Re: Fw: Subject Reference: Fw: SILICONE BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

[Guest guest]

Dr Kolb, I'm curious, since you replaced your gels with saline, do

you have textured or smooth? Also do you think there are more

problems with the Mc Ghans textured? I see a lot of women on here

seem to have the same brand of Mc Ghans textured 168's. Also it seems

there are certain years that many women on this forum got implants

and have problems, could there be a problem with the way the implants

were made in those years? I'd like to know what implant you used on

yourself. Thanks Nik

> > >

> > > ----- Original Message -----

> > > From: Dr. Kolb <drkolb@m...>

> > > Patty <fdp@l...>; <Carina063@h...>

> > > Sent: Tuesday, January 22, 2002 8:43 AM

> > > Subject: Fw: Subject Reference: Fw: SILICONE BREAKDOWN AND

CAPSULAR

> > SYNOVIAL

> > > METAPLASIA IN

> > >

> > >

> > > > : This is an article which describes what is well

known in

> > silicone

> > > > biomaterials research. The clinical experience of all

doctors I

> > have

> > > spoken

> > > > with is that textured implants are much more likely than

smooth

> > to cause

> > > > problems both systemic and local. In 1997 when I had my

implants

> > replaced

> > > > we did not have clinical evidence that smooth saline implants

> > that were

> > > not

> > > > infected were nearly as dangerous as leaking silicone gel

> > implants. We

> > > > still do not have this evidence. I have never stated that

smooth

> > implants

> > > > are safe. I am still trying to identify what puts a patient at

> > risk. All

> > > > plastic surgeons that you recommend on this board put in

smooth

> > saline

> > > > implants so it is unfair to single me out as you have done in

the

> > past.

> > > You

> > > > misunderstood what I was saying in the posts. I would again

ask

> > you to

> > > > carefully read what is said before jumping to conclusions. You

> > are at a

> > > > higher level of responsibility as a moderator. .

> > > > ----- Original Message -----

> > > > From: Martha Murdock & (gigi*) Lawrence <MAM-NSIF@P...>

> > > > BreastImplantNews <BreastImplantNews@t...>

> > > > Sent: Tuesday, January 22, 2002 1:05 AM

> > > > Subject: Subject Reference: Fw: SILICONE BREAKDOWN AND

CAPSULAR

> > SYNOVIAL

> > > > METAPLASIA IN

> > > >

> > > >

> > > > > ============================================================

> > > > > Debt Worries? Get Relief Now! Free Online Consultation

> > > > > Get Out of Debt Quickly - No Credit Check!

> > > > > No More Harassment! Eliminate Interest & Late Charges!

> > > > >

> > http://click.topica.com/caaafxja2iT7oa3jrjha/FirstMutualFinancial

> > > > > ============================================================

> > > > >

> > > > >

> > > > > From: " Myrl Jeffcoat " <myrlj@j...>

> > > > > Sent: Monday, January 21, 2002 11:40 PM

> > > > > Subject: SILICONE BREAKDOWN AND CAPSULAR SYNOVIAL

METAPLASIA IN

> > > > > TEXTURED-WALL SALINE BREAST PROTHESIS

> > > > >

> > > > >

> > > > > SILICONE BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

TEXTURED-

> > WALL

> > > > SALINE

> > > > > BREAST PROTHESIS

> > > > >

> > > > > http://www.newwomyn.com/nw012i.html

> > > > >

> > > > > Authors: Copeland, Choi, Bleiweiss

> > > > > Source: Plastic & Reconstructive Surg Jnl, October, 1994,

Vol.:

> > 94, No.

> > > 5,

> > > > > 628-633

> > > > > Address: Mt. Sinai Medical Center, NY.

> > > > >

> > > > > Saline-filled prostheses are currently the only type of

> > prostheses

> > > > available

> > > > > for cosmetic use in the U. S. because of concerns raised

about

> > the

> > > > > possibility of systemic toxicity of silicone-filled

artificial

> > mammary

> > > > > implants. Although the approved implants are saline-filled,

> > their

> > > > potential

> > > > > to release silicone particles from the shells has not been

> > > systematically

> > > > > evaluated. We performed microscopic examination of the

> > pericapsular

> > > tissue

> > > > > of 54 patients with textured-surface implants and compared

> > these with 51

> > > > > patients with smooth- walled implants over a two year

period.

> > > > >

> > > > > The capsules that had formed around virtually all textured-

> > surface

> > > > implants

> > > > > had silicone fragments present either in extracellular

spaces,

> > in

> > > > vacuolated

> > > > > histiocytes, or in the form of foreign-body granulomas in

> > surrounding

> > > > > fibroadipose tissue but not in capsules associated with

smooth-

> > walled

> > > > > implants. In 87% of samples of pericapsular tissue from

> > textured saline

> > > > > implants, the contact surface displayed exuberant reactive

> > synovial

> > > > > metaplasia, a histologic pattern not previously described

with

> > these

> > > > > devices.

> > > > >

> > > > > Our finding suggest that smooth-walled prostheses are

> > associated with

> > > less

> > > > > silicone fragmentation than textured devices in the peri-

> > implant tissue

> > > > > capsules that tend to form around artificial surfaces used

for

> > this purp

> > > > > ostheses have been implicated in connective tissue

inflammatory

> > > syndromes

> > > > > including systemic sclerosis.1-9 The U. S. Food and Drug

> > Administration

> > > > > (FDA) curtailed the clinical use of these implants in 1992

> > because of

> > > > > questions concerning the safety of silicone contents.10,11

> > Saline filled

> > > > > mammary implants also have a silicone shell but are filled

with

> > saline

> > > and

> > > > > are therefore considered safer, since resorption of an

> > innocuous fluid

> > > > would

> > > > > be expected to occur in the event of rupture or leakage of

the

> > > prosthesis.

> > > > > These are currently the only breast prostheses available for

> > cosmetic

> > > use

> > > > in

> > > > > the United States. Both smooth walled and textured surface

> > implants are

> > > in

> > > > > widespread clinical use as implants and as tissue expanders.

> > Many

> > > surgeons

> > > > > favor textured implants, which are reportedly less prone to

> > capsular

> > > > > contracture and may produce a smoother, softer result.12-17

> > Textured

> > > > > prostheses are often selected not only for primary

mammoplasty

> > but also

> > > as

> > > > a

> > > > > replacement device for patients who seek removal of silicone

> > filled

> > > > > implants.

> > > > >

> > > > > To determine the histologic characteristics of capsular

tissue

> > excised

> > > in

> > > > > association with saline filled breast implant removal, we

> > reviewed the

> > > > > surgical specimens of patients undergoing prosthesis

removal at

> > the

> > > Mount

> > > > > Sinai Medical Center in 1992 and 1993. Although not prone to

> > spillage of

> > > > > encased silicone, saline-filled breast implants have a

silicone

> > lining.

> > > > Our

> > > > > results raise concerns about tissue reaction to the linings

of

> > all

> > > > > artificial prostheses but about textured surface implants in

> > particular.

> > > > >

> > > > > MATERIAL AND METHODS

> > > > >

> > > > > One-hundred ninety-one mammary implants were removed at the

> > Mount Sinai

> > > > > Medical Center during 1992-1993 from 139 patients. These

> > implants had

> > > been

> > > > > in place for varying periods of time, ranging from 6 weeks

to

> > several

> > > > years.

> > > > > The implants were removed for a variety of reasons,

including

> > staged

> > > > > reconstruction procedure and patient dissatisfaction with

size,

> > shape or

> > > > > type of implant.

> > > > >

> > > > > Surgical pathology specimens of 57 saline filled implants

(54

> > patients)

> > > > > included portions of t fibrous tissue capsules, all of which

> > were

> > > examined

> > > > > histologically. Fifty-four of the saline filled implants

were

> > textured

> > > > > surface prostheses, and the other three were smooth walled

> > implants.

> > > > > Forty-nine (91%) of the textured saline implants were McGhan

> > Biospan

> > > > tissue

> > > > > expanders that had been placed under the pectoralis muscle

for

> > breast

> > > > > reconstruction after mastectomy and inflated according to

the

> > > > manufacturer's

> > > > > recommendations and serially expanded over a course of 6 to

25

> > weeks.

> > > > >

> > > > > For comparison we examined the 92 peri-implant capsules of

51

> > patients

> > > > whose

> > > > > (mostly bilateral) silicone gel implants were removed; 90 of

> > these were

> > > > from

> > > > > smooth walled silicone implants and 2 were textured walled.

> > Surgical

> > > > > pathology specimens were prepared with 10% buffered

formalin,

> > embedded

> > > in

> > > > > paraffin, and stained with hematoxylin and eosin for

microscopic

> > > > examination

> > > > > under direct incident and polarized light. Immuno-

histochemical

> > studies

> > > of

> > > > > selected areas in two samples were carried out using

monoclonal

> > > antibodies

> > > > > directed against vimentin, desmin (both Biogenex

Laboratories,

> > Dublin,

> > > > > Calif.), antitrypsin, lysozyme, myoglbin (Dako Laboratories,

> > Inc., Santa

> > > > > Barbara, Calif.), macrophage marker, myocyte actin HHF-35

(Enzo

> > > > > Laboratories, Syosset, NY), cytokeratin (Becton Dickinson

> > Laboratories,

> > > > > Inc., Mountain View, Calif.), and another macrophage marker

(KP-

> > 1,

> > > > courtesy

> > > > > of Dr. Strauchen).

