Group seeks FDA probe of breast implants data

Thu Oct 12, 2006 10:58am ET

By Susan Heavey

WASHINGTON (Reuters) - U.S. advocacy group Public Citizen on Thursday called for a criminal investigation into allegations that Mentor Corp. failed to give federal regulators information about potential problems with the company's silicone breast implants.

Mentor Corp. and its rival Inamed Corp., now a unit of Allergan Inc., last year received initial FDA clearance to resume widespread sales of silicone breast implants as long as certain conditions, such as providing additional data, were met first. Final approval is pending.

In a letter to the U.S. Food and Drug Administration, Public Citizen said a former Mentor scientist contacted the FDA in June to alert regulators about safety risk data on leaking gel, toxicity levels and other issues.

The employee, who worked at Mentor for 15 years but did not want his name made public, had urged Mentor to submit the data but the device maker refused, Public Citizen said.

"The fact that they (the studies) were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies," wrote Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Silicone-filled breast implants have been banned for most U.S. women since 1992 amid allegations they can cause long-term health problems.

Public Citizen has been critical of the FDA and has called for a number of drugs and some devices to be pulled from the market.

Public Citizen, in its letter, called on the FDA to postpone a final decision until the additional data were submitted.

Representatives for Mentor and the FDA could not be immediately reached for comment.