HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, November 18, 2006

Breast Implants are Back

The FDA announced that is will permit silicone breast implants to be sold again.  According to CNN.Com,

The approved silicone implants are made by two companies, Inamed Aesthetics, now a part of Allergan, and Mentor.

The FDA says these implants are approved "for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older."

Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, told reporters that younger women's breasts continue to develop through their teens and early 20s, and the agency wanted to make sure breast development was completed before women had devices implanted.

In 1992, then-FDA Commissioner Dr. David Kessler took silicone breast implants off the market, citing concerns over their safety, including how often they ruptured in a woman's body and whether leaking silicone could lead to diseases as some women claimed.

After the ban, the implants were available only to women in clinical trials who needed them after surgery, especially after breast cancer. At that point, lawsuits over the products drove one of the manufacturers, Dow Corning, into bankruptcy.

Since then, most studies have failed to link the implants to serious or chronic diseases such as cancer and lupus, but questions remained over how often the implants rupture and what happens if the silicone enters the body. . . .

The consumer advocacy group Public Citizen, which has long opposed silicone implants, criticized the decision and called it "a terrible reminder of the double standard for women versus men" and noted that the FDA has not approved silicone gel testicular implants because of inadequate testing.

More can be found at this site.

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