> > > > >

> > > > > RESULTS

> > > > >

> > > > > Light microscopic examination of the fibrous capsules

> > associated with 46

> > > > of

> > > > > 54 textured walled saline implants revealed large fragments

of

> > silicone

> > > > > within giant cell granulomas. For example, the inner lining

of

> > one was

> > > > > arranged in a pseudopapillary configuration resembling

synovial

> > tissue.

> > > > The

> > > > > deeper tissue showed foreign-body granulomas containing

> > fragments of

> > > > > silicone.

> > > > >

> > > > > Hematoxylin and eosin staining left silicone colorless,

> > refractile to

> > > > > decreased incident light, and onbirefringent in polarized

> > light. These

> > > > > granulomas were found exclusively in tissue deep to the

capsule

> > itself

> > > > > rather than proximate to the prosthetic surface. Silicon in

> > diameter

> > > > within

> > > > > foreign body giant cells. Unlike " gel bleed " silicone, which

> > usually

> > > > appears

> > > > > as diffuse extracellular material or in microvesicular form

> > within

> > > > > histiocytes, the silicone associated with textured saline

> > implants was

> > > > > entirely intracellular and compact. Many capsular sections

had

> > an inner

> > > > > lining containing wide pseudopapillary formations

> > histologically nearly

> > > > > indistinguishable from synovial tissue. High powered view

of an

> > area of

> > > > one,

> > > > > for example, revealed that the inner surface of the capsule

is

> > composed

> > > of

> > > > > palisading, uniform epithelioid cells. Silicone was visible

as

> > large,

> > > > > refractile, nonpolarizable fragments contained within

> > aggregates of

> > > > > foreign body type giant cells.

> > > > >

> > > > > The surface that had been in contact with the prosthesis

had a

> > > > discontinuous

> > > > > layer of epithelioid columnar cells with polarized and

> > occasionally

> > > > > palisading nuclei. Beneath this layer, making up the core

of the

> > > > > pseudopapillae, was a layer of histiocytes and fibroblasts

> > associated

> > > with

> > > > > dense collagen both perpendicular and parallel to the

surface.

> > Deep to

> > > > this

> > > > > layer was vascular fibrofatty tissue. This type reaction--

> > synovial

> > > > > metaplasia--was found in varying intensity in 47 of the 54

> > patients with

> > > > > textured walled saline (87%). One of 47 with synovial

> > metaplasia was

> > > > > associated with an MSI implant, which has a brushlike

textured

> > silicone

> > > > > surface, but no silicone fragments were identified in this

> > case. The

> > > > > remaining 7 patients had densely fibrous connective tissue

> > capsules with

> > > > > little or no cellular reaction at the inner surface; there

was

> > wall

> > > > > calcification in one. Immunohistochemcial studies

demonstrated

> > surface

> > > > > epithelioid cells strongly positive for vimentin and

negative

> > for

> > > > > cytokeratin and all other antigens tested. The underlying

> > fibroblast and

> > > > > histiocytes also were positive for vimentin (antigen),

although

> > less

> > > > > intensely and less consistently positive for antitrypsin,

> > lysozyme,

> > > > > macrophage marker, and KP-1. Stains for muscle markers

(desmin,

> > > myoglobin,

> > > > > and mycyte actin HHF-35) were negative in all types

> > > > > of cells. Three were fibrous and generally acellular. No

> > silicone

> > > > fragments

> > > > > were identified in association with this type prosthesis.

> > > > >

> > > > > The capsules of 90 specimens obtained from 51 patients with

> > smooth

> > > walled

> > > > > silicone gel implants showed no synovial metaplasia. These

> > capsules

> > > almost

> > > > > uniformly consisted of densely fibrotic tissue, sometimes

> > calcified,

> > > > > associated with histologically identifiable silicone in

small

> > amounts

> > > with

> > > > > intact implants and in larger amounts when the implant had

> > ruptured.

> > > > > Silicone was present in extracellular spaces or in

vacuolated

> > > histiocytes

> > > > or

> > > > > both. Two additional capsules were from double lumen

implants

> > that had

> > > > > silicone on the outside and saline on the inside. The

> > pericapsular

> > > tissue

> > > > > from one of the double lumen implants showed a minor degree

of

> > focal

> > > > > synovial metaplasia. No silicone fragments were identified

in

> > > association

> > > > > with this type of prosthesis.

> > > > >

> > > > > DISCUSSION

> > > > >

> > > > > The possible association of silicone gel breast implants

with

> > certain

> > > > > connective tissue disease syndromes1-7 prompted the Food and

> > Drug

> > > > > Administration to curtail use of these devices in surgical

> > practice.

> > > > Saline

> > > > > filled prostheses and tissue expanders remain available and

are

> > widely

> > > > > viewed as safer, 10,11 even though their walls are composed

of a

> > > silicone

> > > > > elastomer. Textured surface implants are reputed to produce

> > better

> > > > cosmetic

> > > > > results and few complications related to capsular

contracture

> > than

> > > smooth

> > > > > walled prostheses or expanders, although these observations

> > have not

> > > been

> > > > > adequately tested in randomized trials.12,17 Our findings

> > demonstrate

> > > that

> > > > > saline filled implants may release fragments of silicone

into

> > the

> > > > > surrounding tissues and that textured surface implants may

be

> > associated

> > > > > with synovial metaplasia.

> > > > >

> > > > > In 1990, Maxwell and Falcone13 described 84 consecutive

breast

> > > > > reconstructions using textured silicone tissue expanders and

> > reported no

> > > > > visible silicone particles in the capsules after the

expanders

> > were

> > > > removed.

> > > > > Barone et al.16 observed, in a rabbit model, that capsules

> > surrounding

> > > > > smooth walled prostheses were relatively acellula s.

Capsules

> > around

> > > > > textured implants contained histiocytes, giant cells, and

> > intracellular

> > > > > silicone fragments. Although photomicrographs were not

> > provided, this

> > > > > reaction seems analogous to the pattern of synovial

metaplasia

> > we

> > > observed

> > > > > in the majority of our textured implants. Capsular tissue is

> > > infrequently

> > > > > excised when saline implants and expanders are removed, and

> > this account

> > > > for

> > > > > the small number of specimens available for analysis. Our

> > experience has

> > > > > been, however, that when capsules are removed and

histologically

> > > examined,

> > > > > silicone fragments are a frequent finding.

> > > > >

> > > > > Silicone was located within granulomas in fibroadipose

tissue

> > deep to

> > > the

> > > > > capsular surface, and therefore, the presence of silicone in

> > the capsule

> > > > > cannot be explained by mechanical disruption of the

elastomer

> > surface

> > > > during

> > > > > implant explantation. Furthermore, a granulomatous reaction

> > takes

> > > several

> > > > > days to develop, so fragmentation of silicone during

> > explantation could

> > > > not

> > > > > account for this histologic picture.18 Synovial metaplasia

> > developed in

> > > a

> > > > > number of cases, and it seems reasonable to speculate that

this

> > is a

> > > > > response to the textured surface and not to silicone.

Indeed,

> > in one

> > > > capsule

> > > > > that formed around a brushlike textured surface MSI saline,

> > implant, no

> > > > free

> > > > > silicone was found, yet there was extensive synovial

> > metaplasia. None of

> > > > the

> > > > > smooth walled saline implants showed capsular silicone

> > fragments, and

> > > > > synovial metaplasia was seen focally in only one case.

> > Examinations of a

> > > > > larger number of specimens will be necessary to permit

proper

> > > conclusions

> > > > > about the relative safety of smooth versus textured walled

> > prostheses.

> > > > > Synovial metaplasia (metaplastic synovial cyst formation)

is a

> > tissue

> > > > > reaction first described in chickens with experimentally

> > implanted

> > > > silicone

> > > > > joints by Brody and White19 and in humans after total hip

> > replacement by

> > > > > Goldring et al.20 Synovial membranes were described at bone

> > cement

> > > > > interfaces and resembled reactive synovium. Similar

phenomena

> > have been

> > > > > reported in skin and subcutaneous tissue at sites of

previous

> > surgery or

> > > > > trauma.21-26 Immunohistochemical findings were similar to

those

> > we

> > > > observed

> > > > > with breast implants: positive staining of the epithelioid

> > cells for

> > > > > vimentin and inconsistent positivity in underlying cells for

> > > antitrypsin,

> > > > > and lysozyme (macrophage markers); KP-1, an additional

> > macrophage

> > > marker,

> > > > > was negative. Epithelial markers (cytokeratin, AE-1,

> > > > > and EMA) were uniformly negative in all cells. Although by

no

> > means

> > > > > specific, these staining characteristics are typical of

normal

> > > > synoviocytes.

> > > > > We also found negative staining with muscle markers (MCA,

> > desmin, and

> > > > > myoglobin), excluding myfibroblastic differentiation.

