In 1992 the Food and Drug Administration (FDA) took silicone implants off the market because of concerns about the health affects of leaking silicone when the implants burst, which they often did. The manufacturers were not deterred though. From the late 1990's on, they persistently lobbied the FDA to get silicone implants allowed back on the market.
The FDA periodically reviewed available clinical safety data, however analysis of the data wasn't straightforward and the results from all sources; studies, patient's and doctor's testimonies, and silicone manufacturers' testimonies were often contradictory. For instance in 1999 the Institute of Medicine published a literature review of clinical data that although health problems with implants were often recounted by patients and documented in numerous clinical and research studies, they concluded there was no link between health problems and implants. Many were suspicious of this conclusion since there were so many immunological, connective tissue, neurological diseases and systemic complaints, as well as conditions in breast feeding children that seemed be contracted from moms with silicon implants. Some people criticized IOM for considering too much data produced by the manufacturers.
There are passionate advocates for and against silicone implants and each side argues that public opinion, the media, junk science or corporations bias the views' of the other. The truth may hard to sort out but recent evidence reported in Sunday May 22, 2005, The New York Times indicates that the manufacturers who are providing the silicone breast implant safety data to the FDA may not be the most reliable source of the information for evaluating the health affects of implants or potential market suitability.
The FDA is currently reviewing two manufacturers safety data, Mentor's and Inamed's. On April 13, 2005 the an FDA advisory committee voted (7-2) to approve Mentor's breast implants for re-entry in the market, with some conditions. But despite similar results, the same panel voted against Inamed's implants. The FDA committee is being criticized for relying on Mentor's own reports disputed self-reporting of low rupture rates.
The Mentor data is controversial because of other documents recently released to the New York Times. These documents show discrepancies between accounts from Mentor's employees and the records produced by the company at the hearing. The NYT reported that, "In its recent filing with the FDA, Mentor said that it received a total of 8,060 rupture complaints from 1985 to September 2003". However according to the NYT, one of the employees in their deposition, "said that Mentor received about 6,000 complaints of ruptured implants in each of her three years there."
A plaintiff testified a case against Mentor before the Senate in 2002 (HTML version at senate.gov) that as a participant in a post-operative clinical study her health complaints to her surgeon, the manufacturer of the implants and the FDA were ignored. A longer version of the complaints is here.
The plaintiff, whose case was dismissed by the court, just turned over depositions from two former Mentor employees to the NYT. The ex-employees reported, that they had falsified records, that often the silicone was contaminated and sometimes "contaminated with fleas", and that workers sometimes "[hid] defective implant parts above ceiling tiles so managers and inspectors would not realize how often the plant failed to make the parts properly". Why didn't the employees speak out sooner? Reportedly:
[T]op executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products "are in the customers".
As if the leaking, defective, and flea-infested implants weren't enough to dissuade the FDA from allowing them to re-enter the market, a study released in April shows that silicone from implants does enter the lymph nodes. The study, published in the American Journal of Surgical Pathology, reports the pathology of 96 women who had breast plants removed. The results of this study were reported to the FDA on April 12, 2005 according to Public Citizen:
"Although there was evidence of implant rupture in only 47 (49%) of these women, lymph nodes from 86 women (90%) contained droplets consistent with consistent with silicone. A control group consisted of 12 women with breast surgery mainly associated with breast cancer but without silicone gel implants. None of the lymph nodes from these 12 women contained silicone droplets. Similarly, microscopic examination of the lymph nodes revealed abnormal cells, "foamy macrophages," occurring much more frequently in women with silicone gel breast implants than in the control group."
The National Organization of Women is among many groups who weighed in on the matter. NOW sent a a letter (PDF) (PDF!) to Congress questioning the bias of the FDA committee, the Mentor's lack of response to specific toxicity data requests, and the company's skewed clinical trial patient selection protocols.
Despite the allegations of document manipulation, the unsavory clinical evidence, and the FDA's questionable review process, the demand for implants continues to rise. The Institute of Medicine estimated that 1.5 million women had breast implants as of 1997 and 70% of those were cosmetic procedures. The San Francisco Chronicle reported in "Limiting Options for Breast Implants" (May 12, 2005) that many women testified to the FDA in favor of allowing implants in 1992 and in 2003, and last month at the latest hearing. The SF Chronicle reported that the women often reiterated the theme of an American Society of Plastic Surgeons marketing slogan, that breast implants were "A Women's Right to Choose". Co-opting the pro-choice women's rights slogan and recruiting women to chant it on behalf of manufacturing companies who produce silicon implants associated with multiple health risks seems particularly untoward.
