Breast Implant Researchers Raised Early Safety Concerns, Paper Says
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NEW YORK — Researchers with Dow Corning Corp. urged safety studies on silicone gel breast implants for more than a decade before they were actually conducted, many of them inadequately, a published report said.
The questionable studies included inserting implants into women before they had been tested in animals, the New York Times said in today’s editions.
The newspaper said the information was contained in documents obtained from several sources it did not name.
In one document, A. H. Rathjen, who headed a task force working on a new implant at Dow Corning, expressed frustration over the lack of data 16 months after the implant was first used. “We are engulfed in unqualified speculation,” Rathjen wrote. “Nothing to date is truly qualitative. Is there something in the implant that migrates out of or off the mammary prosthesis? Yes or no!”
After the implant went on sale in 1975, company officials worried that leaking silicone would make the implants feel greasy, the paper said. Salesmen were subsequently instructed to scrub the implants before showing them to plastic surgeons, the story said.
The Food and Drug Administration last week asked doctors to stop using the implants until safety data can be reviewed. A Dow Corning official said the implants have been properly tested and proved safe.
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