> > > > >

> > > > > A few cases of metaplastic synovial cysts have been

described

> > containing

> > > > > clear, vicious fluid,26 and these suggest that cells may

have

> > secretory

> > > > > functions similar to those of normal synovium. We found such

> > fluid in

> > > one

> > > > > patient between the capsule and the outer surface of a

textured

> > saline

> > > > > implant. We postulate that a secretory mechanism may be

operant

> > in

> > > > textured

> > > > > surface breast implants and expanders corresponding to the

> > clinical

> > > > tendency

> > > > > to seroma formation, requiring drainage at the time of

> > implantation.

> > > > > Although improved cosmetic results reported with textured

> > implants have

> > > > been

> > > > > attributed to better tissue fixation,15-17 they may

actually be

> > related

> > > to

> > > > > greater movement stimulating synovial evolution.27-28

> > > > >

> > > > > The mechanism by which silicone containing prostheses are

> > sometimes

> > > > > associated with systemic inflammatory disorders is not

clear. A

> > foreign

> > > > body

> > > > > histologic reaction to silicone has been described,29 and an

> > association

> > > > > between systemic inflammatory syndromes such as systemic

> > sclerosis and

> > > > > silicone breast prostheses has been reported.1-8 Large

amounts

> > of

> > > silicone

> > > > > may not be required for such responses, and we have

described

> > persistent

> > > > > clinical and serologic evidence of immune inflammation even

when

> > > > microscopic

> > > > > quantities of silicone are left in place in a retained

fibrous

> > capsule

> > > > after

> > > > > removal of silicone filled prostheses. Saline filled

implants

> > are often

> > > > > considered safer than silicone filled implan ar surface of

> > textured

> > > > implants

> > > > > may become incorporated with capsular tissue. This suggests

> > that in

> > > > patients

> > > > > with a history of inflammatory reactions to silicone, smooth

> > walled

> > > saline

> > > > > filled implants may reduce the risk of recurrent problems.

> > > > >

> > > > > Copeland, D. M. D., M. D.

> > > > >

> > > > > We acknowledge the support of the following colleagues for

> > providing

> > > > access

> > > > > to clinical case material: Jin Chun, M. D., Saul Hoffman, M.

> > D., Elliott

> > > > > Rose, M. D., Skolnik, M. D., Carlin Vickery M. D.,

and

> > Hubert

> > > > > Weinberg, M. D. References: Wish to review abstracts of

any of

> > these

> > > > > articles? Most should be available at the following Web

Site .

> > Once

> > > there,

> > > > > click on " Medline " and then scroll to under the search field

> > and click

> > > on

> > > > > " Advanced Search. " Put in the name of one of the authors

that

> > is most

> > > > > unusual and that has two initials available to input for the

> > search.

> > > When

> > > > > you find the article, click to tab it and then go to the

bottom

> > of the

> > > > page

> > > > > and click on " Retrieve Articles. "

> > > > >

> > > > > HEALTHGATE

> > > > >

> > > > > 1. Press, R. I. , Peebles, C. L, Kumagai, Y., Ochs, R. L.

and

> > Tan, E. M.

> > > > > ANTINUCLEAR AUTOANTIBODIES IN WOMEN WITH SILICONE BREAST

> > IMPLANTS,

> > > Lancet,

> > > > > 340, 1304, 1992.

> > > > >

> > > > > 2. Varga, J., Schumacher R. and Jimenez, S. A.. SYSTEMIC

> > SCLEROSIS AFTER

> > > > > AUGMENTATION MAMMOPLASTY WITH SILICONE IMPLANTS. Ann.

Intern.

> > Med., 111:

> > > > > 377, 1987.

> > > > >

> > > > > 3. Spiera, H. SCLERODERMA AFTER SILICONE AUGMENTATION

> > MAMMOPLASTY,

> > > > J.A.M.A,

> > > > > 260: 236, 1988.

> > > > >

> > > > > 4. Truong, L. D., Cartwright, Goodman and Woznicki, D.

SILICONE

> > > > > LYMPHADENOPATHY ASSOCIATED WITH AUGMENTATION MAMMOPLASTY;

> > MORPHOLOGIC

> > > > > FEATURES OF NINE CASES. Am. J. Surg. Pathol. 12: 484, 1988.

> > > > >

> > > > > 5. Brody S. C., SCLERODERMA AFTER AUGMENATATION

MAMMOPLASTY, J.

> > A. M.

> > > A.,

> > > > > 260: 236, 1988.

> > > > >

> > > > > 6. Brozena, S., Fenske N., Cruse, W. Espinoza, C., Vasey,

F. B.,

> > > Germanin

> > > > > and Espinoza, L. HUMAN ADJUVANT DISEASE FOLLOWING

AUGMENTATION

> > > > MAMMOPLASTY.

> > > > > Arch. Dermatol. 126, 1198, 1990.

> > > > >

> > > > > 7. Sahn, E., Garen, P. Silver, R. and Maize, J. SCLERODERMA

> > FOLLOWING

> > > > > AUGMENTATION MAMMOPLASTY. Arch. Dermatol. 126: 1198. 1990.

> > > > >

> > > > > 8. Hirmand, H. Latrenta, G. S. and Hoffman. AUTOIMMUNE

DISEASE

> > AND

> > > > SILICONE

> > > > > BREAST IMPLANTS. Oncology 7: 17, 1993.

> > > > >

> > > > > 9. Copeland, N. Kressel, A., Spiera, H., Hermann, G and

> > Bleiweiss, I.

> > > > > SYSTEMIC INFLAMMATORY DISORDER RELATED TO FIBROUS BREAST

> > CAPSULES AFTER

> > > > > SILICONE IMPLANT REMOVAL: A CASE REPORT AND REVIEW OF THE

> > LITERATURE.

> > > > Plast.

> > > > > Reconstr. Surg. 92; 1179, 1993.

> > > > >

> > > > > 10. Dunn, K. W. E., Hall, P. N. and Khoo, C. T. K. BREAST

> > IMPLANT

> > > > MATERIALS:

> > > > > SENSE AND SAFETY. Br. J. Plast. Surg. 45: 315, 1992.

> > > > >

> > > > > 11. Brody, G. S. D., Conway, D Shons and Wesiman. CONSENSUS

> > STATEMENT ON

> > > > THE

> > > > > RELATIONS OF BREAST IMPLANTS TO CONNECTIVE-TISSUE DISORDERS.

> > Plast.

> > > > > Reconstr. Surg. 90: 1102, 1992.

> > > > >

> > > > > 12. Lilla, J. A. and Vistnes., L. M. LONG-TERM STUDY OF

> > REACTIONS TO

> > > > VARIOUS

> > > > > SILICONE BREAST IMPLANTS IN RABBITS. Plast. Reconstr. Surg.

57:

> > 637,

> > > 1976.

> > > > >

> > > > > 13. Maxwell, G. P., and Falcone, P. A. EIGHTY-FOUR

CONSECUTIVE

> > BREAST

> > > > > RECONSTRUCTIONS USING A TEXTURED SILICONE TISSUE EXPANDER.

> > Presented at

> > > > the

> > > > > 69th Annual Meeting of the American Association of Plastic

> > Surgeons in

> > > Hot

> > > > > Springs, VA, May, 1990.

> > > > >

> > > > > 14. Vogt, P. A., Seider, H. A., and Moufarege, R. I. SURFACE

> > PATTERNED

> > > > > SILICONE IMPLANTS DECREASE CONTRACTURE FOR SOFT BREAST

> > PROSTHESES.

> > > > Contemp.

> > > > > Surg. 37: 25, 1990.

> > > > >

> > > > > 15. , D. J., Foo, I. T. H., and Sharpe, D. T.

TEXTURED

> > OR SMOOTH

> > > > > IMPLANTS FOR BREAST AUGMENTATION? A PROSPECTIVE CONTROLLED

> > TRIAL. Br. J.

> > > > > Plast. Surg. 44: 444, 1991.

> > > > >

> > > > > 16. Barone, F. E., , L. Keller, T. and Maxwell, G. P.

THE

> > > > BIOMECHANICAL

> > > > > AND HISTOPATHOLOGIC EFFECTS OF TEXTURING WITH SILCIONE AND

> > POLYRETHANE

> > > IN

> > > > > TISSUE IMPLANTATION AND EXPANSION. Plast. Recontr. Surg. 90:

> > 77, 1992.

> > > > >

> > > > > 17. Brohim, R. M. Foresmann, P. A., Hildrebrandt, P. K. and

> > Rodeheaver,

> > > G.

> > > > > T. EARLY TISSUE REACTION TO TEXTURED BREAST IMPLANT

SURFACES.

> > Ann.

> > > Plast.

> > > > > Surg. 28: 354, 1992.

> > > > >

> > > > > 18. Robbins, S. L. Cotran, R. S. and Kumar, V. INFLAMMATION

AND

> > REPAIR.

> > > In

> > > > > Pathologic Basis of Disease, Philadelphia, Saunders, 1984,

> > Pages 61-65.

