Safety of Silicone Gel Breast Implants Questioned

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Safety of Silicone Gel Breast Implants Questioned


October 13, 2006
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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www.BreastImplantAwareness.org