Women Can't Count on the FDA

The Food and Drug Administration is known worldwide for having the most rigorous safety standards. Unfortunately, it lowered its standard last month when it approved saline-filled silicone breast implants. That decision will have an impact on the lives of as many as 150,000 women and teenage girls who get those implants each year. And if implant makers have their way, the FDA will approve even riskier silicone gel-filled implants next.

To win approval of their saline implants, two Santa Barbara-based corporations presented the FDA with results of their studies of women who got saline implants three to four years ago. They claimed their patients were satisfied, but reported serious problems such as broken implants, breast pain, infection, deformity and additional surgeries to fix those problems.

The manufacturers touted their implants' safety, and they were backed up by plastic surgeons, who told the FDA about the wonderful successes in their practices. Like the children of Garrison Keillor's mythical Lake Wobegon, the surgeons all seemed to be "better than average," with complication rates that were much lower than the research found and patients more enthusiastic about the changes implants made.

Yet analysis by FDA scientists showed that the manufacturers and physicians had underestimated the true rates of complications. Using data gathered by the manufacturers, the FDA calculated that for one manufacturer, Mentor Corp., 43% of women who got implants for augmentation had at least one complication within three years. For mastectomy patients, it was even worse: Within three years, 73% of women who got implants had at least one complication, and 27% had their implants removed. The statistics were even more troubling for the implants made by McGhan Medical. For both brands, the FDA explained that the complication rates were still rising when the studies were completed, so the long-term health risks are unknown.

The FDA also heard heart-wrenching testimony from women with health problems due to saline breast implants. They heard from women who got sick but are too poor because of extensive medical bills to have the implants removed. They heard from women who were denied health insurance because they were considered high-risk due to their implants and subsequent complications. They heard from women whose symptoms did not improve until after their implants were removed. The FDA utterly ignored these devastating stories.