> > > > >

> > > > > 19. Brody, G. S., and White W. I. NEW CONCEPTS IN PROSTHETIC

> > JOINTS FOR

> > > > USE

> > > > > IN THE HAND. Plast. Reconstr. Surg. 32: 45, 1963.

> > > > >

> > > > > 20. Goldring, S. R., Schiller, A. L., Roelke, M. Rourke, C.

M.,

> > O'Neil,

> > > D.

> > > > > A. and , W. H. THE SYNOVIAL-LIKE MEMBRANE AT THE BONE-

> > CEMENT

> > > > INTERFACE

> > > > > IN LOOSE TOTAL HIP REPLACEMENTS AND IT PROPOSED ROLE IN BONE

> > LYSIS. J.

> > > > Boen

> > > > > Joint Surg. 65A, 575, 1983.

> > > > >

> > > > > 21. Bhawan, J. Dayal, Y., -Serva A., and Eisen, R.

> > CUTANEOUS

> > > > > METAPLASTIC SYNOVIAL CYST. J. Cutan. Pathol. 17: 22, 1990.

> > > > >

> > > > > 22. , J. G., Ghiselli, R. W., and Santa Cruz, D. J.

> > SYNOVIAL

> > > > > METAPLASIA OF THE SKIN. Am. J. Surg. Pathol. 1: 343, 1987.

> > > > >

> > > > > 23. Gomez Dorronsoro, M. L. ez-Penuela, J. M. and

Ruiz de

> > la

> > > > Hermosa,

> > > > > J. METAPLASTIC SYNOVIAL CYST (Letter). Am. J. Surg. Pathol.

12:

> > 649,

> > > 1988.

> > > > >

> > > > > 24. Stern, D. R., and Sexton, F. M. METAPLASTIC SYNOVIAL

CYST

> > AFTER

> > > > PARTIAL

> > > > > EXCISION OF NEVUS SEBACEUS. Am. J. Dermatopathol. 10: 531,

1988.

> > > > >

> > > > > 25. Selye, H. ON THE MECHANISM THROUGH WHICH HYDROCORTISONE

> > AFFECTS THE

> > > > > RESISTANCE OF TISSUES TO INJURY. AN EXPERIMENTAL STUDY WITH

THE

> > > GRANULOMA

> > > > > POUCH TECHNIQUE. J. A. M. A., 152: 1953.

> > > > >

> > > > > 26. , J. C. W., Sedgwick, A. D. and Willoughby, D.

A. THE

> > > FORMATION

> > > > > OF A STRUCTURE WITH THE FEATURES OF SYNOVIAL LINING BY

> > SUBCUTANEIOUS

> > > > > INJECTION OF AIR; AN IN VIVO TISSUE CULTURE SYSTEM. J.

Pathol.

> > 134: 147,

> > > > > 1981.

> > > > >

> > > > > 27. Hunter, J. M., Jaeger, S. H., Matsui, T., and Miyaji,

N. THE

> > > > > PSEUDOSYNOVIAL SHEATH: ITS CHARACTERISTICS AND A PRIMATE

MODEL.

> > J. Hand

> > > > > Surg. 8: 461, 1983.

> > > > >

> > > > > 28. Drachman, D. B., and Sokoloff, L. THE ROLE OF MOVEMENT

IN

> > EMBRYONIC

> > > > > JOINT DEVELOPMENT. Dev. Biol. 14: 401: 1966.

> > > > >

> > > > > 29. , W. D., Balogh, K., and Abraham, J. L. SILICONE

> > GRANULOMAS:

> > > > > REPORT OF THREE CASES AND REVIEW OF THE LITERATURE. Hum.

> > Pathol. 16:

> > > 197,

> > > > > 1985.

> > > > >

> > > > > ============================================================

> > > > > Flowers, food, gifts and more from Flowers USA!

> > > > > Order by 3pm for same day delivery.

> > > > > Click below to find the perfect gift.

> > > > > http://click.topica.com/caaafPza2iT7oa3jrjhf/FlowersUSA

> > > > > ============================================================

> > > > >

> > > > >

> >

==^================================================================

> > > > > This email was sent to: drkolb@m...

> > > > >

> > > > > EASY UNSUBSCRIBE click here: http://topica.com/u/?

a2iT7o.a3jrjh

> > > > > Or send an email to: BreastImplantNews-unsubscribe@t...

> > > > >

> > > > > T O P I C A -- Register now to manage your mail!

> > > > > http://www.topica.com/partner/tag02/register

> > > > >

> >

==^================================================================

> > > > >

> > > >

> >

> >

> >

> >

[Guest guest]

I was replaced with Mentor smooth anterior value. I agree that lots of the

women with problems have McGhan textured. .

----- Original Message -----

From: nikkipep <GP369@...>

< >

Sent: Wednesday, January 23, 2002 1:42 AM

Subject: Re: Fw: Subject Reference: Fw: SILICONE BREAKDOWN

AND CAPSULAR SYNOVIAL METAPLASIA IN

> Dr Kolb, I'm curious, since you replaced your gels with saline, do

> you have textured or smooth? Also do you think there are more

> problems with the Mc Ghans textured? I see a lot of women on here

> seem to have the same brand of Mc Ghans textured 168's. Also it seems

> there are certain years that many women on this forum got implants

> and have problems, could there be a problem with the way the implants

> were made in those years? I'd like to know what implant you used on

> yourself. Thanks Nik

>

>

>

>

>

>

> > > >

> > > > ----- Original Message -----

> > > > From: Dr. Kolb <drkolb@m...>

> > > > Patty <fdp@l...>; <Carina063@h...>

> > > > Sent: Tuesday, January 22, 2002 8:43 AM

> > > > Subject: Fw: Subject Reference: Fw: SILICONE BREAKDOWN AND

> CAPSULAR

> > > SYNOVIAL

> > > > METAPLASIA IN

> > > >

> > > >

> > > > > : This is an article which describes what is well

> known in

> > > silicone

> > > > > biomaterials research. The clinical experience of all

> doctors I

> > > have

> > > > spoken

> > > > > with is that textured implants are much more likely than

> smooth

> > > to cause

> > > > > problems both systemic and local. In 1997 when I had my

> implants

> > > replaced

> > > > > we did not have clinical evidence that smooth saline implants

> > > that were

> > > > not

> > > > > infected were nearly as dangerous as leaking silicone gel

> > > implants. We

> > > > > still do not have this evidence. I have never stated that

> smooth

> > > implants

> > > > > are safe. I am still trying to identify what puts a patient at

> > > risk. All

> > > > > plastic surgeons that you recommend on this board put in

> smooth

> > > saline

> > > > > implants so it is unfair to single me out as you have done in

> the

> > > past.

> > > > You

> > > > > misunderstood what I was saying in the posts. I would again

> ask

> > > you to

> > > > > carefully read what is said before jumping to conclusions. You

> > > are at a

> > > > > higher level of responsibility as a moderator. .

> > > > > ----- Original Message -----

> > > > > From: Martha Murdock & (gigi*) Lawrence <MAM-NSIF@P...>

> > > > > BreastImplantNews <BreastImplantNews@t...>

> > > > > Sent: Tuesday, January 22, 2002 1:05 AM

> > > > > Subject: Subject Reference: Fw: SILICONE BREAKDOWN AND

> CAPSULAR

> > > SYNOVIAL

> > > > > METAPLASIA IN

> > > > >

> > > > >

> > > > > > ============================================================

> > > > > > Debt Worries? Get Relief Now! Free Online Consultation

> > > > > > Get Out of Debt Quickly - No Credit Check!

> > > > > > No More Harassment! Eliminate Interest & Late Charges!

> > > > > >

> > > http://click.topica.com/caaafxja2iT7oa3jrjha/FirstMutualFinancial

> > > > > > ============================================================

> > > > > >

> > > > > >

> > > > > > From: " Myrl Jeffcoat " <myrlj@j...>

> > > > > > Sent: Monday, January 21, 2002 11:40 PM

> > > > > > Subject: SILICONE BREAKDOWN AND CAPSULAR SYNOVIAL

> METAPLASIA IN

> > > > > > TEXTURED-WALL SALINE BREAST PROTHESIS

> > > > > >

> > > > > >

> > > > > > SILICONE BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

> TEXTURED-

> > > WALL

> > > > > SALINE

> > > > > > BREAST PROTHESIS

> > > > > >

> > > > > > http://www.newwomyn.com/nw012i.html

> > > > > >

> > > > > > Authors: Copeland, Choi, Bleiweiss

> > > > > > Source: Plastic & Reconstructive Surg Jnl, October, 1994,

> Vol.:

> > > 94, No.

> > > > 5,

> > > > > > 628-633

> > > > > > Address: Mt. Sinai Medical Center, NY.

> > > > > >

> > > > > > Saline-filled prostheses are currently the only type of

> > > prostheses

> > > > > available

> > > > > > for cosmetic use in the U. S. because of concerns raised

> about

> > > the

> > > > > > possibility of systemic toxicity of silicone-filled

> artificial

> > > mammary

> > > > > > implants. Although the approved implants are saline-filled,

> > > their

> > > > > potential

> > > > > > to release silicone particles from the shells has not been

> > > > systematically

> > > > > > evaluated. We performed microscopic examination of the

> > > pericapsular

> > > > tissue

> > > > > > of 54 patients with textured-surface implants and compared

> > > these with 51

> > > > > > patients with smooth- walled implants over a two year

> period.

