Sens. Feinstein, Snowe ask FDA for safety review of silicone breast implant manufacturer's product application

Oct 24 2006

Sens. Dianne Feinstein (D-Calif.) and Olympia Snowe (D-Maine) on Friday sent a joint letter to acting FDA Commissioner Andrew von Eschenbach asking the agency to launch a full review into whether Santa Barbara, Calif.-based Mentor intentionally withheld safety data on its silicone breast implant application, CQ HealthBeat reports (CQ HealthBeat, 10/23).

Most breast implants, which often are given to women who have undergone a mastectomy to treat breast cancer, contain saline solution. Silicone breast implants were banned in 1992 because of safety concerns.

Mentor and Inamed, which now is part of Allergan, applied to sell silicone implants, and FDA in July and September 2005 gave both applications preliminary approval pending the meeting of certain conditions.

A former employee of Mentor in June last year expressed concerns to Mentor officials that staff had misrepresented, covered up or withheld resilience, leakage and other data on the implants.

The employee was laid off by the company in May, and one month later he contacted FDA with the allegations.

The consumer advocacy group Public Citizen earlier in the month sent a letter to von Eschenbach asking the agency to conduct a criminal investigation into Mentor's product-testing data.

FDA spokesperson Heidi Valetkevich said, "The agency conducted a thorough investigation into these charges and found no evidence of wrongdoing and nothing that would raise questions about the safety of the product under review or the integrity of the data submitted to FDA" (Kaiser Daily Women's Health Policy Report, 10/13).

Feinstein and Snowe in their letter cited allegations that Mentor might have withheld data and some errors regarding leakages from the implants.

The senators asked von Eschenbach to "fully review all data collected by Mentor, whether or not it was originally required.

If the FDA has already investigated these allegations, we request that you share with us the nature and results of this investigation" (CQ HealthBeat, 10/23).