Defective Surgical Material Ruins Lives - Another FDA Failure

A year ago I told you the story of Angela who had recently joined a large group of women suing Mentor Corporation, makers of Mentor OB Tape, for ruining their lives.

Each of them suffered from stress incontinence and sought help to relieve it. Each chose what was supposed to be a relatively simple surgical repair, implanting a sling made of the Mentor OB tape.

However, far from being a simple repair, the tape has instead caused a lifetime of problems for thousands of women. The mesh-like tape disintegrates into small pieces, then migrates to different parts of the body, causing pain, bleeding and malaise. Each woman has required subsequent surgeries to remove those pieces of mesh. Angela (whose real name is Amber) has already had five surgeries and is scheduled for yet another one. It may, or may not, be her last.

Now the story has made the headlines. Amber and others are featured in a New York Times story about Mentor OB tape and the FDA's feeble clearance system which allows such materials to be marketed without showing they work, or are safe. Devices and materials don't have to go through an approval system like drugs do. All they have to show is that they are one more iteration of something else already being used.

In the case of Mentor ObTape, it seems Mentor received clearance to sell its faulty tape by claiming it was just like two other kinds of tape already cleared. One was Johnson & Johnson’s Tension Free Vaginal Tape System. The other was American Medical Systems’ Sparc Sling System. And those tapes had also been cleared by the same process -- they claimed they were just like an even earlier product.

However, the Johnson and Johnson tape had been removed from the market by the FDA in 1999. The FDA then described the tape as "adulterated and misbranded."

So let's get this straight - the Mentor ObTape was cleared for use based on the existence of a tape that had been recalled from the market? That would be like a new pain drug being approved based on the approval of Vioxx, which was withdrawn from the market after thousands of people died from its use. Seriously.

The FDA just can't get its act together. While I understand the roots of that problem (not enough money, and half their budget coming from the pharmaceutical and device companies that they are supposed to regulate) I don't believe those excuses should translate to bad policies, too. But they do.

This kind of story is a major wake up call for us patients, too. Just like we need to ask our doctors, then research the drugs we are prescribed, it looks like we need to do the same for the devices and materials that may be left behind in our bodies from surgeries. From stents to hips and knees to pacemakers -- and slings.

If you will have a surgery that requires a device or material be left behind in your body, ask your doctor for the brand and any product numbers that go with it -- then do your homework. If you have concerns, be sure to raise the question and have the conversation.

If the FDA and our doctors won't protect us, who will? We can't trust them. We have to do it ourselves.

Want to know more? See what Amber has to say.

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