> > > > > >

> > > > > > The capsules that had formed around virtually all textured-

> > > surface

> > > > > implants

> > > > > > had silicone fragments present either in extracellular

> spaces,

> > > in

> > > > > vacuolated

> > > > > > histiocytes, or in the form of foreign-body granulomas in

> > > surrounding

> > > > > > fibroadipose tissue but not in capsules associated with

> smooth-

> > > walled

> > > > > > implants. In 87% of samples of pericapsular tissue from

> > > textured saline

> > > > > > implants, the contact surface displayed exuberant reactive

> > > synovial

> > > > > > metaplasia, a histologic pattern not previously described

> with

> > > these

> > > > > > devices.

> > > > > >

> > > > > > Our finding suggest that smooth-walled prostheses are

> > > associated with

> > > > less

> > > > > > silicone fragmentation than textured devices in the peri-

> > > implant tissue

> > > > > > capsules that tend to form around artificial surfaces used

> for

> > > this purp

> > > > > > ostheses have been implicated in connective tissue

> inflammatory

> > > > syndromes

> > > > > > including systemic sclerosis.1-9 The U. S. Food and Drug

> > > Administration

> > > > > > (FDA) curtailed the clinical use of these implants in 1992

> > > because of

> > > > > > questions concerning the safety of silicone contents.10,11

> > > Saline filled

> > > > > > mammary implants also have a silicone shell but are filled

> with

> > > saline

> > > > and

> > > > > > are therefore considered safer, since resorption of an

> > > innocuous fluid

> > > > > would

> > > > > > be expected to occur in the event of rupture or leakage of

> the

> > > > prosthesis.

> > > > > > These are currently the only breast prostheses available for

> > > cosmetic

> > > > use

> > > > > in

> > > > > > the United States. Both smooth walled and textured surface

> > > implants are

> > > > in

> > > > > > widespread clinical use as implants and as tissue expanders.

> > > Many

> > > > surgeons

> > > > > > favor textured implants, which are reportedly less prone to

> > > capsular

> > > > > > contracture and may produce a smoother, softer result.12-17

> > > Textured

> > > > > > prostheses are often selected not only for primary

> mammoplasty

> > > but also

> > > > as

> > > > > a

> > > > > > replacement device for patients who seek removal of silicone

> > > filled

> > > > > > implants.

> > > > > >

> > > > > > To determine the histologic characteristics of capsular

> tissue

> > > excised

> > > > in

> > > > > > association with saline filled breast implant removal, we

> > > reviewed the

> > > > > > surgical specimens of patients undergoing prosthesis

> removal at

> > > the

> > > > Mount

> > > > > > Sinai Medical Center in 1992 and 1993. Although not prone to

> > > spillage of

> > > > > > encased silicone, saline-filled breast implants have a

> silicone

> > > lining.

> > > > > Our

> > > > > > results raise concerns about tissue reaction to the linings

> of

> > > all

> > > > > > artificial prostheses but about textured surface implants in

> > > particular.

> > > > > >

> > > > > > MATERIAL AND METHODS

> > > > > >

> > > > > > One-hundred ninety-one mammary implants were removed at the

> > > Mount Sinai

> > > > > > Medical Center during 1992-1993 from 139 patients. These

> > > implants had

> > > > been

> > > > > > in place for varying periods of time, ranging from 6 weeks

> to

> > > several

> > > > > years.

> > > > > > The implants were removed for a variety of reasons,

> including

> > > staged

> > > > > > reconstruction procedure and patient dissatisfaction with

> size,

> > > shape or

> > > > > > type of implant.

> > > > > >

> > > > > > Surgical pathology specimens of 57 saline filled implants

> (54

> > > patients)

> > > > > > included portions of t fibrous tissue capsules, all of which

> > > were

> > > > examined

> > > > > > histologically. Fifty-four of the saline filled implants

> were

> > > textured

> > > > > > surface prostheses, and the other three were smooth walled

> > > implants.

> > > > > > Forty-nine (91%) of the textured saline implants were McGhan

> > > Biospan

> > > > > tissue

> > > > > > expanders that had been placed under the pectoralis muscle

> for

> > > breast

> > > > > > reconstruction after mastectomy and inflated according to

> the

> > > > > manufacturer's

> > > > > > recommendations and serially expanded over a course of 6 to

> 25

> > > weeks.

> > > > > >

> > > > > > For comparison we examined the 92 peri-implant capsules of

> 51

> > > patients

> > > > > whose

> > > > > > (mostly bilateral) silicone gel implants were removed; 90 of

> > > these were

> > > > > from

> > > > > > smooth walled silicone implants and 2 were textured walled.

> > > Surgical

> > > > > > pathology specimens were prepared with 10% buffered

> formalin,

> > > embedded

> > > > in

> > > > > > paraffin, and stained with hematoxylin and eosin for

> microscopic

> > > > > examination

> > > > > > under direct incident and polarized light. Immuno-

> histochemical

> > > studies

> > > > of

> > > > > > selected areas in two samples were carried out using

> monoclonal

> > > > antibodies

> > > > > > directed against vimentin, desmin (both Biogenex

> Laboratories,

> > > Dublin,

> > > > > > Calif.), antitrypsin, lysozyme, myoglbin (Dako Laboratories,

> > > Inc., Santa

> > > > > > Barbara, Calif.), macrophage marker, myocyte actin HHF-35

> (Enzo

> > > > > > Laboratories, Syosset, NY), cytokeratin (Becton Dickinson

> > > Laboratories,

> > > > > > Inc., Mountain View, Calif.), and another macrophage marker

> (KP-

> > > 1,

> > > > > courtesy

> > > > > > of Dr. Strauchen).

> > > > > >

> > > > > > RESULTS

> > > > > >

> > > > > > Light microscopic examination of the fibrous capsules

> > > associated with 46

> > > > > of

> > > > > > 54 textured walled saline implants revealed large fragments

> of

> > > silicone

> > > > > > within giant cell granulomas. For example, the inner lining

> of

> > > one was

> > > > > > arranged in a pseudopapillary configuration resembling

> synovial

> > > tissue.

> > > > > The

> > > > > > deeper tissue showed foreign-body granulomas containing

> > > fragments of

> > > > > > silicone.

> > > > > >

> > > > > > Hematoxylin and eosin staining left silicone colorless,

> > > refractile to

> > > > > > decreased incident light, and onbirefringent in polarized

> > > light. These

> > > > > > granulomas were found exclusively in tissue deep to the

> capsule

> > > itself

> > > > > > rather than proximate to the prosthetic surface. Silicon in

> > > diameter

> > > > > within

> > > > > > foreign body giant cells. Unlike " gel bleed " silicone, which

> > > usually

> > > > > appears

> > > > > > as diffuse extracellular material or in microvesicular form

> > > within

> > > > > > histiocytes, the silicone associated with textured saline

> > > implants was

> > > > > > entirely intracellular and compact. Many capsular sections

> had

> > > an inner

> > > > > > lining containing wide pseudopapillary formations

> > > histologically nearly

> > > > > > indistinguishable from synovial tissue. High powered view

> of an

> > > area of

> > > > > one,

> > > > > > for example, revealed that the inner surface of the capsule

> is

> > > composed

> > > > of

> > > > > > palisading, uniform epithelioid cells. Silicone was visible

> as

> > > large,

> > > > > > refractile, nonpolarizable fragments contained within

> > > aggregates of

> > > > > > foreign body type giant cells.

> > > > > >

> > > > > > The surface that had been in contact with the prosthesis

> had a

> > > > > discontinuous

> > > > > > layer of epithelioid columnar cells with polarized and

> > > occasionally

> > > > > > palisading nuclei. Beneath this layer, making up the core

> of the

> > > > > > pseudopapillae, was a layer of histiocytes and fibroblasts

> > > associated

> > > > with

> > > > > > dense collagen both perpendicular and parallel to the

> surface.

> > > Deep to

> > > > > this

> > > > > > layer was vascular fibrofatty tissue. This type reaction--

> > > synovial

> > > > > > metaplasia--was found in varying intensity in 47 of the 54

> > > patients with

> > > > > > textured walled saline (87%). One of 47 with synovial

> > > metaplasia was

> > > > > > associated with an MSI implant, which has a brushlike

> textured

> > > silicone

> > > > > > surface, but no silicone fragments were identified in this

> > > case. The

> > > > > > remaining 7 patients had densely fibrous connective tissue

> > > capsules with

> > > > > > little or no cellular reaction at the inner surface; there

> was

> > > wall

> > > > > > calcification in one. Immunohistochemcial studies

> demonstrated

> > > surface

> > > > > > epithelioid cells strongly positive for vimentin and

> negative

> > > for

> > > > > > cytokeratin and all other antigens tested. The underlying

> > > fibroblast and

> > > > > > histiocytes also were positive for vimentin (antigen),

> although

> > > less

> > > > > > intensely and less consistently positive for antitrypsin,

> > > lysozyme,

> > > > > > macrophage marker, and KP-1. Stains for muscle markers

> (desmin,

> > > > myoglobin,

> > > > > > and mycyte actin HHF-35) were negative in all types

> > > > > > of cells. Three were fibrous and generally acellular. No

> > > silicone

> > > > > fragments

> > > > > > were identified in association with this type prosthesis.

