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ParfumGigi@aol.com

30 octobre, 2006 22:01

Concern after a former Mentor employee recently raised doubts about the reliability of data on the performance of Mentor's silicone gel breast implants. ...

SANTA BARBARA, Calif. (AP) — Sen. Dianne Feinstein has called upon the Food and Drug Administration to investigate new claims questioning the data collection methods of Santa Barbara-based medical products company Mentor Corp.

Feinstein, D-San Francisco, and Sen. Olympia Snowe, R-Maine, have sent a letter to acting FDA Commissioner Andrew von Eschenbach that expresses concern after a former Mentor employee recently raised doubts about the reliability of data on the performance of Mentor's silicone gel breast implants.

Similar allegations were raised about 18 months ago.

Mentor and competitor Inamed, which is now part of Allergan, have tried to overturn a 1992 ban on silicone implants which, since then, have been largely restricted to reconstructive post-cancer surgery.

The health concerns that sparked the 14-year restrictions have been the subject of intense research and debate since the issue was brought back to the FDA in October 2003.

Some women have attributed severe health problems to the implants, especially to the effects of silicone leaking into their bodies. Others have testified about the huge benefits from having silicone implants.

Two former Mentor employees have raised concerns about the reliability of some of the research data on which the company is basing its case. The allegations suggest the company deliberately ignored or excluded data that raised questions about the performance of its silicone implants, and may have included results that were less accurate but more favorable to the company.

"We are writing to express our concern about new allegations made by a former Mentor scientist..... If true, it raises serious concerns about the accuracy of the data your agency is using to consider final approval for these implants," Feinstein and Snowe said in the letter.

FDA spokeswoman Heidi Valetkevitch said the agency has conducted an investigation and found no wrongdoing.

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Of course The FDA is going to deny any wrong doing by, Inamed and Mentor Because; they'd have to admit the FDA has been lapse also in collecting the proper data to make an informed decision on the safety of breast Implants too!

A former employee of, Mentor's had nothing to gain by reporting the true

facts concerning the lapse of proper data; Mentor has with held on there faulty Breast Implants. Other than to save other, women and children the misery we've; Been forced to endure by blowing the whistle on Mentor's lies and false data. Any, woman that was in the; Mentor or Inamed study please contact me at

ParfumGigi@aol.com. pass on to your contact list please.

We, can find these, women the proper assistance's.

http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2006/10/29/state/n153511S29.DTL

 


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