Senators Dianne Feinstein (D-CA) and Olympia Snowe (R-ME) sent a joint letter last week to Andrew von Eschenbach, commissioner of the Food and Drug Administration (FDA), calling for a full investigation of the silicone breast implant maker Mentor. Earlier this month, an anonymous former Mentor scientist alleged that the company had withheld safety information from the FDA during testing, including reports of silicone leakages from the implants into women’s bodies.
The letter focuses on the accuracy of the data the FDA is using for its approval of the breast implants. The Senators urged the FDA to reconsider its approval of Mentor’s product, writing, “No medical device should be granted final approval if data that could reveal potential dangers has not been fully investigated and analyzed. The health and safety of American women should be the top concern of your agency as the approval process moves forward.”