also argue, though,

that concerns about the safety of silicone injections

inspired Dr. Cronin's search for a viable clinical

alternative.

-15-

------------------------------------------

Injection of silicone fluid was a minor concern to Dow

Corning prior to this time, as other medical

applications appeared more promising. Silicone seemed

to be useful, for example, for coating needles,

syringes and other tubes for medication delivery to

prevent loss of pharmacologically active agents

through adsorption. The product available for these

uses was the same material that insulated

transformers: Dow Corning 200 fluid. When this product

was proposed for immersion therapy in burn care, Dow

began to consider purifying the substance for direct

human contact.75 This purified product, Medical Grade

360, was marketed as an alternative to Dow Corning 200

for clinical uses. 76 By 1965, the company and the

plastic surgery profession were insisting: " We cannot

overemphasize: only properly prepared medical grade

silicones should be use for medical applications. " 77

The development of medical grade silicone corresponded

with Dow's awareness that silicone fluid was being

used as a drug. Recognizing the market potential for

specifically medical uses for silicone, Dow Corning

established its Medical Products Division in 1962 and

built a special plant for drug manufacture in

accordance with the Food, Drug and Cosmetic Act (Tit.

21 §360, U.S.C.A.).78 This factory mainly produced

silicone rubber products under the trade name

SilasticTM.

From this point forward, the FDA was involved in the

oversight of Dow Corning's Medical Products Division.

Understandably, then, the company met with " alarm " the

1963

------------------------------------

- F. Gerow et al., " Silicone immersion treatment of

the severely burned patient, " p. 146 in Trans. Third

Internat. Cong. Plast. Reconstr. Surg. (Amsterdam:

Excerpta Medica Foundation, 1964). Dr. Gerow had been

Dr. Cronin's resident in Texas in 1959 where the two

collaborated to produce a silicone gel breast implant.

The initial clinical use of this device was described

by Cronin and Gerow at the same meeting. See T. Cronin

and F. Gerow, " Augmentation mammaplasty: a new

'natural feel' prosthesis, " Trans. Third Internat.

Cong. Plast. Reconstr. Surg. (Amsterdam: Excerpta

Medica, 1964), p. 41. Gerow's initial contact with Dow

Corning was in Feb. 1961, when he visited the company

to discuss with them his and Dr. Cronin's ideas for

breast augmentation. See Braley, " The use of silicones

...., " pp. 284-5.

76 This was noted to be " similar chemically to Dow

Coming 200 fluid but purified. " F. et al., " The

present status ..., " p. 419.

~' Blocksma and Braley, " The silicones ... " p. 368.

Italics in the original.

~ Braley, " The use of silicones ..., " p. 284.

-16-

---------------------------------------

report by Dr. Kagan that he had used Dow Corning 200

Fluid for injections.79 Eager to avoid misuse of the

Medical 360 fluid, the company required purchasers to

sign an affidavit that the material would be used only

for lubrication purposes. The product nonetheless came

to the notice of the FDA. In 1964, the FDA declared

that the Medical 360 fluid would be considered a new

drug that therefore would require formal approval.80

B. Dow Corning prepares for the FDA

" The clinical use of silicone liquids in man [sic]

preceded any responsible and controlled experiments in

animals. "

--, Braley, Rees, Goulian and Ballantyne, 196781

Dow Corning responded to the FDA's classification by

assembling a panel of seven experts to evaluate the

pre-clinical data substantiating the safety and

efficacy of silicone injections.82 Since animal data

was sparse, panel members , Rees and Goulian

conducted studies in their own laboratories, involving

by their description some 1000 animals.83 The results

of the committee's investigation convinced them that

silicone fluid was safe for medical use: " It was the

opinion of this Committee tht the results obtained

prior to the FDA ruling [that silicone fluid was a

drug] indicated their value and that further

-----------------------------------------

~ Byrne, Informed Consent, p. 43.

~ M. Lappe, testimony at Hearings before the Human

Resources and Intergovernmental Relations Subcommittee

of the Comittee on Government Operations, June 11,

1991 (hereinafter " Hearings " ),pp. 52 ff.

81 et al., " The present status ... " op. cit.

82 5~ Braley, " The status of injectable silicone fluid

for soft tissue augmentation, " Plast. Reconstr. Surg.

47:343, 1971.

83 In addition to the references cited in footnotes 38

& 39, the committee relied on Dow Coming data and

other published reports, as well as its own members'

research. See, for example, R.R. McGregor, " Toxicology

of certain silicone fluids, " Bull. Dow Corning Center

2:15, 1960; P. Grasso, L. Golberg and F. Fairweather,

" An injection of silicones in mice, " Lancet 2:96,

1964. See also T. Rees, J. Platt, an D. Ballantyne.

" An investigation of cutaneous response to

dimethylpolysiloxane (silicone liquid) in animals and

humans. A preliminary report. " Plast. Reconstr. Surg.

35:13 1, 1965.

-17-

----------------------------------

investigations should be conducted. " 84 Further, the

committee members perceived a variety of clinical

applications where they deemed the product effective

in treating a variety of contour deficits.85 et

al. had found their experimental work in animals so

encouraging that they treated 11 patients with medical

grade 360 fluid and reported their findings at the

1964 meeting of the American Society of Plastic and

Reconstructive Surgeons.86

Despite the committee's enthusiasm for the product,

problems were apparent in the animal data prior to the

granting of the ND. Methodological flaws in the design

of animal studies compromised the collection of

scientifically valid data. Careful examination of

these papers indicate a lack of information, in

animals or in humans, about the fate of injected

silicone and the body's long-term reaction to it. As

et al. acknowledged, " t has been found that

silicone fluid tends to disappear from the injection

site, especially when large quantities are injected.

Low viscosity fluids may disappear almost entirely. " 87

No one could state with confidence where the fluid

went.

Furthermore, the data that were available raised more

questions about injected silicone's safety than they

answered. Local reactions to silicone injections were

observed histologically: there were inflammatory

changes and granuloma formation.88 Concerns were

raised about potential for soft tissue

carcinogenesis.89 Macrophages, wandering

immunologically competent cells that ingest foreign

substances, were noted to have

-----------------------------------------

~' F. , et al., " The present status ..., " p.

411.

85 These are summarized in F. , et al, " The

present status ..., " ibid. See also F. , T.

Rees,

D. Ballantyne et al., " An injection technique for the

treatment of facial hemiatrophy, " Plast. Reconstr.

Surg. 35:640, 1965.

86 F. , " The present status ..., " ibid. This

clinical use of silicone fluid was illegal.

87 F. et al., " The present status ..., " p. 413.

88 L. Winer, et al., " Tissue reactions ...

89 N. Ben-Hur and Z. Neuman, " Malignant tumor

formation following subcutaneous injection of silicone

fluid in white mice, " Isr. Med. J. 22:15, 1963.

