Saturday, October 11, 2003

Breast Implants Mount Comeback

Gina Kolata writes in Saturday's New York Times that the FDA is considering rescinding its ban on silicone breast implants. Inamed Corporation, which wants to sell the implants in the United States, is lobbying for the change, citing numerous studies negating claims that the implants lead to cancer, lupus, and other serious disease.

Lost in that debate, some critics say, is the real risk of other complications. The FDA has a web page devoted to these, complete with photographs that should not be viewed by the timid. Some numbers from the NYT article: Inamed's own two-year study showed 7.5% of its implants had to be removed or replaced. FDA data show a quarter of all implants rupturing within twelve years; 55%, within sixteen.

Let's leave aside women with a legitimate medical need for breast reconstruction, and consider instead the most prevalent use of the implants -- viz., to get bigger breasts. Given the absence of real medical utility in the vanity-implant context, can any device resulting in such a high rate of complications fairly be considered safe? There is no value-free scientific answer to that question, and it may boil down to a political question -- viz., how far we want the FDA to protect consumers from themselves. Ours is a free nation, and we do permit its inhabitants to do many risky and even self-destructive things. On the other hand, the allure of large breasts has been known to overwhelm sound judgment.
Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.