National NOW Times >> Winter 05-06  >> Article

FDA Makes Another Bad Decision on Silicone Breast Implants

By Jan Erickson, Director of NOW Foundation Programs

In September, the Food and Drug Administration (FDA) issued an "approvable" letter to Inamed Corp. to market its silicone gel-filled breast implants; the action followed an earlier approvable letter issued to Mentor Corp., a second manufacturer applying to sell its implants.

Despite the FDA's actions, there is sufficient evidence to demonstrate that implants — particularly silicone gel-filled implants — pose a serious health threat to women. Silicone contains toxic components, such as platinum, and silicone particles are known to leak from implants and migrate to major organs. Government studies have found higher rates of brain tumors, lung diseases and suicide in women with implants.

Both "approvable" letters stipulated that the companies needed to follow certain conditions when making their implants available to the general public. Though the conditions were not revealed in the letter, it was assumed that the FDA would urge the manufacturers to strongly recommend implant patients seek frequent MRIs to detect possible ruptures and post-operative monitoring. But the FDA has limited authority and oversight to make sure the companies comply, and patients who are still paying off the cost of the implant surgery are unlikely to be able to afford expensive MRIs and other tests.

Both Inamed and Mentor have poor records on monitoring and assisting implant patients, but nevertheless they have put a great deal of effort into publicizing their receipt of the approvable letters in an effort to drive up stock values.

According to reported studies, many implants rupture or begin leaking within seven to ten years and nearly all implants fail within roughly 17 years — although reportedly some cosmetic surgeons tell patients that implants will last a lifetime. Insurance coverage is often either limited or denied to women with implants, including health insurance and disability insurance.

In addition to the fact that neither company has demonstrated long term safety of their implants, as the FDA requested, there is evidence that at least one of the companies excluded hundreds of women who were part of the clinical trials from their clinical study data — presumably because many of these women were experiencing problems. Such problems include rupture, slow leakage, capsular contracture (where painful calcium deposits accumulate and harden around the breast), local and regional infections, migration of the implant or the silicone gel, and the occurrence of auto-immune diseases.

What is even more appalling is the fact that scant data was submitted to the FDA about the effects of implants on women who have had breast cancer. Mentor supplied no data and Inamed evaluated only a few mastectomy patients; complications among breast reconstruction patients are very high, according to a recent study.

The National Organization for Women and more than a dozen allied organizations objected to the issuance of the "approvable" letters, with NOW calling for a withdrawal of the letters.

NOW also filed a Freedom of Information request to the FDA for information about the criminal investigation of Mentor Corp., which was accused by former employees of falsifying data to conceal defective implants. A Senate committee is reportedly investigating the company.

The FDA's willingness to bow to political and industry pressure is now very apparent, and it no doubt played a role in these bad decisions by the agency.

NOW President Kim Gandy recently criticized the FDA's heavy reliance on industry data which are often biased and misleading, adding, "The FDA’s continued contempt for women's health is astounding."