-18-

----------------------------------------

intracellular silicone.90 Macrophages containing

silicone were found regularly in the regional lymph

nodes and reticuloendothelial system.91 Though

published reports did not reach the medical literature

until the mid- 1960's or later, the findings in these

articles emanated from research carried out in the

early part of the decade.92 It is reasonable to

surmise that much of this information was available to

Dow Corning's advisory committee.

As early as 1960, serious questions were also raised

about the reactions of human tissues to injected

silicone. Barrett Brown, an early investigator

in the medical uses of silicone, commented with

co-workers that clinical experience showed loss of

silicone fluid from the tissues, exposure of injected

materials, infection and slippage.93 These authors

found that an " abnormal consistency in relation to

surrounding tissues is to be expected. " 94 Local

reactions such as firmness, tenderness and contour

irregularities were reported in response to silicone

injections. After 10 years of patient use, Edgerton

and Wells described these same problems, and added,

ominously, that " complete removal was impossible. " 95

Local tissue reactions to injected silicone fluid took

on particular significance when the tissue involved

was the breast. The deleterious effects of silicone

injections in the breast were common knowledge among

plastic surgeons in the 1960's. Of particular concern

was the inability to distinguish large foreign body

granulomatous lesions resulting from silicone

injections from breast cancers. Physical examination

could not discriminate

--------------------------------------

~ T. Rees, J. Platt and D. Ballantyne, " An

investigation of cutaneous response to

dimethylpolysiloxane (silicone liquid) in animals and

humans -- a preliminary report, " Plast. Reconstr.

Surg. 35:13 1, 1965.

~' T. Rees, D. Ballantyne, I. Seidman, et al.,

" Visceral response to subcutaneous intraperitoneal

injections of silicone in mice, " Plast. Reconstr.

Surg. 39:402, 1967.

92 See T. Rees, D. Ballantyne and G. Hawthorne,

" Silione fluid research: a follow-up summary, " Plast.

Reconstr. Surg. 46:50, 1970, for an overview.

'~ J. Barrett Brown, M. Fryer and D. Ohlwiler, " Study

and use ....

~ Ibid., p. 271.

~ M. Edgerton and J. Wells, 'indications for and

pitfalls of soft tissue augmentation with liquid

silicone, " Plast. Reconstr. Surg. 58:157, 1976.

-19-

------------------------------------------------

between benign and malignant masses, and mammography

was useless. Breasts injected with silicone were often

full of firm nodules, or firm painful nodules --

either situation one where breast cancer could go

undetected. Treatment of the symptomatic multinodular

injected breast often involved subcutaneous mastectomy

or total mastectomy.96 and co-workers stated

that the use of injectable silicone in the breast was

excluded when the FDA granted permission to begin

limited clinical trials.97

C. Early FDA regulation of silicone fluid

" There are so many pitfalls and challenges that it is

best to remember that the body actually doesn 't

prefer to retain foreign bodies. "

-- J. Barrett-Brown, M. Fryer and D. Ohlwiler98

Based on the work of the committee of experts, in

reviewing and generating the necessary data, Dow

Corning filed its " Notice of Claimed Investigational

Exception for a New Drug " in l965.~~ ND #2707 was

assigned in July of 1965 to permit limited Phase II

trials for silicone injections.100 Seven investigators

were included in the original group. At approximately

the same time, the FDA's attention turned to the

widespread abuse of silicone fluid. In 1964, after

silicone fluid had been designated a " new drug, "

supplies of the product were seized en route to

various practitioners, including Dr. Kagan. Criminal

charges were brought against Dow Corning and against

A. W. , director of the medical products

division for shipping an unapproved drug in interstate

commerce;

---------------------------------------------

96 A series of these patients is presented in R.

Parsons and H. Thering, " Management of the silicone

injected breast, " Plast. Reconstr. Surg. 60:534, 1977.

These problems were recognized much earlier in the

literature, however. See Khoo Boo-Chai, " The

complications of augmentation mammaplasty by silicone

Injection, " Br. J. Plast. Surg. 27:281, 1968. See also

F. Ortis-Monasterio and I. Trigos, op. cit., and R.

Kaden, op. cit.

~' F. , et al., " The present status ..., " op.

cit., p. 415.

~ J. Barrett Brown, M. Fryer and D. Ohlwiler, " Study

and use of synthetic materials such as silicone and

teflon as subcutaneous prostheses, " Plast. Reconstr.

Surg. 26:263, 1960, p. 273.

~ S. Braley, " The status

'~ M. Lappe, testimony at Hearings ..., p. 203.

-20-

-----------------------------------

indictments were obtained in 1967.101 The case was

resolved in 1971 when both defendants pleaded nob

contendere and were fined $5000 and $1000,

respectively.

As concerns about the safety of silicone injections

continued to accumulate in the medical literature, the

FDA suspended ND #2702 in October, 1967, citing

inadequate information about manufacturing and

sterilizing procedures.102 The ND was reinstated in

March of 1969 after review of more extensive data

about good manufacturing practices.'03 Problems with

experimental design persisted, however. In 1975, Dow

Coming filed NDA #17-767 with the FDA only to suspend

the application in March, 1976, because supporting

animal studies and human studies were again considered

inadequate.104 Correspondence between Dow and Margaret

, Acting Director, Division of Surgical-Dental

Drug products, cited the data produced in the IDE

trials: the study, initiated in 1965, was a

non-blinded, single-treatment prospective study

conducted by seven plastic surgeons and one

dermatologist involving 1,333 patients.'05 Of these

patients, 709 were treated by the dermatologist for

such conditions as wrinldes and acne scars. 487 of

these 709 patients did not complete their course of

treatment; only 408 of the dermatologist's patients

were followed sufficiently to allow any data to be

collected. In addition to this deficiency, Dow Corning

recognized that there was a " considerable degree of

treatment variation among the

------------------------------------------

101 Charge by grand jury, E. Dist. Mich. August 16,

1967, on a sixteen count indictment, violating Federal

Food, Drug and Cosmetics Act (Title 21 USC, § 3

10-392) relating to 8 shipment of product designated

Dow Corning Medical Fluid 360. Counts include unlawful

shipment of new drug w/o complying w/statutory

requirements, and shipment of drug which is

misbranded. Nov. 1971 FDA Papers 5:40, November, 1971;

FDA Papers 5:29, May, 1971.

102 " Silicone's new role is not so prominent, " Medical

World News, June 6, 1969, p. 19.

103 This regulatory history was obtained from

testimony during the Hearings before the Human

Resources and Intergovernmental Relations Subcommittee

of the Committee on Government Operations, June 11,

1991.

