Dr. Blais on Saline breast implants

[Guest guest]

Part 1

SALINE-FILLED BREAST IMPLANTS - A CONTINUING AREA OF CONCERN

P. Blais, INNOVAL, 496 Westminster Avenue, Ottawa, Ontario K2A 2V1

Canada

Introduction:

Innoval has conducted studies on saline inflatable breast prostheses for

nearly ten years, continuing work initiated by Canadian researchers in

the early-eighties. Problems with these devices were discovered early

and motivated proposals to amend the Canadian Medical Devices

Regulations. The work was the object of publications which have not been

widely disseminated.

Control of commerce in breast implants has been difficult and costly.

Early efforts are credited to the FDA in the mid-seventies culminating

in recommendations for better mechanisms of approval and upgraded

post-market follow-up as early as 1978. Saline inflatable breast

implants were areas of concern then and remain central today. The need

for mandatory filing of pre-market approval applications (PMA) and

updated Notices of Completion of a Product Development Protocol (PDP)

for this class of product is clearly demonstrated and urgent in the

light of continuing performance shortfalls and alarming patterns of

adverse reaction.

Field reports on failures and adverse reactions from saline inflatable

prostheses are not comprehensive. There is a history of under-reporting

which has worsened significantly since 1990. Field report data do not

realistically assess the extent or severity of complications. Promotion

of the technology is at an all time high and shows no sign of abating.

Published information on the realities of the technology is sparse and

incomplete. There is suppression of information regarding untoward

events and service failure of the items. Any committee engaged in review

of safety and efficacy of saline inflatable prostheses will not have

access to all data. Publicly mandated committees will not be able to

derive informed conclusions and policies without access to implant

retrieval programs and independent laboratory studies. Epidemiology

studies are distorted by a background of natural morbidity involving the

disease prone female breast. The situation is significantly worsened by

heavy industry sponsorship of university research, lobbying and

conflicts of interest with many key researchers and clinicians presented

as independent intervenants.

Amongst all commercially made saline inflatable prostheses, there is not

one currently in use which could be construed as being substantially

equivalent to a product made before May 28, 1976, the watershed date for

U.S.F.D.A. medical device regulations. The products have undergone

drastic changes at regular intervals as product design fashions,

production machinery and raw material vendors changed. This view is

confirmed in manufacturers' advertisements and promotional material to

physicians and the public where the products are claimed to be novel and

significantly improved from what was made previously. To date, there has

been no perceptible change in the lackluster performance of the

products.

General Aspects of Saline-Filled Breast Implants:

Breast implants are flexible plastic shells fitted with filling ports

and filled with water-based fluids. They have been described in

publications and patents for more than forty years. Commercially made

items appeared during the sixties. Since then, more than eighteen

manufacturers have made such products. About seven remain active.

Current devices have not significantly evolved since the seventies and

problems of product quality and durability remain. Adverse reactions

continue unabated. Promotion and de-emphasis of risks are stronger than

ever with new generations of users swelling an existing pool of injured

users.

Saline inflatable breast implants are widely promoted for cosmetic

augmentation. In the early seventies, they represented less than 10% of

the total breast prosthesis market. Many products were withdrawn in the

eighties following pandemic failures and lawsuits. By 1984, the salines

had nearly vanished. In 1992, the year when the FDA imposed a Moratorium

on gel-filled breast implants, the number of new saline users in the

U.S. increased by about 30,000 women. In 1997, new implantations were

about 122,000. In 1998, about 132,000 women received saline implants for

the first time. Worldwide, an increase of about 210,000 new users

appeared in 1999, mostly in North America. The number of new implant

users is growing at a compound rate of about 15% per year with Mexico,

Latin America, Eastern Europe and the Far East reporting the most rapid

rise.

Less than 5% of new users are breast cancer patients, nearly unchanged

for the last two decades. The dominant part of the user population

consists of cosmetic surgery clients seeking to augment breast size.

About 9-10% of current users are replacement patients who had earlier

implants that failed and left them disfigured. This number is rising,

reflecting maturation, failures and 'wear out' of poorly made saline

inflatable devices inserted in the mid-nineties.

The primary saline implant manufacturers are currently McGhan Medical

Corporation (Inamed), Silimed S.A., Mentor H/S Corporation, NovaMed

Inc., Poly Implant Protheses (PIP) S.A. and Progress Mankind Technology

(PMT) GmbH. The U.S. is dominated by Mentor and McGhan who share the

market. Secondary distributors include Hutchinson International and

Sierra Medical Technologies Inc. There is an influx of unsanctioned

foreign products imported and inserted in U.S. users at offshore clinics

which advertise within the continental U.S.

All salines use basically the same concepts, components and materials.

Dominant suppliers of silicone intermediates include McGhan Nusil

Corporation (Inamed), Applied Silicone Corporation (Rhodia) and Dow

Corning Corporation. Stock parts for some valved devices are supplied as

commodities from U.S.-based corporations.

Lack of durability, fluid leakage, frequent replacements, adverse

reactions and litigation have surrounded this technology from the

outset. Late-nineties saline inflatable implants still have short

service lives. They reflect antiquated designs and low quality. Many

show serious fabrication defects. Implants that do not deflate

noticeably at first become progressively less satisfactory with the

onset of pain and deformity over time. Users inevitably must undergo

more surgery with worsening cosmetic results and increased discomfort.

In spite of rising problems of safety and durability, severe injury

potential and large public health care costs, usage continues to rise,

driven by misleading promotion.

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