Succumbing to Political Pressure, FDA May OK Risky Breast Implants

December 3, 2004

by Jan Erickson, Government Relations Director

The U.S Food and Drug Administration (FDA) is under intense political pressure from several breast implant manufacturers and plastic surgeons' groups to quietly approve silicone gel-filled breast implants, even though long-term safety data is lacking.

"Recent disclosures about the FDA's vulnerability to influence from drug manufacturers pressuring them to rush poorly tested prescription medication to market are cause for alarm," said NOW President Kim Gandy. NOW has sent a letter to acting FDA Commissioner Lester M. Crawford, opposing approval at this time for marketing silicone breast implants and urging that the agency release additional company data and an important set of guidelines for breast implant manufacturers.

"Tens of thousands of individuals may have suffered a stroke or heart attack and died as a result of using Vioxx, a popular arthritis drug, while hundreds of thousands of women have been injured and become seriously ill after receiving silicone gel breast implants. It appears that the FDA is in danger of losing its scientific integrity by making decisions that primarily benefit a company's bottom line," Gandy added.

Long History of Implant Problems

Silicone gel-filled breast implants were removed by the FDA from the market in 1992 when it was revealed that they have a high rupture rate and women reported suffering from a multitude of health problems. Only saline or salt water-filled implants remained available for general use, although mastectomy patients have been allowed to get silicone gel-filled implants for breast reconstruction. Over the years, hundreds of thousands of women with silicone breast implants have become ill; some have even died or committed suicide when they could not find relief from their pain and disfigurement.

Leaking and ruptured implants can cause the migration of silicone to other parts of the body, including the lymphatic system, lungs, liver, spleen and brain. Yet few women are aware of the risks of breast implants, especially silicone gel-filled implants. This lack of awareness is due in large part to a disinformation campaign carried on by manufacturers and plastic surgeons that minimizes the risks and distorts scientific data.

Why would they do this? Breast implants are big business: about 250,000 women a year seek breast implants and that number - especially among teen-agers - is growing exponentially. Few women are told about the serious risk when they meet with a plastic surgeon and slick advertising campaigns attempt to convince them that the problems are exaggerated. In recent years, promotion of breast implants in advertisements, magazine articles and on television makeover shows has become intense.

Prospective patients should know that breast implants may interfere with accurate mammography readings, that they may be unable to breast-feed, that little is known about the possible transmission of silicone gel or oil to fetuses and breast-feeding infants, that many insurance companies will not provide health care coverage to women with breast implants and that some restrict coverage; and that all implants (both saline and silicone) will rupture eventually. Repeat surgeries and complications from device rupture (or failure) are unavoidable with the current silicone breast implant devices.

Cancer Risk Increases with Breast Implants

A study conducted by the National Cancer Institute found that women who have had breast implants for at least eight years have twice the normal rate of contracting brain cancer, three times the normal rate for lung cancer, and four times the rate for suicide. A Canadian study found that in complications among women who received silicone breast implants following breast surgery, more than half required a second surgery for their implants. Twenty-three percent required two more surgeries and 17 percent had undergone four or more additional surgeries!

More commonly, breast implant patients report a variety of immune disorders such as rheumatoid arthritis, scleroderma, fibromyalgia, Sjogren's disease and lupus. More research is needed to determine whether implants are associated with or contribute to the development of autoimmune diseases. Strongly suggestive results of a connection come from a 10-year study by the National Institute of Environmental Health Sciences looking at women with and without breast implants who developed myositis, an inflammatory disease of the muscle where there is swelling and muscle loss.

Costly Lawsuits Settled

FDA May Approve Without Adequate Safety Data

Because experience has shown that women with breast implants most often develop health problems following at least 10 to 12 years of implantation, long-term studies should reflect a similar time span. Studies such as those submitted by Inamed Corp., a leading manufacturer of breast implants, usually reflect three years or less of research. An application from another manufacturer, Mentor, reportedly contains only a few years of clinical data.

NOW is concerned that the FDA may reverse a stand taken in January 2004, which delayed approval and asked for more long-term scientific safety data from Inamed. With political pressure from the Bush White House, the agency may proceed with approval without any long-term evidence of safety.

NOW and others submitted suggestions for updated guidelines in April 2004 and were expecting to review the final Guidance Document. The agency had indicated that by updating the guidelines for the breast implant industry, the FDA would more clearly identify the type and amount of scientific data needed to evaluate safety, including important information on rupture, clinical study designs and data, post-approval requirements and labeling.

In August 2004, Inamed submitted additional data to the FDA and is now pressuring the federal agency to approve the implants. The company's additional data has not been made public, nor has the FDA released a Guidance Document which establishes standards for clinical trials on breast implants.

Another type of silicone breast implant called the cohesive silicone breast implant is currently under clinical trial by both Inamed and Mentor. The cohesive silicone implants have a firmer consistency and the manufacturers claim that it is a "rupture free device," but experts in the field believe we will see similar complications as with the gel-filled implants.

Questionable Company Practices

It should be noted that Mentor was under a criminal investigation lasting 10 years - the focus of which included questions about data integrity, good manufacturing practices and quality control. Inamed Corp. has experienced financial ups and downs in recent years and has been aggressively touting stock value increases by suggesting its breast implants may soon be approved.

Critics of the process say that the manufacturers' strategy is to get the FDA to approve these devices with as minimal data as possible and update an informed consent document to include unknown or suspected risks - instead of investigating those risks. Inamed's informed consent for the cohesive silicone breast implant product, for instance, outlines the complications associated with mammography and admits "at this time it is not known if a small amount of silicone may diffuse (pass through) from the silicone-filled breast implant silicone shell and way find its way into breast milk. If this occurs, it is not known what effect it may have on the nursing infant."

The manufacturers also publicly claim that gel migration is not an issue, but buried in the informed consent for the new cohesive silicone implant is the following statement: "both rupture and 'silicone-bleed' may result in the silicone going to other parts of the body. Some medical complications which may occur as a result of these devices are unknown however, they may be long-term effects." Inamed also admits that "one cannot exclude the possibility that some women with breast implants might develop other signs and symptoms related to the immune system that do not conform to 'classic disease descriptions.'"

Says Gandy: "Women's lives and health are at risk because of a secretive, politically-influenced government process. It is absolutely critical for women's health that the FDA provide a public forum for the review of clinical data and all information submitted by both manufacturers."

Note: If you are a breast implant patient and have been experiencing health problems (or if you know of someone who has), please file a statement with the FDA's adverse event reporting program, MedWatch Online.

Also, if you are currently in a clinical trial concerning silicone gel-filled or the cohesive breast implants, please let us know by email.

Send a Message to the FDA: The National Organization for Women urges the FDA to value the health of women over industry profits by demanding long-term safety data before approving breast implant applications from Inamed Corp., Mentor or any other manufacturer. Send a message to officials at the FDA urging them NOT to approve silicone gel-filled implants until the manufacturers fulfill their obligation to meet basic, minimum standards of safety and the FDA can fully document the short- and long-term safety of these devices.