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About The Silicone Shell

Magazine article from American Health, July/August 1994.

SALINE BREAST IMPLANTS MAY NOT BE SO SAFE

Saline-filled breast implants with textured coverings may cause some of the same problems that have been attributed to the notorious silicone variety, a soon-to-be-published study finds.

In 1992 the Food and Drug Administration (FDA) drastically limited the availability of silicone-gel implants due to concerns about rupture, leakage and evidence that silicone may cause autoimmune diseases. So virtually all women desiring implants for breast enlargement or reconstruction were directed to the saline (saltwater-filled) variety.

Both saline and silicone-gel implants have silicone-rubber envelopes that are either smooth or, more recently, textured. Introduced in the early 1980s, textured implants were thought to be more like regular tissue and less likely to provoke a common complication: a tightening of the fibrous capsule the body normally forms around implants, which can make breasts unnaturally hard and painful. But the textured silicone envelopes could be causing problems of their own.

Doctors at Mount Sinai Medical Center in New York City recently removed 27 saline implants and 56 silicone implants from patients and examined the surrounding fibrous capsule (safety concerns have prompted thousands of women to have their implants taken out). Of the 24 saline implants that were textured, 20 had shed silicone fragments into the surrounding tissue; the three smooth implants had not shed. In addition, the fibrous tissue surrounding 18 of the textured saline implants (and one of the smooth ones) contained cells that don't occur naturally in the breast - a sign of a possible autoimmune reaction.

Interestingly, none of the 56 silicone-gel implants - all but two of which were smooth - had shed fragments into surrounding tissue. And none of the smooth ones were associated with abnormal cells, while one of the two textured silicone-gel implants was.

"It's well known that silicone gel can 'bleed' into the surrounding tissue, but we've found that silicone can also enter the body due to fragmentation of the silicone-rubber envelope," says Dr. Copeland, a plastic surgeon at Mount Sinai and a coauthor of the study. "We're concerned that bits of silicone from the textured envelopes or the texturing itself could cause autoimmune and other health problems in some patients."

The FDA announced in January of 1993 that manufacturers of saline implants must prove that the implants are safe enough to stay on the market. But the agency has not yet followed up on its original demand.

- Vreeland

Abstract: Silicone breakdown and capsular synovial meta-plasia in textured-wall saline breast prosthesis.

Author: Copeland, Choi, Bleiweiss

Journal: Plast. Reconstr.Surg.

Journal Volume: 94

Pages: 628-633

Authors address: Mt.Sinai Medical Center, NY

Abstract: Saline-filled prostheses are currently the only type of prostheses available for cosmetic use in the US 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 2-yr. 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 purpose.

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