Risky Pelvic Mesh Highlights Worries about FDA Process, MSNBC, July 26, 2011

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Risky Pelvic Mesh Highlights Worries about FDA Process, MSNBC, July 26, 2011

Janet Holt and her daughter Stephanie Smith

MSNBC reports on Janet Holt, 54, who underwent surgery for pelvic organ prolapse four years ago, and today reports “the medical device that was supposed to fix Holt’s problem has caused a host of new ones, sparking constant pain and requiring seven more operations as other surgeons tried to remove the mesh, which had eroded into her vagina, bit by bit.”

Holt is not alone. With about 200,000 pelvic operations performed every year in the U.S., there are a growing number of reports of surgical mesh-associated complications in women. Because of the controversy, the FDA issued its second warning about synthetic surgical mesh in less than three years.

“Holt has become a poster child for growing concerns about the government process that allows devices such as surgical mesh — made of the same material as Rubbermaid storage containers — to be used with no testing on patients before they’re allowed on the market.”

Read the rest of the story here.

 

 

By | 2011-07-26T19:21:01+00:00 July 26th, 2011|FDA News, Media Reports, Medical News|0 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

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