Advocacy group asks FDA to launch criminal investigation of allegedly withheld data on silicone breast implant application

Oct 16 2006

The consumer advocacy group Public Citizen on Thursday sent a letter to acting FDA Commissioner Andrew von Eschenbach asking the agency to conduct a criminal investigation into whether Santa Barbara, Calif.-based Mentor intentionally withheld safety data on its silicone breast implant application, the Washington Post reports.

Most breast implants, which often are given to women who have undergone a mastectomy to treat breast cancer, contain saline solution (Brown, Washington Post, 10/13).

Silicone breast implants were banned in 1992 because of safety concerns, the AP/Chicago Sun-Times reports.

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.

According to the AP/Sun-Times, 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.

"Unless the FDA opens a criminal investigation into Mentor's failure to submit the studies, it will only encourage Mentor and other device manufacturers to selectively send the agency only those studies that put their products in the most favorable light," Sidney Wolfe, director of Public Citizen's Health Research Group, wrote in the letter.

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" (Bridges, AP/Chicago Sun-Times, 10/13).