Whistleblower Calls Attention to Safety Issue with Silicone Breast Implants Under FDA Review

By Christine Cupaiuolo — October 19, 2006

The consumer advocacy group Public Citizen last week called for a criminal investigation into why Mentor Corp. didn’t send all its data about safety issues with new silicone breast implants to the Food and Drug Administration. David Brown of the Washington Post writes:

In a letter to the FDA’s administrator, Public Citizen said it learned of test results — some new, some reinterpreted — from a scientist at implant maker Mentor Corp. who says he could not persuade his bosses to forward the data to the regulatory agency.

The scientist had worked for 15 years for Mentor, which is based in Santa Barbara, Calif. He was let go earlier this year in a company reorganization, although he thinks his protests to superiors were part of the reason.

The FDA is in the late stage of reviewing applications by two companies to sell once more silicone breast implants for general use. Last year, the agency gave preliminary approval for the devices on condition that Mentor and a competitor, Inamed (now part of another company, Allergan), complete required tests.

Currently, most breast implants used in the United States are filled with saline solution — salt water. Silicone implants can be used only under limited conditions, generally in FDA-approved studies at specified hospitals.

Many implants are used by women who have had a mastectomy for breast cancer, but most of the 250,000 sold each year are for breast enhancement. That number is expected to rise if the more popular silicone implants are allowed back on the market.

Seriously, Tara Reid should be ordered to do PSAs.

But I digress. For the record, Mentor released a statement that read in part: “During July, representatives from FDA visited our Santa Barbara facility. They asked questions and reviewed documents specific to our preclinical testing. To our knowledge, all questions were answered to the satisfaction of FDA.”

But Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a letter to FDA Acting Commissioner Andrew von Eschenbach: “This new information is compelling enough to warrant a reassessment of FDA’s position. At the very least it should clearly stop any FDA final approval of either device until the withheld data has been submitted, evaluated by the FDA staff, and made available to the public. This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into the Mentor’s failure to promptly send the agency all new information bearing on the safety of silicone gel implants.”

Public Citizen’s letter to the FDA and the whistleblower’s letter to the FDA are available here.

Our Bodies Ourselves, the National Women’s Health Network, and the National Research Center for Women & Families urge people to write to the FDA and insist that silicone gel implants not be approved for general use until serious safety concerns have been addressed.

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