~ Much of this research is summarized and referenced

in T. Rees et al., " Silicone fluid research

~ Letter dated 5/8/75 from J. Radrius, Food and Drug

Counsel at Dow Corning, to Margaret , M.D.,

regarding IiND 2702.

-21-

--------------------------------------

five physician groupings used in the analysis. " 106

After an exchange of correspondence with the FDA in

1976, Dow Corning withdrew the NDA and deferred their

attempt to gain approval.

III. Silicone fluid: Years of Decline (1976-1992)

A. Public awareness

" ... Celia ... sued her doctor after her face

developed large sores that could not heal because of

the silicone in her tissue. "

-- P. Hilts, 1992107

" It is becoming clear that silicone is not

biologically or chemically inactive "

--T. Sergott et al., 1986108

In the public mind, the tide was turning against

silicone fluid. " Forget about silicone injections, "

Dr. Thosteson advised in his medical column in

the Boston Herald Traveler.109 The Los Angeles Times

wrote at length about an article in the Journal of the

American Medical Association that provided the " first

hard data of adverse systemic effects in humans. " " 0

Awareness was increasing in the general public that

silicone injections could be harmful. Dr. Norling

informed readers of the Orange County Bulletin that

" njected silicone ... has caused two deaths and one

case of temporary blindness. " 11 I In describing the

complications of silicone, he also observes that " [w]e

do not know if the

------------------------------------------

'~ Ibid., p. 4.

107 P. Hilts, " Doctors continue to inject silicone

despite FDA warnings, agency says, " New York Times,

Feb. 2,1992.

108 T. Sergott, J. Limoli, C. Baldwin and D. Laub,

" Human adjuvant disease, possible autoimmune disease

after silicone implantation, " Plast. Reconstr. Surg.

78:104, 1986.

'~ G. Thosteson, " Her figure lacks firmness; silicone

injections not the answer, " Boston Herald Traveler,

Jan. 9,1969.

110 H. , " Silicone injections a health hazard,

study indicates, " Los Angeles Times, Nov. 2, 1975.

E. Norling, " Cleopatra's needle. "

-22-

-------------------------------------------

estimated 20% of silicone which leaves the site of

injection goes to the liver, kidneys, lungs or other

organs. The metabolism of injected silicone and method

of excretion, if any, continues to remain a

mystery. " 112

Political attention became directed toward the

problems resulting from silicone injections. By 1975,

there was sufficient concern in Nevada about the

health risks to entertainers injected with silicone

that a state law was past criminalizing silicone

injections.

Dr. Kopf, a Las Vegas plastic surgeon, was

responsible for bringing the dangers

of silicone injections to the attention of the Nevada

Attorney General. " Thousands of these women started

hollering, " Dr. Kopf recalled, leading him to

undertake his lobbying efforts to get legislation

passed.113 . California and Colorado followed shortly

thereafter. " 4 Doctors were prosecuted for violating

these statutes and criminal convictions resulted. " 5

Successful lawsuits, with causes of actions ranging

from malpractice to fraud, were brought against

doctors who performed silicone injections.116 A charge

of " murder by malpractice " in 1979 was dismissed due

to insufficient evidence: autopsy findings of silicone

in the victim's lungs following breast injection did

not prove proximate causation in the court's

opinion.'17 The autopsy findings in this case bore

striking similarity to those found in a 1973 Georgia

criminal investigation, where silicone fluid was

retrieved at autopsy from the lungs, liver, kidney,

blood and brain of a woman who died of acute

---------------------------------------------

112 Ibid.

113 J~ Foreman, " Women and silicone

" ~ Nev. Rev. Stat. Ann. Tit. 15 @ 202.248 (1995); Cal.

Bus. and Prof. Code Div. 2, Ch. 5, Art. 12 @ 2251

(1996).

" ~ v. Gault, 125 Cal. App. 3d 623 (1981) at 639

(describing the conviction of Dr. Gault for illegal

silicone injections in 1968 under former Cal. Health

and Safety Code section 26288).

116 Short v. Downs, 537 P.2d 754, 1975.

117 Lockhart v. State, Texas Ct. of Crim. Appeals,

Slip op. no. 60,216, Mar. 21, 1979.

-23-

-----------------------------------------

pulmonary edema following silicone fluid breast

injection.118 The senior toxicologist in the Georgia

Crime Lab, June , contacted Dow Corning in 1973

to obtain specimens of Dow 200 fluid, to be compared

to the silicone fluid recovered from the breasts of

the victim.119 A particularly notorious case received

widespread publicity several years later, when a

male-to-female transsexual died as a result of

silicone fluid injections.120

B. Medical awareness

" As far as the future is concerned, we must remember

that these reports will not go away if we ignore or

deny them.

-- T. Sergott, et al., 1986121

As early as 1975, questions were raised in the English

literature about serious systemic consequences of

silicone fluid injection. Ellenbogen et al. described

four patients whose complications included

granulomatous hepatitis and death.'22 The mechanism

postulated for the patient's death was silicone

embolization to the lungs, resulting in acute

pulmonary edema. The silicone fluid injected in the

victim's breasts had made its way into the vascular

system and was distributed to the lungs; a similar

mechanism would account for distribution of the fluid

to the liver, with resulting granulomas and subsequent

hepatitis. Intravascular distribution of injected

silicone was similarly thought to be responsible for

pneumonitis and systemic malaise following breast

injection in a male-to-female

----------------------------------

" ~ E. s and J. , J. Forensic Sciences,

1974, 191-198, " The detennination of

polydimethylsiloxane (silicone oil) in biological

materials: a case report. " This article looked at the

autopsy findings of a woman who died of pulmonary

edema soon after the injection of silicone fluid into

both breasts. At autopsy, silicone fluid was recovered

from lungs, liver, kidney, brain and blood. It was

concluded that the cause of death was pulmonary

insufficiency secondary to a foreign substance,

silicone fluid.

119 Proprietary Dow Corning documents, dated 4/5/73

and 4/9/73.

120 People v. Ellison, 426 N.E.2d 1058, 1981.

121 T. Sergott, J. Limoli, C. Baldwin and D. Laub,

" Human adjuvant disease, possible autoimmune disease

after silicone implantation, " Plast. Reconstr. Surg.

78:104, 1986.

122 R. Ellenbogen, R. Ellenbogen and L. Rubin,

" Injectable fluid silicone therapy: human morbidity

and mortality, " JAMA 234:308, 1975.

-24-

------------------------------------------

transsexual.'23 All these syndromes were initially

considered simple embolic reactions:

foreign material gains access to the bloodstream and

is distributed to organs like the liver and the lung,

where the foreign substance causes local reactions.

Similar reactions in tissues are found when natural

substances like fat or small blood clots gain access

to the microcirculation. These silicone-related

conditions have therefore been analogized to the more

familiar situation of fat embolization. However, a

similar systemic illness with pulmonary manifestations

was reported in a woman following silicone gel breast

implantation.'24 In this case, there was no evidence

for intravascular dissemination of foreign material.

