The Unregulation of Medical Devices

Many of the medical devices on the market have never been subjected to clinic research or  to thorough scutiny by the FDA.

In the New York Times, is an article that illustrates this problem.  It involves a woman who was surgically treated for urinary incontinence (urine leakage) and had a “vaginal sling” put in her body.

She is now suffering and has sued the manufacturer.

Link:  http://www.nytimes.com/2009/05/05/health/05tape.html?ref=todayspaper&pagewanted=all

“The lawsuits raise new questions about the process by which the F.D.A. reviews new medical devices. While it “approves” drugs, it merely “clears” medical devices with minimal testing if they are deemed “substantially equivalent” to devices already in use.”

The process has been criticized by the agency’s scientists and in a recent Government Accountability Office report concluding that most devices on the market have never been proved safe and effective….

Since then, she has had five operations, each one removing bits of the sling but not the entire thing; another operation is scheduled. She still has chronic discharge and says her sex life with her husband has been affected. She relies on Motrin to get through the day and a sleeping pad to get through the night.

“I feel like I’m never going to be the same again,” Ms. Suriani said, adding: “I’m beginning to feel like this has ruined my life. Not just ruining my life, as in ‘It will get better,’ but ruined, as in ‘I’m stuck with this for the rest of my life.’ I try to stay positive, but it’s getting harder and harder.”

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