Thu, 12 Oct 2006 20:31:43 EDT
MONEYWISE CONSUMER NEWS
Mentor withheld damaging data on breast implants, group says
A former scientist at Mentor Corp. accused the company of withholding unfavorable safety data from regulators considering whether to lift 14-year-old limits on silicone breast implants, a consumer group said.
The Washington-based group Public Citizen is urging the Food and Drug Administration to keep the restrictions and start a criminal investigation. An FDA official told the unidentified whistleblower the data wasn’t requested by the FDA and isn’t relevant, Public Citizen said.
The FDA permits Mentor and Allergan Inc.’s Inamed unit to sell silicone implants for women who lose breasts to cancer or have deformities. The scientist, who worked for Mentor for 15 years, made the allegations after he was “terminated,” the group said.
“This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into Mentor’s failure to promptly send the agency all new information bearing on the safety of silicone gel implants,” said Public Citizen Health Research Group director Sidney M. Wolfe in a letter to the FDA.
The only implants now available to all patients are filled with saline solution because of concerns that the silicone devices ruptured with age and may have caused diseases such as cancer and rheumatoid arthritis.
Gigi-Karen just keep track of what I'm sending on Inamed and Mentor
http://www.kansascity.com/mld/kansascity/business/15741853.htm