The question of an immunologically mediated mechanism

was posed.

The possibility of an immune response to silicone

injections producing illness was first raised in the

Japanese literature. A 1963 report described a

systemic illnesses resembling human rheumatoid

arthritis following paraffin injections in the

breast.'25 These authors termed the syndrome they

observed " human adjuvant disease, " characterized by

autoimmune-like symptoms, foreign body granulomas and

involvement of regional lymph nodes. This syndrome was

analogized to the immunologically mediated condition

produced in experimental animals by injecting Freund's

adjuvant to induce delayed hypersensitivity.'26

Following the criteria Miyoshi et al. listed, Yoshida

presented seven cases of human adjuvant disease

following silicone or paraffin breast injections.'27

-------------------------------------------

123 J. Chaste, F. Basset, F. Viau, et al., " Acute

pneumonitis after subcutaneous injections of silicone

in transsexual men, " NEJM 308:764, 1983.

124 B. Uretsky, 'Augmentation mammoplasty associated

with a severe systemic illness, " Ann. Plast. Surg.

3:445, 1983.

125 K. Miyoshi, T. Miyamura, Y. Kobayashi, et al.,

" Hypergammaglobulinemia by prolonged adjuvanticity in

man. Disorders developed after augmentation

mammaplasty, " Jpn. Med. J. 2 122:9, 1964.

26 The biology of adjuvant disease is reviewed in Y-H.

Chang, C. Pearson, C. Abe, " Adjuvant polyarthritis, "

Arthritis Rheum. 23:62, 1980. See also Sergott et al.,

" Human adjuvant disease

127 K. Yoshida, " Post mammaplasty disorder as an

adjuvant disease of man, " Shikoku Acta Med. 29:318,

1973.

-25-

--------------------------------------------

In 1979, Kumagat et al. examined the epidemiology of

rheumatological disease among Japanese patients

injected with silicone fluid, concluding that the

association between silicone injections and

rheumatological disorders could not be due to

chance.'28 By 1984, he had identified an additional 46

patients with signs and symptoms of connective tissue

disease following either silicone or paraffin

injection.'29 His report included cases from the

Japanese literature not previously described. Fock et

al. presented additional cases where autoimmune

diseases developed after silicone breast injections;

these authors explicitly posited a causal mechanism

for the syndrome.'30

Concerns about the association between silicone and

connective tissue disease remained predominately in

the province of rheumatology until the early 1980's.

Plastic surgeons, if they addressed the topic at all,

did so with skepticism.'3' After years of questioning

the potential immunological effects of silicone fluid

and gel, Heggers and coworkers published the first

in-depth examination of this topic in the plastic

surgery literature in 1983.132 Their analysis

corresponded to the observations ofF. McDowell several

years earlier:

The total surface area of the foreign body exposed to

the patient's reactive mechanisms would appear to be a

major factor. ... f one gram of silicone gel should

diffuse, molecule by molecule, through the envelope of

a breast prosthesis and settle into the adjacent

breast tissue -- in the form of millions of tiny

globules only a few microns in diameter -- an enormous

surface area

------------------------------------------

129 Y. Kumagai, C. Abe and Y. Shiokawa, " Scleroderma

after cosmetic surgery, " Arthritis Rheum. 22:532,

1979.

129 Y. Kumagai, Y. Shiokawa, T. Medsger and G. Rodnam,

" Clinical spectrum of connective tissue disease after

cosmetic surgery, " Arthritis Rheum. 27:1, 1984.

130 K. Fock, P. Feng, B. Tey, " Autoimmune disease

developing after augmentation mammoplasty: report

of three cases, " J. Rheumatol. 11:98, 1984.

131 C. Baldwin and E. Kaplan, " Silicone-induced human

adjuvant disease? " Ann. Plast. Surg. 10:270,

1983.

132 J~ Heggers, N. Kossovsky. R. Parsons, et al.,

" Biocompatibility of silicone implants. " Ann. Plast.

Surg.ll: 38, 1983.

-26-

---------------------------------------------

would be exposed to the patient's reactive mechanisms.

The above concept fits somewhat with what has been

happening.'33

The accumulation of data surrounding the adverse

effects of silicone injections was, no doubt,

dampening enthusiasm for the product among plastic

surgeons. Though there still appeared to be legitimate

medical uses for silicone fluid, fewer testimonials

appeared in the literature extolling its virtues. More

measured descriptions of its uses were published. For

example, a conclusion that " ... when pure medical

grade fluid is utilized in small, spaced and

controlled doses and in favorable doses and in

favorable deformities located in favorable sites,

complications are rare " appeared in a 1979 plastic

surgery textbook, reflecting a more cautious

attitude.'34 The spectre of connective tissue disease

following silicone injection only merited a passing,

unreferenced, mention in this standard reference work.

C. FDA regulation of silicone fluid

" Silicone injections have been conidered not safe and

effective for twenty years.

-- Rep. Ted Weiss, 1991' "

In its letter to Dow Corning in January, 1976, the FDA

cited some of the problems with the data the company

had submitted in its NDA #17-767 for silicone fluid:

inadequate follow-up, lack of case reports and

numerous patients who left the protocol and failed to

complete trreatment.'36 The company resubmitted an

amended ND (2702) in September, 1977. Approval was

recommended by the Surgical Drugs Advisory Committee

in December, 1977. In March, 1978, the silicone fluid

protocols were approved by the FDA under ND 2702,

despite its observation that inconsistencies still

plagued the supporting

----------------------------------------

133 F. McDowell, " Editorial: complications with

silicones -- what grade of silicone? how do we know it

was silicone? " Plast. Reconstr. Surg. 61:892, 1978, p.

894

" ~ T. Rees et al., " Inorganic implants, " p. 401.

~35 Hearings ..., p. 2.

136 Hearings .... p. 197.

-27-

------------------------------------------

animal studies, so " the drug should not be injected in

clinical situations where the benefit to risk ratio is

below that proposed in the present [clinical]

protocol. " '37 This protocol limited use of the drug to

serious facial deformities, specifically excluding

cosmetic applications. Eight investigators were

involved, the original seven plus an additional

dermatologist, Dr. Norman Orentreich.

Following the passage of the 1976 Medical Device

Amendments to the Food, Drug and Cosmetic Act, the FDA

was charged with identifying certain drugs that would

be reclassified as devices.'38 The FDA announced in

December, 1977, that silicone injections would be

subject to these transitional provisions.'39 In 1979,

Dow's ND for silicone injections was transferred from

the Bureau of Drugs to the Bureau of Devices.'40 Its

protocol was renumbered as IDE L002702.

