The FDA conditionally approved Mentor Corp.'s request to sell breast implants earlier this year, only if an undisclosed letter spelling out those specifications were followed. So much for that agreement, based on a letter from a former employee and senior engineer...
Seems the engineer and other Mentor employees resolved a problem with demo implants being distributed for doctors -- they were leaking silicone oil -- for their prospective customers. The big problem: The company never bothered to make the same modification on implants to be fitted for patients, according to a letter to the Washington Post from the former engineer (free text link below).
Moreover, one FDA panel member wasn't pleased to learn during an April meeting that Mentor implants under review might be different than the final product, a huge issue considering more than 300,000 patients in this country underwent breast implant procedures for cosmetic reasons or due to a mastectomy.
Not surprisingly, Mentor officials tried to disparage their former employee, I suspect, to mask the veracity of his claims -- when in doubt blame the messenger. The hanging question here isn't whether silicone implants can be safe, because they can be. But are they safe, particularly when rupturing is a problem?
Washington Post December 5, 2005
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