> > > > > >

> > > > > > The capsules of 90 specimens obtained from 51 patients with

> > > smooth

> > > > walled

> > > > > > silicone gel implants showed no synovial metaplasia. These

> > > capsules

> > > > almost

> > > > > > uniformly consisted of densely fibrotic tissue, sometimes

> > > calcified,

> > > > > > associated with histologically identifiable silicone in

> small

> > > amounts

> > > > with

> > > > > > intact implants and in larger amounts when the implant had

> > > ruptured.

> > > > > > Silicone was present in extracellular spaces or in

> vacuolated

> > > > histiocytes

> > > > > or

> > > > > > both. Two additional capsules were from double lumen

> implants

> > > that had

> > > > > > silicone on the outside and saline on the inside. The

> > > pericapsular

> > > > tissue

> > > > > > from one of the double lumen implants showed a minor degree

> of

> > > focal

> > > > > > synovial metaplasia. No silicone fragments were identified

> in

> > > > association

> > > > > > with this type of prosthesis.

> > > > > >

> > > > > > DISCUSSION

> > > > > >

> > > > > > The possible association of silicone gel breast implants

> with

> > > certain

> > > > > > connective tissue disease syndromes1-7 prompted the Food and

> > > Drug

> > > > > > Administration to curtail use of these devices in surgical

> > > practice.

> > > > > Saline

> > > > > > filled prostheses and tissue expanders remain available and

> are

> > > widely

> > > > > > viewed as safer, 10,11 even though their walls are composed

> of a

> > > > silicone

> > > > > > elastomer. Textured surface implants are reputed to produce

> > > better

> > > > > cosmetic

> > > > > > results and few complications related to capsular

> contracture

> > > than

> > > > smooth

> > > > > > walled prostheses or expanders, although these observations

> > > have not

> > > > been

> > > > > > adequately tested in randomized trials.12,17 Our findings

> > > demonstrate

> > > > that

> > > > > > saline filled implants may release fragments of silicone

> into

> > > the

> > > > > > surrounding tissues and that textured surface implants may

> be

> > > associated

> > > > > > with synovial metaplasia.

> > > > > >

> > > > > > In 1990, Maxwell and Falcone13 described 84 consecutive

> breast

> > > > > > reconstructions using textured silicone tissue expanders and

> > > reported no

> > > > > > visible silicone particles in the capsules after the

> expanders

> > > were

> > > > > removed.

> > > > > > Barone et al.16 observed, in a rabbit model, that capsules

> > > surrounding

> > > > > > smooth walled prostheses were relatively acellula s.

> Capsules

> > > around

> > > > > > textured implants contained histiocytes, giant cells, and

> > > intracellular

> > > > > > silicone fragments. Although photomicrographs were not

> > > provided, this

> > > > > > reaction seems analogous to the pattern of synovial

> metaplasia

> > > we

> > > > observed

> > > > > > in the majority of our textured implants. Capsular tissue is

> > > > infrequently

> > > > > > excised when saline implants and expanders are removed, and

> > > this account

> > > > > for

> > > > > > the small number of specimens available for analysis. Our

> > > experience has

> > > > > > been, however, that when capsules are removed and

> histologically

> > > > examined,

> > > > > > silicone fragments are a frequent finding.

> > > > > >

> > > > > > Silicone was located within granulomas in fibroadipose

> tissue

> > > deep to

> > > > the

> > > > > > capsular surface, and therefore, the presence of silicone in

> > > the capsule

> > > > > > cannot be explained by mechanical disruption of the

> elastomer

> > > surface

> > > > > during

> > > > > > implant explantation. Furthermore, a granulomatous reaction

> > > takes

> > > > several

> > > > > > days to develop, so fragmentation of silicone during

> > > explantation could

> > > > > not

> > > > > > account for this histologic picture.18 Synovial metaplasia

> > > developed in

> > > > a

> > > > > > number of cases, and it seems reasonable to speculate that

> this

> > > is a

> > > > > > response to the textured surface and not to silicone.

> Indeed,

> > > in one

> > > > > capsule

> > > > > > that formed around a brushlike textured surface MSI saline,

> > > implant, no

> > > > > free

> > > > > > silicone was found, yet there was extensive synovial

> > > metaplasia. None of

> > > > > the

> > > > > > smooth walled saline implants showed capsular silicone

> > > fragments, and

> > > > > > synovial metaplasia was seen focally in only one case.

> > > Examinations of a

> > > > > > larger number of specimens will be necessary to permit

> proper

> > > > conclusions

> > > > > > about the relative safety of smooth versus textured walled

> > > prostheses.

> > > > > > Synovial metaplasia (metaplastic synovial cyst formation)

> is a

> > > tissue

> > > > > > reaction first described in chickens with experimentally

> > > implanted

> > > > > silicone

> > > > > > joints by Brody and White19 and in humans after total hip

> > > replacement by

> > > > > > Goldring et al.20 Synovial membranes were described at bone

> > > cement

> > > > > > interfaces and resembled reactive synovium. Similar

> phenomena

> > > have been

> > > > > > reported in skin and subcutaneous tissue at sites of

> previous

> > > surgery or

> > > > > > trauma.21-26 Immunohistochemical findings were similar to

> those

> > > we

> > > > > observed

> > > > > > with breast implants: positive staining of the epithelioid

> > > cells for

> > > > > > vimentin and inconsistent positivity in underlying cells for

> > > > antitrypsin,

> > > > > > and lysozyme (macrophage markers); KP-1, an additional

> > > macrophage

> > > > marker,

> > > > > > was negative. Epithelial markers (cytokeratin, AE-1,

> > > > > > and EMA) were uniformly negative in all cells. Although by

> no

> > > means

> > > > > > specific, these staining characteristics are typical of

> normal

> > > > > synoviocytes.

> > > > > > We also found negative staining with muscle markers (MCA,

> > > desmin, and

> > > > > > myoglobin), excluding myfibroblastic differentiation.

> > > > > >

> > > > > > A few cases of metaplastic synovial cysts have been

> described

> > > containing

> > > > > > clear, vicious fluid,26 and these suggest that cells may

> have

> > > secretory

> > > > > > functions similar to those of normal synovium. We found such

> > > fluid in

> > > > one

> > > > > > patient between the capsule and the outer surface of a

> textured

> > > saline

> > > > > > implant. We postulate that a secretory mechanism may be

> operant

> > > in

> > > > > textured

> > > > > > surface breast implants and expanders corresponding to the

> > > clinical

> > > > > tendency

> > > > > > to seroma formation, requiring drainage at the time of

> > > implantation.

> > > > > > Although improved cosmetic results reported with textured

> > > implants have

> > > > > been

> > > > > > attributed to better tissue fixation,15-17 they may

> actually be

> > > related

> > > > to

> > > > > > greater movement stimulating synovial evolution.27-28

> > > > > >

> > > > > > The mechanism by which silicone containing prostheses are

> > > sometimes

> > > > > > associated with systemic inflammatory disorders is not

> clear. A

> > > foreign

> > > > > body

> > > > > > histologic reaction to silicone has been described,29 and an

> > > association

> > > > > > between systemic inflammatory syndromes such as systemic

> > > sclerosis and

> > > > > > silicone breast prostheses has been reported.1-8 Large

> amounts

> > > of

> > > > silicone

> > > > > > may not be required for such responses, and we have

> described

> > > persistent

> > > > > > clinical and serologic evidence of immune inflammation even

> when

> > > > > microscopic

> > > > > > quantities of silicone are left in place in a retained

> fibrous

> > > capsule

> > > > > after

> > > > > > removal of silicone filled prostheses. Saline filled

> implants

> > > are often

> > > > > > considered safer than silicone filled implan ar surface of

> > > textured

> > > > > implants

> > > > > > may become incorporated with capsular tissue. This suggests

> > > that in

> > > > > patients

> > > > > > with a history of inflammatory reactions to silicone, smooth

> > > walled

> > > > saline

> > > > > > filled implants may reduce the risk of recurrent problems.

> > > > > >

> > > > > > Copeland, D. M. D., M. D.

> > > > > >

> > > > > > We acknowledge the support of the following colleagues for

> > > providing

> > > > > access

> > > > > > to clinical case material: Jin Chun, M. D., Saul Hoffman, M.

> > > D., Elliott

> > > > > > Rose, M. D., Skolnik, M. D., Carlin Vickery M. D.,

> and

> > > Hubert

> > > > > > Weinberg, M. D. References: Wish to review abstracts of

> any of

> > > these

> > > > > > articles? Most should be available at the following Web

> Site .