Under this protocol, patients could be enrolled only

for the treatment of serious facial deformities. The

details of the clinical investigation were published

in the FDA Consumer, March 1979, in an article

entitled " New face lift not all smiles. " '4' There, it

was specified that clinical investigation was

permitted only for conditions like hemifacial atrophy,

facial lipodystrophy, etc., all serious facial

deformities. Complications of the procedure (swelling,

migration, emboli, thrombosis, discoloration, skin

stretching, occasional death) were spelled out.

Between 1979 and 1981, 600 patients were enrolled in

the protocol.

Silicone injections were able to be used under IDE

L002702 while data was collected through the protocol.

The status of all transitional devices was clarified

in 1988:

----------------------------------------

~ Letter dated 3/13/78 from Philip Walters, acting

director, Division of Surgical-Dental Drug Products,

FDA, to A. Rathjen, Dow Corning Corporation.

138 § 520(I)(1) of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. 360j(l)(l).

~ 42 FR 63472 140 45 FR 58964

141 Document inserted in Hearings ...

-28-

------------------------------------------

these would all be classified in Class rn.'42 Silicone

injections, though, received special attention. The

agency ruled in 1988 that " although this device is

classified by statute as a class Jill device, FDA will

not publish a final classification regulation

describing the device's statutory classification into

class III unless the agency approves an application

for premarket approval for this device. " '43 Dow

Corning began to gather its data for submitting a PMA

application. Before the PMA application was submitted,

the FDA requested from the company an interim report.

The information required by this order included an

update on the protocol and a summary of current

information from the scientific literature. Notably,

new literature was sparse to support the safety and

efficacy of silicone injections.'44

Dow Corning filed its report on the silicone injection

protocol with supporting information on August 24,

1990, as requested by the FDA. The submitted material

was deemed unsatisfactory. In his review dated

September 10, 1990, P. Tilton described the

inadequacies of the study material: there was no

follow-up longer than four years on any study patient,

thre were insufficient pre- and post-treatment lab

studies, there were no objective measurements of

improvements and there were not enough " After "

pictures to show the individual patient results.'45

There is no evidence that Dow Corning sought to

correct these deficiencies. Once the supporting

materials had been rejected by the FDA during the

preliminary evaluation, Dow Corning did not elect to

pursue a formal PMA application. When the FDA required

in November, 1991, that all transitional Class III

-------------------------------------------

142 53 FR 23856.

'~'~ Ibid.

In the 1980's, the plastic surgery community turned

its attention increasingly towards silicone breast

implants. The published literature available to Dow

Corning about silicone injections in 1990 was not much

greater than that available in 1979; this literature

has been already referenced in the notes supra.

145 Letter dated Sept. 21, 1990, from P. Tilton to A.

Rathjen, Dow Corning.

-29-

------------------------------------------

devices submit safety and efficacy information within

60 days, Dow Corning did not respond.' "

The company's attention, following the November, 1991

hearings on breast implants, was understandably

directed elsewhere. It is likely that corporate

attention had been focused on breast implants for

several years preceding these hearings.'47 The IDE for

silicone injections therefore became invalid in

January, 1992. This product, so full of promise and

problems, was allowed to retire quietly from clinical

medicine.

D. FDA enforcement

" In no uncertain terms let me say to the medical

community that we will subject not only the

manufacturers, but all those involved in the

manufacturer's promotion, to the fullforce of the law "

--Commissioner Kessler, 1991148

The 1992 report of the Human Affairs and

Intergovernmental Affairs Subcommittee of the House

Government Operations Committee criticized the

inaction of the FDA in regulating silicone

injections.'49 The ambivalence of the agency, the

Subcommitee found, centered around its reluctance to

interfere with the practice of medicine. The

subcommittee report supported this finding by tracing

the history of FDA enforcement of its rulings about

silicone injections.

In a May, 1981, letter, the Associate Director for

Compliance of the FDA recited the statutory authority

of the agency to regulate drugs, and stated that

physicians could not inject silicone for soft tissue

augmentation unless they are participants in an ND

-------------------------------------------

146 56 FR 57960.

147 Some authors point to the 1984 award of $1.5

million in the Stern lawsuit as the beginning of the

breast implant crisis. See S. Lichtenstein, " A

discusion of the silicone gel-filled breast implant

controversy. " Rev. Litig. 12:172, 1992, for an

overview of the early implant lawsuits. Others cite

the 1988 House Subcommittee on Human Resources and

Intergovernmental Relations Hearings, where the

carcinogenicity of breast implants was investigated.

In any case, after the December 1990 Connie Chung

program on breast implants, the high profile of the

issue demanded Dow Corning's constant attentlon.

148 D. Kessler, Hearings ..., quoted in The Gray Sheet

Vol. 18, June 17, 1992.

149 HR. Rep. 102-1064, Nov. 19, 1992, p. 3.

-30-

-----------------------------------------

protocol.'50 Though she recognized that resources were

limited, she supported imposing sanctions on

physicians who broke the law.

During the 1970's and 1980's, the FDA pursued

egregious violators. In 1984, the FDA interviewed Dr.

Aronsohn, a Los Angeles otolaryngologist who

admitted injecting silicone but stated that his use

was legal because he had purchased his supply in 1962

before the substance was regulated by the FDA.'5' The

doctor is reported to have told the FDA investigator

that he could legally inject his patients with mud if

he felt like it; further, since he was not involved

with the Dow Corning study, he did not need to report

his patients' results to anyone.'52 In 1985, Walter

Gundaker, FDA Director of Compliance, Center for

Devices and Radiological Health, suggested that Dr.

be investigated for selling silicone

fluid to physicians; however, the FDA was unable to

" locate, contact or even confirm the existence " of

this person.153

Dr. Norman Orentreich, originally included as an

investigator when ND 2702 was reinstated in 1978, came

under FDA scrutiny during the late 1970's when he

refused to confine his use of injectable silicone to

the serious facial deformities specified in the

protocol. According to the review of the 1976 Dow

Corning ND, he had treated several hundred patients

with liquid silicone for cosmetic purposes without

including them in the research records submitted to

the FDA.'54 Because he failed to conform to the

provisions of the IDE approved in 1978, he was dropped

from the roster of investigators.'55 Still he

maintained a robust cosmetic practice as a

dermatologist in New York City, with

------------------------------------------------

~so Letter from Ann Holt to Glen Dorfman, quoted in

H.R. Rep. 102-1064, p. 3.

'~' Memorandum from FDA District Director, Los Angeles

District, to the Director of the Investigations

Branch, Sept. 12, 1984, quoted in H.R. Rep. 102-1064,

p. 4.

152 Ibid.

153 Memorandum to FDA District Director, Region II,

Brooklyn, N.Y., July 26, 1984.

