Detroit Free Press
Editorial
May 9, 2005

BREAST IMPLANTS: More information needed before any FDA approval

Companies that want to get silicone breast implants on the market still are not doing a good enough job at working up long-term data that would justify approval by the federal Food and Drug Administration. After an FDA advisory panel split last month -- OK'ing one company's application and nixing another's -- it would be most responsible of the FDA to withhold approval for both and make clear that the companies need to do more and better tracking of implant recipients.

The FDA's own staff report found that roughly three-quarters ofimplants rupture within 10 years,and women who get them need to be aware that they will probablybe returning for replacement sur-gery at least once a decade. And that's assuming other problems don't cause them to return for corrective surgery even sooner. Descriptions of some of the problems, along withother information, can be found at www.fda.gov/cdrh/breastimplants.

Repeat surgeries aside, the risks associated with leaking silicone remain subject to controversy. Other breast implants use a saltwater solution, which the body can absorb if the implant leaks, but women generally prefer the look and feel of the gel-like silicone products to saline ones.

Several studies have discounted any association between siliconeimplants and breast cancer or autoimmune diseases of which some women have complained. But at least one study found statistically significant rates of respiratory cancers in implant patients compared with a control group, along with an increased incidence of brain cancerand suicide that was not as con-clusive.

These are not minor concerns, and they should prompt further investigations with the longest possible look back at the health of women who've had silicone implants.

Last year, the FDA postponed putting silicone implants back on the market, except for in controlled studies, with a request for better data from the companies that want to market the implants. That seemed like an appropriately cautious approach then, and not enough has changed in the meantime to abandon it.