> > > Once

> > > > there,

> > > > > > click on " Medline " and then scroll to under the search field

> > > and click

> > > > on

> > > > > > " Advanced Search. " Put in the name of one of the authors

> that

> > > is most

> > > > > > unusual and that has two initials available to input for the

> > > search.

> > > > When

> > > > > > you find the article, click to tab it and then go to the

> bottom

> > > of the

> > > > > page

> > > > > > and click on " Retrieve Articles. "

> > > > > >

> > > > > > HEALTHGATE

> > > > > >

> > > > > > 1. Press, R. I. , Peebles, C. L, Kumagai, Y., Ochs, R. L.

> and

> > > Tan, E. M.

> > > > > > ANTINUCLEAR AUTOANTIBODIES IN WOMEN WITH SILICONE BREAST

> > > IMPLANTS,

> > > > Lancet,

> > > > > > 340, 1304, 1992.

> > > > > >

> > > > > > 2. Varga, J., Schumacher R. and Jimenez, S. A.. SYSTEMIC

> > > SCLEROSIS AFTER

> > > > > > AUGMENTATION MAMMOPLASTY WITH SILICONE IMPLANTS. Ann.

> Intern.

> > > Med., 111:

> > > > > > 377, 1987.

> > > > > >

> > > > > > 3. Spiera, H. SCLERODERMA AFTER SILICONE AUGMENTATION

> > > MAMMOPLASTY,

> > > > > J.A.M.A,

> > > > > > 260: 236, 1988.

> > > > > >

> > > > > > 4. Truong, L. D., Cartwright, Goodman and Woznicki, D.

> SILICONE

> > > > > > LYMPHADENOPATHY ASSOCIATED WITH AUGMENTATION MAMMOPLASTY;

> > > MORPHOLOGIC

> > > > > > FEATURES OF NINE CASES. Am. J. Surg. Pathol. 12: 484, 1988.

> > > > > >

> > > > > > 5. Brody S. C., SCLERODERMA AFTER AUGMENATATION

> MAMMOPLASTY, J.

> > > A. M.

> > > > A.,

> > > > > > 260: 236, 1988.

> > > > > >

> > > > > > 6. Brozena, S., Fenske N., Cruse, W. Espinoza, C., Vasey,

> F. B.,

> > > > Germanin

> > > > > > and Espinoza, L. HUMAN ADJUVANT DISEASE FOLLOWING

> AUGMENTATION

> > > > > MAMMOPLASTY.

> > > > > > Arch. Dermatol. 126, 1198, 1990.

> > > > > >

> > > > > > 7. Sahn, E., Garen, P. Silver, R. and Maize, J. SCLERODERMA

> > > FOLLOWING

> > > > > > AUGMENTATION MAMMOPLASTY. Arch. Dermatol. 126: 1198. 1990.

> > > > > >

> > > > > > 8. Hirmand, H. Latrenta, G. S. and Hoffman. AUTOIMMUNE

> DISEASE

> > > AND

> > > > > SILICONE

> > > > > > BREAST IMPLANTS. Oncology 7: 17, 1993.

> > > > > >

> > > > > > 9. Copeland, N. Kressel, A., Spiera, H., Hermann, G and

> > > Bleiweiss, I.

> > > > > > SYSTEMIC INFLAMMATORY DISORDER RELATED TO FIBROUS BREAST

> > > CAPSULES AFTER

> > > > > > SILICONE IMPLANT REMOVAL: A CASE REPORT AND REVIEW OF THE

> > > LITERATURE.

> > > > > Plast.

> > > > > > Reconstr. Surg. 92; 1179, 1993.

> > > > > >

> > > > > > 10. Dunn, K. W. E., Hall, P. N. and Khoo, C. T. K. BREAST

> > > IMPLANT

> > > > > MATERIALS:

> > > > > > SENSE AND SAFETY. Br. J. Plast. Surg. 45: 315, 1992.

> > > > > >

> > > > > > 11. Brody, G. S. D., Conway, D Shons and Wesiman. CONSENSUS

> > > STATEMENT ON

> > > > > THE

> > > > > > RELATIONS OF BREAST IMPLANTS TO CONNECTIVE-TISSUE DISORDERS.

> > > Plast.

> > > > > > Reconstr. Surg. 90: 1102, 1992.

> > > > > >

> > > > > > 12. Lilla, J. A. and Vistnes., L. M. LONG-TERM STUDY OF

> > > REACTIONS TO

> > > > > VARIOUS

> > > > > > SILICONE BREAST IMPLANTS IN RABBITS. Plast. Reconstr. Surg.

> 57:

> > > 637,

> > > > 1976.

> > > > > >

> > > > > > 13. Maxwell, G. P., and Falcone, P. A. EIGHTY-FOUR

> CONSECUTIVE

> > > BREAST

> > > > > > RECONSTRUCTIONS USING A TEXTURED SILICONE TISSUE EXPANDER.

> > > Presented at

> > > > > the

> > > > > > 69th Annual Meeting of the American Association of Plastic

> > > Surgeons in

> > > > Hot

> > > > > > Springs, VA, May, 1990.

> > > > > >

> > > > > > 14. Vogt, P. A., Seider, H. A., and Moufarege, R. I. SURFACE

> > > PATTERNED

> > > > > > SILICONE IMPLANTS DECREASE CONTRACTURE FOR SOFT BREAST

> > > PROSTHESES.

> > > > > Contemp.

> > > > > > Surg. 37: 25, 1990.

> > > > > >

> > > > > > 15. , D. J., Foo, I. T. H., and Sharpe, D. T.

> TEXTURED

> > > OR SMOOTH

> > > > > > IMPLANTS FOR BREAST AUGMENTATION? A PROSPECTIVE CONTROLLED

> > > TRIAL. Br. J.

> > > > > > Plast. Surg. 44: 444, 1991.

> > > > > >

> > > > > > 16. Barone, F. E., , L. Keller, T. and Maxwell, G. P.

> THE

> > > > > BIOMECHANICAL

> > > > > > AND HISTOPATHOLOGIC EFFECTS OF TEXTURING WITH SILCIONE AND

> > > POLYRETHANE

> > > > IN

> > > > > > TISSUE IMPLANTATION AND EXPANSION. Plast. Recontr. Surg. 90:

> > > 77, 1992.

> > > > > >

> > > > > > 17. Brohim, R. M. Foresmann, P. A., Hildrebrandt, P. K. and

> > > Rodeheaver,

> > > > G.

> > > > > > T. EARLY TISSUE REACTION TO TEXTURED BREAST IMPLANT

> SURFACES.

> > > Ann.

> > > > Plast.

> > > > > > Surg. 28: 354, 1992.

> > > > > >

> > > > > > 18. Robbins, S. L. Cotran, R. S. and Kumar, V. INFLAMMATION

> AND

> > > REPAIR.

> > > > In

> > > > > > Pathologic Basis of Disease, Philadelphia, Saunders, 1984,

> > > Pages 61-65.

> > > > > >

> > > > > > 19. Brody, G. S., and White W. I. NEW CONCEPTS IN PROSTHETIC

> > > JOINTS FOR

> > > > > USE

> > > > > > IN THE HAND. Plast. Reconstr. Surg. 32: 45, 1963.

> > > > > >

> > > > > > 20. Goldring, S. R., Schiller, A. L., Roelke, M. Rourke, C.

> M.,

> > > O'Neil,

> > > > D.

> > > > > > A. and , W. H. THE SYNOVIAL-LIKE MEMBRANE AT THE BONE-

> > > CEMENT

> > > > > INTERFACE

> > > > > > IN LOOSE TOTAL HIP REPLACEMENTS AND IT PROPOSED ROLE IN BONE

> > > LYSIS. J.

> > > > > Boen

> > > > > > Joint Surg. 65A, 575, 1983.

> > > > > >

> > > > > > 21. Bhawan, J. Dayal, Y., -Serva A., and Eisen, R.

> > > CUTANEOUS

> > > > > > METAPLASTIC SYNOVIAL CYST. J. Cutan. Pathol. 17: 22, 1990.

> > > > > >

> > > > > > 22. , J. G., Ghiselli, R. W., and Santa Cruz, D. J.

> > > SYNOVIAL

> > > > > > METAPLASIA OF THE SKIN. Am. J. Surg. Pathol. 1: 343, 1987.

> > > > > >

> > > > > > 23. Gomez Dorronsoro, M. L. ez-Penuela, J. M. and

> Ruiz de

> > > la

> > > > > Hermosa,

> > > > > > J. METAPLASTIC SYNOVIAL CYST (Letter). Am. J. Surg. Pathol.

> 12:

> > > 649,

> > > > 1988.

> > > > > >

> > > > > > 24. Stern, D. R., and Sexton, F. M. METAPLASTIC SYNOVIAL

> CYST

> > > AFTER

> > > > > PARTIAL

> > > > > > EXCISION OF NEVUS SEBACEUS. Am. J. Dermatopathol. 10: 531,

> 1988.

> > > > > >

> > > > > > 25. Selye, H. ON THE MECHANISM THROUGH WHICH HYDROCORTISONE

> > > AFFECTS THE

> > > > > > RESISTANCE OF TISSUES TO INJURY. AN EXPERIMENTAL STUDY WITH

> THE

> > > > GRANULOMA

> > > > > > POUCH TECHNIQUE. J. A. M. A., 152: 1953.