154 Medical Officer's Review of New Drug Application,

Jan. 12, 1976, p. 4,9.

" ~ HR. Rep. 102-1064, p. 4.

-31-

------------------------------------------

appreciative movie stars as patients.'56 When FDA

officials wamed Dr. Orentreich about his use of

silicone fluid without the requisite PMAJIJ)E, he

challenged the FDA by claiming that since he

manufactured his own silicone (by purchasing

industrial grade silicone legally and then purifying

it with filter and sterilizer), there was no

interstate commerce and thus no FDA jurisdiction. A

New York Times report described Orentreich's response

to the FDA waming: " Who is the FDA? A few technicians

and one or two doctors? " '57

Dr. Orentreich's prosecution may well have been

sidetracked by a FDA memo in 1984 that mentioned that

Reagan was one of his silicone injection

patients.'58 Despite this memo, the FDA's

investigation continued for awhile, resulting a call

for an injunction against Orentreich in 1985; of

special concern to the Walter Gundaker in the local

Office of Compliance was the presence of the same

impurities in his product that were found in

industrial grade silicone. The investigation was

kicked upstairs shortly thereafter:

a memorandum to Gundaker from the FDA headquarters

placed the Orentreich injunction recommendation " in

permanent abeyance. " '59 Grounds for this decision

included the agency's reluctance to single out one

physician when illegal use of liquid silicone was

widespread, and the agency's preference that " practice

of medicine " issues be handled on the state level.

Protected by the " permanent abeyance " decision, Dr.

Orentreich avoided FDA investigation for several

years, while continuing his practices of cosmetic

silicone injections.

Not until 1991 did the FDA pursue action against

physicians performing silicone injections. Anonymous

letters in May of 1991 alerted the agency to the

activities of a dermatologist in Several months after

the FDA was asked about compliance issues at the

------------------------------------------

156 Personal communication, Hutt, former General

Counsel FDA, Cambridge, Mass., Jan. 13, 1997.

~ R. Blumenthal, " New York dermatologist is fighting

with FDA over silicone injections, " New York Times

July 19, 1991.

158 FDA memorandum from Gerstenberg to Marvin

Shumate, quoted in " Hearings ..., " p. 192.

'~ This history is detailed in H.R. Rep. 102-1064, p.

5.

-32-

--------------------------------------------

June, 1991, Subcommittee Hearings on silicone

injections, the agency sent waming letters to Dr.

Orentreich and several other physicians. Two of these

doctors, Aronsohn and Fulton, were

investigated by undercover FDA agents who posed as

patients or as cosmetic surgeons. Along with Dr.

Samitier-Cardet in Miami and Dr.

Kalman in New York, these physicians received notice

from the FDA that their use of silicone liquid was

illegal.'60 The physicians addressed by the FDA were

Dr. Aronsohn, Dr. Fulton.

While Drs. Aronson and Samatier-Cardet initially

claimed that they would continue to inject patients

with liquid silicone, since the FDA had no

jurisdiction over the practice of medicine, they both

later abandoned their position. In his first letter to

the FDA in January, 1992, Aronsohn told the agency the

virtues of cosmetic silicone injections and remarked,

" To my knowledge,the FDA has no legal jurisdiction

over the practice of medicine. " '6' A month later,

Aronson reconsidered his stance; he offered the FDA a

compromise whereby he would stop injecting new

patients, but wanted to complete the work on patients

whose treatments were already underway. This

compromise was unacceptable to the FDA. In May of

1992, a consent decree of permanent injunction was

entered against him, made final later that year.

Similar consent decrees were signed in 1992 by Drs.

Fulton, Orentreich and Kalman.'62

-----------------------------------------------

160 The Gray Sheet 17(49):7-8, December 9, 1991.

161 J~ Foulke, " Two doctors ordered to stop silicone

injections; cosmetic surgery technique, " FDA Consumer

27 (2):27, Mar. 1993.

62 The Gray Sheet 18(44):l0, November 2,1992 and FDA

Consumer 27(2):27, March, 1993.

-33-

---------------------------------------------

Epilogue

A. Legal Issues

" Efforts by he physician community and the FDA caused

a halt to liquid silicone injections into the breast.

No ethical physician would do that today. "

-- Norman , 1990163

With these consent decrees it might seem that what

Philip Hilts has called " the strange history of

silicone " has come to an end. This, though, is far

from the truth. Concerns about silicone fluid are very

much alive today, both for patients who have received

the substance in the past through injections and for

patients whose exposure may be due to their silicone

gel breast implants.

A number of civil cases are currently being litigated

where patients suffered ill-effects from silicone

injections.'64 Many of these injections were illegal,

since the substance was administered outside the FDA

ND or IDE protocols.'65 While systemic illness from

silicone injections is hard to prove, the causal link

between the injection and the local effects is easy to

make. Firm, red, tender knots within and beneath the

skin can result from silicone injection, leaving

deformities that can only be treated by surgical

excision. The plaintiffs claims of local damage

following silicone injection in the 1994 Georgia case

Knight v. Sturm are typical; in affirming the judgment

against the doctor, the Court of Appeals focused on

the fact that the injections administered between 1986

an 1988 were illegal.'66

A larger legal problem related to silicone fluid has

to do with its presence in silicone gel, the substance

used to fill breast implants. Dow's investigational

concerns about

----------------------------------------------

163 N. , testimony at Hearings before the

Human Resources and Intergovernmental Relations

Subcommittee of the Comittee on Government Operations,

December 18, 1990.

164 Personal communication, Frederick Ellis, Boston,

Mass., Jan. 16, 1997.

165 See, for example, v. Orentreich, 1995

U.S. Dist. Lexis (S.D.N.Y. June 9, 1995)

66 Knight v. Sturm. 442 SE. 2d 255, 1994.

-34-

------------------------------------------

silicone fluid were eclipsed in the 1970's by their

preoccupation with the fabrication of breast implants;

it seemed that the problems with silicone fluid were

set aside as the breast implant business grew. By the

mid-1970's, Dow Corning's Medical Products Division

had seen itself grow from a one million dollar

business in 1965 to a thirty million dollar concern;

much of that growth was due to breast implants.'67

When regulatory difficulties with the FDA required

limiting silicone injection use to a small number of

rare deformities, the potential market for the product

was markedly constricted. It is understandable that

Dow Corning would see a shift of energies from

silicone injection research to silicone breast

implants as a wise business decision. But Dow Corning,

ironically, was not able to get away from silicone

fluid after all. Silicone gel, as it is found in

breast implants, is made up of a framework of

long-chain silicone polymers whose interstices are

filled with silicone fluid of varying viscosity.'68

Some of the fluid used is the same substance used for

injection: Medical Grade 360 or its equivalent.'69

Two of the known complications of silicone gel breast

implants are gel bleed and implant rupture.'70 Though

controversy still rages as to the frequency and

clinical significance of these phenomena, it is agreed

that the extravasation of gross or minute quantities

of silicone gel from the implant shell brings the gel

into contact with the body.'7' If silicone fluid is

part of the gel, implant rupture allows contact

between human tissues and silicone fluid. If gel bleed

represents the transudation of low molecular weight

particles through the selectively permeable implant

shell, then this shell may act as a filter to permit

-------------------------------------------

167 Warrick, Forty Years .... p. 270.

168 LeVier, et al., " What is silicone. "

169 R. Blocksma, deposition testimony In the Matter of

Silicone Breast Implants, MDL 926, Vol. I, pp.

