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Vaginal Mesh A womens Story

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

Image: 110722_FDA devices

Ben Sklar for msnbc.com

Janet Holt, a rancher from Floresville, Texas, had a mesh implant placed during a bladder-lift surgery that resulted in seven surgeries to repair the damage. The FDA approved the mesh lining, commonly used for hernias, but has now issued a warning of its complications.
By

 

 

 

msnbc.com contributor
updated 7/26/2011 9:48:19 AM ET

Janet Holt figured she simply had an infection “down there.”

But instead of a prescription, her doctor told her she’d need a procedure. Her bladder had slipped out of place, creating an uncomfortable condition known as pelvic organ prolapse, which affects many women as they age.

Her doctor said he could fix it, building a kind of nest or cradle to prop up her insides. Holt doesn’t remember him ever mentioning that he was going to use something called surgical mesh to do the job. But he was the doctor, so Holt, a 50-year-old from San Antonio, Texas, agreed to the operation.

Four years later, however, 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 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.

“I don’t think I’m going to get any better,” says Holt, now 54, who has had to cut back on work at her family’s five restaurants and can no longer ride horses or play baseball with her young grandson.

Unlike prescription drugs, which must be proven safe and effective before they’re marketed, most medical devices have no such requirement. Only about 10 percent of devices, those deemed the riskiest, such as breast implants and implantable pacemakers, fall into that category. Surgical mesh, used to support organs that have slipped over time, does not.

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