Consumer Law

New Twist on FDA?s Inept Approval Process Of Special Concern to Women

By Joe Consumer

Medical devices that mutilate women are certainly nothing new.  Heck, the Center for Justice & Democracy wrote a whole report on the topic.  But as much as this topic has been covered, there?s always something new and even more dreadful, it seems.

The New York Time?s popular Science section had a disturbing story today about a urinary incontinence device for women, a vaginal sling called ObTape. 

Yes, this device has caused devastating injuries for hundreds if not thousands of women.  Nothing new there.  One woman said she is now dealing with ?a persistent, painful and often bloody vaginal discharge? because the sling had ?started working its way through her vaginal wall? and it?s still not fixed after ?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.? 

Yes, the Food and Drug Administration ?approved? this dangerous device.  Nothing new there either.  The FDA apparently approves unsafe devices all the time with little testing.  As the Times describes it, ?While it ?approves? drugs, it merely ?clears? medical devices with minimal testing if they are deemed ?substantially equivalent? to devices already in use.?

But it turns out, the FDA approved this device based on it being ?substantially equivalent? to a sling that had already been recalled!  And it?s not like the FDA feels it made a mistake.  The agency told the Times in an email that, ?Any legally marketed device can serve as a predicate for a premarket submission.?  Even if it?s been recalled!  Wow, that is a new one.

As the Times also notes, we wouldn?t know about this but for Public Citizen?s Health Research Group, and the injured women (and their attorneys) who have now sued the company. 

Full post as published by ThePopTort on May 05, 2009 (boomark / email).