220-221, July 27, 1994.

170 M. McGrath and B. Burkhardt, " The safety and

efficacy

171 B. Silverman. L. Brown, R. Bright. et al.,

" Reported complications of silicone gel breast

implants: an epidemiological review, " Ann. mt. Med.

124:744, 1996.

-35-

---------------------------------------------

the selective migration of silicone fluid into the

tissues.'72 If some connection between silicone gel

implants and connective tissue disease can be proven,

these low molecular weight particles -- similar to

those that make up silicone fluid -- perhaps may

participate in the disease mechanism.

The intensity of the debate surrounding silicone

breast implants stands in stark contrast to the lack

of public attention directed towards silicone

injections in recent years. Perhaps the technique has

been set to one side, as possessing only historical

interest despite its possible relevance to the larger

problems that silicone gel involves. There are other

explanations for this attitudinal inconsistency,

though. The medical community lost its commitment to

the silicone injection techniques, perhaps in the face

of government regulation that restricted its use to

rare conditions. It is possible, too, that physicians

responded to the negative publicity in the popular

press surrounding the techniques; physicians are not

immune to the influence of the media. Why, then, did

surgeons continue to rally to the defense of silicone

gel breast implants, despite a storm of negative

publicity? This question has not yet been resolved.

Possible answers have been proposed:

Marcia Angell contends that doctors stood by breast

implants because of their scientific convictions;'73

more cynical observers suggest that the lucrative

nature of the breast implant business inspired the

dedication of manufacturers and physicians alike to

the product's cause.174 In any case, by the

mid-1970's, silicone breast implants superseded

172 These hypotheses are intensely debated in the

scientific literature and in the courtrooms. I make no

effort to resolve this debate here. For an exhaustive

compilation of bibliographic material and a fairly

unbiased scientific evaluation of the relevant

literature, see Hall et al. v. Baxter Healthcare Corp.

et al. 1996 U.S. Dist. Lexis 18960 (Or., Dec. 18,

1996), where the trial judge conducted a hearing on

the defendants' motions in limine to exclude the

evidence submitted by the plaintiffs' experts about

adverse systemic effects of silicone gel. The judge

exercised his discretion under FRE 104 to appoint

technical advisors to help him determine the

scientific merits of the proffered testimony.

~ M. Angell, S~kn ..~n..lil (New York: W.W. Norton,

1996). The subtitle of her book, " The Clash of Medical

Evidence and the Law in the Breast Implant Case, "

points to a siege mentality that has beset some

members of the medical community who feel that the

very foundations of the profession are being attacked

by the forces of greed and irrationality.

~ It seems fair to say that this theme is part of J.

Byrne's message in Informed Consent.

-36-

---------------------------------------------------

breast injections as the answer to what was described

as " woman's eternal dream --beautiful, firm and

harmoniously proportioned breasts -- a dream that has

inspired painting, sculpture and literature since the

dawn of mankind [sic]. " '75 In an age where sex was

seen as what sells products, silicone injections had

been marginalized to the treatment of obscure and

distinctly unsexy conditions.

B. Ethical issues

" Those who forget the past are condemned to repeat

it. "

-- Santayana

The active questions that remain about the ongoing

effects of silicone fluid in injection and implant

patients may ultimately be answered by scientific

data. Larger policy questions are raised by the

behavior of those who undertook to introduce this

substance into the bodies of human beings without

adequate data about safety and often without informed

consent. While it is easy to attack such conduct, it

is better to understand. While it seems clear in

retrospect why Dow Corning abandoned its clinical

investigation of silicone fluid when it did, it seems

less clear why the company carried out its earlier

investigations the way it did.

It is easy, from the perspective of the late 1990's,

to criticize all who were

involved. The big corporation shirked its duty to

prove its product safe for human use; doctors betrayed

their patients by using them as guinea pigs in medical

experimentation; the FDA failed to enforce the

regulations that protected the public. But

investigating the history of the times when these

lapses occurred leads to the conclusion that the easy

criticisms fail to do justice to sociocultural

realities. The fact is that these decisions made in

the 1950's and early 1960's were based on a somewhat

different set of moral presuppositions than what

guides such decision-making today. As Silas Braley

told Byrne,

--------------------------------------

~ ~ Lalandrie and R. Mouly, " History of mammaplasty, "

p. 167.

-37-

-----------------------------------

At that time, there were no tests for implant

materials. There was no protocol at the FDA. If you

wanted to test a device for the FDA, how would you do

it? Do you feed it to a patient? What do you do? You

put it under the skin of a patient and look and see

what happens. And that is what we had done in many

cases -

- all of which reinforced the knowledge that these

materials were satisfactory for use as far as we knew

at the time and were infinitely superior to anything

that was available as a substitute.'

We can derive historical lessons from these decisions

in the past, but we cannot moralize quite so easily.

The " 20/20 hindsight " with which we criticize the

participants in the silicone injection debacle fails

to take account of the dramatic evolution of mores

that has taken place over the past forty years. The

sexism, for example, that seems to pervade the actions

of Dow Corning employees and many plastic surgeons

only became identified as a cultural concept in the

late 1960's via the Women's Movement. There seems to

be little precedent in the 1950's and early 1960's for

treating women in general and women patients in

particular as the equals of men.

Attitudes in medical practice of the times reinforced

the inferior status of the woman patient: patients in

general tended to be approached paternalistically by

physicians.'77 Not until the consumer activism of the

late 1960's impelled customers to ask for more

information about products and services did we see a

comparable demand within the doctor-patient

relationship that the patient's autonomy determine her

medical destiny.'78 It is therefore not surprising

that the participants in the project saw nothing wrong

with their actions. From the moral perspective of the

times, exploitation of women and experimentation upon

human subjects may have been business as usual.

--------------------------------------------

176 J~ Byrne, Informed Consent. p. 47.

177 See, for example, J. Katz, The Silent World of

Doctor and Patient (New York: The Free Press, 1986).

An entire issue of Theoretical Medicine is devoted to

the physician's ways of influencing patient decision

making through persuasion, manipulation and coercion.

