News this month
FDA panel advises end of silicone breast implant ban
An advisory panel to the Federal Drug Administration (FDA) voted to recommend lifting the 11-year old ban on silicone breast implants. The FDA is not
bound by the decision, but the agency often follows the recommendations of its advisory panels. The panel voted 9-6 in favor of the implants. The FDA has
announced no timeline for its decision.
In its recommendation, the panel said that certain conditions must be met including the reeducation of doctors and patients and the monitoring of women who receive silicone implants. The monitoring would have to be overseen by an outside group and any research conducted on the safety of the devices would have to continue for as long as ten years.
A majority of panel members agreed with Inamed, the silicone implant manufacturer, that it is unfair to continue to ban the silicone implants when they have not been proven to cause any more problems than saline implants, which have remained on the market. Concerns about potential health risks associated with silicone implants prompted the ban in 1992. Since then, only women who have undergone mastectomies—the removal of the breast due to diseases such as cancer—or take part in clinical studies can use silicone implants. Saline implants are the alternative. Some users claim that the saline devices are not as natural in appearance or texture.
Silicone implants were first introduced in the early 1 960s. In the late 1 980s and early 1990s, some reports emerged of implant patients with serious complications, including connective tissue and autoimmune diseases such as arthritis and lupus, chronic fatigue syndrome and cancer.
The FDA ban and subsequent lawsuits against the four companies that manufactured the gel implants resulted in millions of dollars in settlements to the women. One company, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle the claims against it.
What the research shows
Studies by the Mayo Clinic, Harvard Medical School and, in 1999, the Institute of Medicine (IOM) panel from the National Academy of Sciences found no evidence that leaked silicone from gel implants causes systemic disease, although they did report localized problems of pain and the potential for scarring at the site of the implant.
In 1999, the IOM issued a report that addressed several areas of major concern. They found that:
- Silicone implants do not cause breast cancer or reoccurrence of breast cancer.
- There is no evidence that silicone implants contribute to an increase in systemic diseases.
- It is safe to breastfeed infants. In fact, cows’ milk contains much higher levels of silicon, from which silicone is derived, than the breast milk of women with silicone implants.
- Implants do not interfere with radiation therapy.
- No studies have shown that women with implants experience increases in cancer deaths because of mammographic diagnostic difficulties; however, implants can pose imaging challenges for inexperienced technicians.
- The primary problem with implants are local, but not life-threatening complications, including ruptures, deflations, capsular contracture, infection and pain.
- Implants do not last forever; risks accumulate over time, and many women should expect to have more than one implant.
What the news means to you
Assessing the relative risks of breast implants.
Deborah Pan, M.D.
None of the studies conducted by scientists has ever showed any causal relationship between silicone breast implants and systemic autoimmune disease. A small percentage of women will develop these serious diseases; some of them will have implants and some will not. At this point, however, we have no reason to believe silicone is the culprit.
What we do know is there has been a<