> > > > > >

> > > > > > 26. , J. C. W., Sedgwick, A. D. and Willoughby, D.

> A. THE

> > > > FORMATION

> > > > > > OF A STRUCTURE WITH THE FEATURES OF SYNOVIAL LINING BY

> > > SUBCUTANEIOUS

> > > > > > INJECTION OF AIR; AN IN VIVO TISSUE CULTURE SYSTEM. J.

> Pathol.

> > > 134: 147,

> > > > > > 1981.

> > > > > >

> > > > > > 27. Hunter, J. M., Jaeger, S. H., Matsui, T., and Miyaji,

> N. THE

> > > > > > PSEUDOSYNOVIAL SHEATH: ITS CHARACTERISTICS AND A PRIMATE

> MODEL.

> > > J. Hand

> > > > > > Surg. 8: 461, 1983.

> > > > > >

> > > > > > 28. Drachman, D. B., and Sokoloff, L. THE ROLE OF MOVEMENT

> IN

> > > EMBRYONIC

> > > > > > JOINT DEVELOPMENT. Dev. Biol. 14: 401: 1966.

> > > > > >

> > > > > > 29. , W. D., Balogh, K., and Abraham, J. L. SILICONE

> > > GRANULOMAS:

> > > > > > REPORT OF THREE CASES AND REVIEW OF THE LITERATURE. Hum.

> > > Pathol. 16:

> > > > 197,

> > > > > > 1985.

> > > > > >

> > > > > > ============================================================

> > > > > > Flowers, food, gifts and more from Flowers USA!

> > > > > > Order by 3pm for same day delivery.

> > > > > > Click below to find the perfect gift.

> > > > > > http://click.topica.com/caaafPza2iT7oa3jrjhf/FlowersUSA

> > > > > > ============================================================

> > > > > >

> > > > > >

> > >

> ==^================================================================

> > > > > > This email was sent to: drkolb@m...

> > > > > >

> > > > > > EASY UNSUBSCRIBE click here: http://topica.com/u/?

> a2iT7o.a3jrjh

> > > > > > Or send an email to: BreastImplantNews-unsubscribe@t...

> > > > > >

> > > > > > T O P I C A -- Register now to manage your mail!

> > > > > > http://www.topica.com/partner/tag02/register

> > > > > >

> > >

> ==^================================================================

> > > > > >

> > > > >

> > >

> > >

> > >

> > >

[Guest guest]

Dr. Kolb

If a particular implant was found to be causing an

inordinate number of problems, why wasn't an alert

issued to let the implanted women and their doctors

know of possible problems?

This type of action (or should we say inaction)

results in the public losing faith in the medical

profession. We are sick of being lied to!

Consider the thousands of women whose lives were

seriously impacted by these defective implants.

Rogene

--- " Dr. Kolb " <drkolb@...> wrote:

> I was replaced with Mentor smooth anterior value. I

> agree that lots of the

> women with problems have McGhan textured. .

> ----- Original Message -----

> From: nikkipep <GP369@...>

> < >

> Sent: Wednesday, January 23, 2002 1:42 AM

> Subject: Re: Fw: Subject Reference:

> Fw: SILICONE BREAKDOWN

> AND CAPSULAR SYNOVIAL METAPLASIA IN

>

>

> > Dr Kolb, I'm curious, since you replaced your gels

> with saline, do

> > you have textured or smooth? Also do you think

> there are more

> > problems with the Mc Ghans textured? I see a lot

> of women on here

> > seem to have the same brand of Mc Ghans textured

> 168's. Also it seems

> > there are certain years that many women on this

> forum got implants

> > and have problems, could there be a problem with

> the way the implants

> > were made in those years? I'd like to know what

> implant you used on

> > yourself. Thanks Nik

> >

__________________________________________________

[Guest guest]

Rogene: I have not only written letters to many plastic surgeons but also

ask to speak to implant manufacturers about what I am seeing clinically. So

far no one is interested. I did give a half hour interview with channel 5

TV this week to point out dangers of silicone and saline implants as Emory

is involved in testing the new silicone gel implants. I don't think any

wants to here about these problems. .

----- Original Message -----

From: Rogene S <saxony01@...>

< >

Sent: Thursday, January 24, 2002 10:11 AM

Subject: Re: Re: Fw: Subject Reference: Fw: SILICONE

BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

> Dr. Kolb

>

> If a particular implant was found to be causing an

> inordinate number of problems, why wasn't an alert

> issued to let the implanted women and their doctors

> know of possible problems?

>

> This type of action (or should we say inaction)

> results in the public losing faith in the medical

> profession. We are sick of being lied to!

>

> Consider the thousands of women whose lives were

> seriously impacted by these defective implants.

>

> Rogene

>

>

> --- " Dr. Kolb " <drkolb@...> wrote:

> > I was replaced with Mentor smooth anterior value. I

> > agree that lots of the

> > women with problems have McGhan textured. .

>

> > ----- Original Message -----

> > From: nikkipep <GP369@...>

> > < >

> > Sent: Wednesday, January 23, 2002 1:42 AM

> > Subject: Re: Fw: Subject Reference:

> > Fw: SILICONE BREAKDOWN

> > AND CAPSULAR SYNOVIAL METAPLASIA IN

> >

> >

> > > Dr Kolb, I'm curious, since you replaced your gels

> > with saline, do

> > > you have textured or smooth? Also do you think

> > there are more

> > > problems with the Mc Ghans textured? I see a lot

> > of women on here

> > > seem to have the same brand of Mc Ghans textured

> > 168's. Also it seems

> > > there are certain years that many women on this

> > forum got implants

> > > and have problems, could there be a problem with

> > the way the implants

> > > were made in those years? I'd like to know what

> > implant you used on

> > > yourself. Thanks Nik

> > >

>

>

> __________________________________________________

>

[Guest guest]

Sorry. I don't think anyone wants to hear about these problems. Its two in

the morning and I can't type well. .

----- Original Message -----

From: Dr. Kolb <drkolb@...>

< >

Sent: Friday, January 25, 2002 1:35 AM

Subject: Re: Re: Fw: Subject Reference: Fw: SILICONE

BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

> Rogene: I have not only written letters to many plastic surgeons but also

> ask to speak to implant manufacturers about what I am seeing clinically.

So

> far no one is interested. I did give a half hour interview with channel 5

> TV this week to point out dangers of silicone and saline implants as Emory

> is involved in testing the new silicone gel implants. I don't think any

> wants to here about these problems. .

> ----- Original Message -----

> From: Rogene S <saxony01@...>

> < >

> Sent: Thursday, January 24, 2002 10:11 AM

> Subject: Re: Re: Fw: Subject Reference: Fw: SILICONE

> BREAKDOWN AND CAPSULAR SYNOVIAL METAPLASIA IN

>

>

> > Dr. Kolb

> >

> > If a particular implant was found to be causing an

> > inordinate number of problems, why wasn't an alert

> > issued to let the implanted women and their doctors

> > know of possible problems?

> >

> > This type of action (or should we say inaction)

> > results in the public losing faith in the medical

> > profession. We are sick of being lied to!

> >

> > Consider the thousands of women whose lives were

> > seriously impacted by these defective implants.

> >

> > Rogene

> >

> >

> > --- " Dr. Kolb " <drkolb@...> wrote:

> > > I was replaced with Mentor smooth anterior value. I

> > > agree that lots of the

> > > women with problems have McGhan textured. .

> >

> > > ----- Original Message -----

> > > From: nikkipep <GP369@...>

> > > < >

> > > Sent: Wednesday, January 23, 2002 1:42 AM

> > > Subject: Re: Fw: Subject Reference:

> > > Fw: SILICONE BREAKDOWN

> > > AND CAPSULAR SYNOVIAL METAPLASIA IN

> > >

> > >

> > > > Dr Kolb, I'm curious, since you replaced your gels

> > > with saline, do

> > > > you have textured or smooth? Also do you think

> > > there are more

> > > > problems with the Mc Ghans textured? I see a lot

> > > of women on here

> > > > seem to have the same brand of Mc Ghans textured

> > > 168's. Also it seems

> > > > there are certain years that many women on this

> > > forum got implants

> > > > and have problems, could there be a problem with

> > > the way the implants

> > > > were made in those years? I'd like to know what

> > > implant you used on

> > > > yourself. Thanks Nik

> > > >

> >

> >

> > __________________________________________________

> >

[Guest guest]

Dr. Kolb,

Thanks for an honest reply.

Why is this not a surprize?

As long as the " right " people get what they want, the

women can be dammed.

Rogene

--- " Dr. Kolb " <drkolb@...> wrote:

> Rogene: I have not only written letters to many

> plastic surgeons but also

> ask to speak to implant manufacturers about what I

> am seeing clinically. So

> far no one is interested. I did give a half hour

> interview with channel 5

> TV this week to point out dangers of silicone and

> saline implants as Emory

> is involved in testing the new silicone gel

> implants. I don't think any

> wants to here about these problems. .

__________________________________________________