See Theor. Med 7:104-161, 181-194, 1986.

78 R. Faden and T. Beauchamp. A History and Theory of

Informed Consent (New York: Oxford Univ. Press, 1986).

-38-

---------------------------------------

This moral relativism, however, cannot coexist with

the fundamental principles that have guided medical

research since the Nuremberg Trials. The Nuremberg

Code of 1947 set forth informed consent of the human

subject as a bedrock principle.'79 The importance of

this norm certainly was familiar to American citizens

in the 1950's who had heard the horror stories of Nazi

medical experiments. Further,the fiduciary nature of

the doctor-patient relationship was well understood by

medical practitioners of that time.'80 Conflicts of

interest between the physician as experimenter and the

physician as therapist could be appreciated even in

the 1950's within the context of well-accepted medical

ethics.'8'

So to say that the behavior of those involved with

silicone injections was culturally understandable

dodges the moral question: was it wrong? From the

perspective of medical ethics, the failure of the

experimenters to accumulate adequate animal data and

the lack of a rigorous program of informed consent

were both moral failures. What do these failures say

about the individuals who were involved in carrying

out the investigations? It is tempting to point a

finger at Dow Corning or at individual physicians to

allocate blame. But from a review of the history, it

seems that the standard of culpability was more likely

negligence than reckiessness, especially considering

the cultural climate of the times.

Why do " good " people do " bad " things? This

philosophical question has preoccupied religious and

secular moralists for millenia. In this case, a close

reading of the texts of the times reveals a scientific

and technical optimism that suggests that participants

in the silicone fluid project genuinely thought that

they were doing " good " rather than " bad. " Combined

with this optimism was a technological arrogance about

human ability to

------------------------------------------

~ Trials of War Criminals before the Nuremberg

Military Tribunals under Control Council Law, No. 10

(Washington, D.C.: GPO, 1949).

180 E. Frsedson has been an articulate commentator on

the sociology and social ethics of the profession. See

E. Friedson, Professionalism Reborn (Chicago:

University Press, 1994) for a compendium of his work.

181 Exploring this social history exceeds the purview

of this paper. See, for a lucid examination of the

socioeconomical development of the profession, P.

Starr, The Social Transformation of American Medicine

(New York: Basic Books, 1982).

-39-

-------------------------------------------------

solve human problems; scientific problem-solving did

not require moral scrutiny because it was good in

itself.'82 Only after scientists began to reflect upon

the human consequences of technical progress was this

hubris challenged.'83 Most philosophers recognize that

culture and morality must constrain science, not the

progress of science alone.'84

While it may be difficult to allocate blame in any

moral or legal sense to the participants in the

silicone injection project, we can draw some

conclusions for the future. The traditional dedication

of the physician to the patient is a touchstone in

medical practice, even in medical experimentation. The

doctor has a moral obligation to ensure to his or her

own satisfaction that a treatment modality is safe and

effective before recommending it. The doctor-patient

relationship, though, is founded on the principle of

autonomy: this requires some form of informed consent

in virtually every therapeutic transaction. We have at

hand a body of normative doctrines that have been

applied to medical practice across time. Adhering to

these principles might have prevented many of the

abuses that resulted from silicone injections. Another

ethical line of defense is established by the

procedural formalities that protect human subjects in

medical experimentation. The researcher has an

obligation to adhere to these regulations in spirit as

well as in letter. Such moral rigor again would have

protected many of those patients injured by silicone

injections.

Checks and balances have been established by law to

protect the public from situations like this. The IRB

system, whereby institutions receiving federal funds

are required to conduct prospective and ongoing review

of all biomedical research involving

------------------------------------------

182 Recall the Dow Chemical slogan in the pre-napalm

1960's: " Better living through chemistry. "

183 See M. Polanyi, Personal Knowledge (New York:

Oxford, 1962), for example. Here a physicist

reexamines the epistemological bases of scientific

objectivism after realizing the moral consequences of

modern physics.

'~ The rules protecting patients in medical

experiments emanate from philosophical principles, not

scientific ones. Science is different from speech: the

cure for dangerous science is not more science; rather

science is to be governed by human norms of morality.

The doctrine of informed consent, for example, is

based upon the Kantian principle of respect for

persons.

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human subjects, has specific requirements.'85 It is

likely that any research like that performed with

silicone fluid would have to pass some type of IRB

review. More comprehensively, the FDA has a specific

mandate to require manufacturers to prove new drugs

and devices safe and effective.186 Though the FDA of

the 1960's and 1970's may seem lax by comparison to

its present activism, it ultimately did its job in

driving silicone injections out of business. One can

argue for a more aggressive regulatory stance if

problems like those caused by silicone injections are

to be avoided in the future.

The possibility of a stronger FDA is met with

resistance in the medical community. Government

regulation is seen as inhibiting access to important

drugs and devices and increasing overall health care

costs. Critics note that the FDA interferes with

patient autonomy and restricts the autonomy of

legitimate science.187 Kessler, in response,

reiterated the principles that guide the agency:

The FDA was established as a result of social mandate.

Caveat emptor never has been -- and never will be --

the philosophy at the FDA, Manufacturers have vested

interests. Between those interests and the interests

of the patients, the FDA must be the arbiter. To argue

that people ought to be able to choose their own

risks, that government should not intervene even in

the face of inadequate information, is to impose an

unrealistic burden on people when they are most

vulnerable to manufacturers' assertions... 188

The history of experimentation with silicone

injections shows the importance of regulation in

curtailing irresponsible practices. The medical use of

silicone fluid demonstrates that the informal moral

and social controls that serve to protect patients do

not always work. This history argues for a stronger

regulatory stance in these times when medicine and

science alike are impacted by economic incentives that

conflict with human safety.

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~ " Protection of human subjects, " 45 CFR 46, 1983. 196

21 USCA. §360.

187 M. Angell, " Breast implants -- protection or

paternalism? " NEJM 326:1695, 1992; 1. Fisher, " The

silicone controversy -- when will science prevail? "

NEJM 326:1969, 1992.

'~ D. Kessler. " The basis of the FDA's decision on

breast implants, " NEJM 326:1713, 1992.

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Silicone breast implants and their poor cousin

silicone injections rank among the industrial crises

-- thalidomide, asbestos, Three Mile Island -- that

have changed the way we conduct business as usual. In

a technological society, we all recognize that there

is some assumption of risk. But these represent

situations where the market has failed to ensure a

publicly desirable level of safety, so that regulators

had to become involved. Ex ante, the cry is too much

regulation -- stifling innovation. Ex post, we wonder,

" Could this tragedy have been avoided? " In a society

of fallible people pursuing disparate interests under

conditions of uncertaint, there is always the

potential for disaster. Public policy will find itself

always challenged to tread the fine line between

overreaching and permissiveness.

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