The breast implant brouhaha in France – in which the government is deciding whether to recommend removal of implants in 30,000 women – involves a type of silicone gel implant never used in the United States.
Manufactured by the French company Poly Implant Prothese, or PIP, these contained an industrial-grade silicone and out of the 30,000 surgeries, more than 1,000 have led to ruptures. Fear over possible medical consequences of exposure to the silicone they contain -- as well as a small number of cancers that are not proven to be linked to the implants -- is fueling the concern there.
In this country, silicone gel implants were vilified for years -- and taken off the market for a long spell – out of fears that they were linked to cancers or autoimmune diseases. Though those fears have not panned out, complications are common and a sizable number of women require repeat surgery sooner or later. Buyer beware.
You’ll find masses of information about silicone gel implants at this FDA website including a 2011 update on breast implant safety. It describes the whole story of silicone gel breast implants – which were first introduced to the U.S. back in 1962.
In the 1980s, fears of a link to a cancer or autoimmune diseases led to their removal from the marketplace in 1992, pending more studies on their safety. Only saline implants were available, with a few exceptions, mainly cases of women receiving reconstructive surgery after breast cancer treatment. Those women were studied for any possible negative outcomes.
In 1999, the Institute of Medicine released a detailed report in which they said the only issues they could find with silicone implants were local in nature, such as formation of a hard capsule around the implants. The institute found no evidence of a link to cancer or autoimmune disease.
In 2006, silicone gel implants were back on the market again with the FDA’s approval of two new kinds for general use.
Follow-up studies of those devices show that complications and problems are fairly common, mostly consisting of capsule formation around the implant, rupture, asymmetry, pain, infection and the need for repeat surgery. Among the stats: 20% to 40% of women who had breast enhancement surgery needed a repeat operation in the eight to 10 years after they received the implant. Complications are more common in obese women, according to an October article in the journal Plastic and Reconstructive Surgery.
In addition, implants make mammogram screening more tricky. (See the National Cancer Institute’s recommendations on mammograms for those with breast implants.)
The FDA’s June 2011 conclusion: “Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.”
There is one possible cancer link, but it is far from settled. Very rare cases — only 60 worldwide — of a kind of cancer called Anaplastic Large Cell Lymphoma have been reported in women who have silicone gel breast implants. But it is not yet clear whether those cancers had anything to do with the implants.
In the FDA’s words: “Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL.”
In 2010, 318,123 women in the U.S had breast implants, according to statistics from the American Society for Aesthetic Plastic Surgery, with most choosing silicone gel implants.
For more health news, check out the L.A. Times’ Booster Shots blog.