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Safety of Silicone Gel Breast Implants Questioned

October 13, 2006

Breast Implants • FDA's Breast Implant Decision Shows 'Double Standard,' Critics Charge • Safety of Silicone Gel Breast Implants Questioned • FDA Gets Conflicting Recommendations on Silicone Breast Implants • FDA Opens Breast Implant Review

Public Citizen today called for a criminal investigation into Mentor Corporation's apparent failure to send the Food and Drug Administration (FDA) data showing safety problems with their silicone gel implants.

The consumer advocacy organization also called on the FDA to wait until it has reviewed all available safety data before deciding whether to approve the implants.

On June 22, a former scientist from Mentor -- one of the two companies seeking FDA approval of silicone gel breast implants -- sent a letter to the FDA accusing the company of withholding from the FDA a variety of important new safety information.

Prior to sending the letter, the scientist had raised all of the serious concerns documented in the letter within the company, urging Mentor to submit the data, but it allegedly refused and fired the scientist.

An FDA staffer who received the letter told the former Mentor scientist that since the withheld test data were not required in FDA's request to Mentor for more studies, and since the submitted data from both Mentor and Inamed (another silicone gel breast implant manufacturer) were similar, he had no other comment on the new information, implying that the agency would take no action.

"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," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, who today sent a letter to the FDA calling for an investigation.

The former Mentor scientist told the FDA that data about the diffusion of chemicals from the implant into the body were invalid and had been fraudulently represented.

Other data he referred to understated the magnitude of weakening of the implant shell after implantation, which is relevant to its rupture. Still other data showed that as the distance from the front of the implant to the back increased, the estimated lifetime of the device decreased.

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