Mesh Misery: Thousands are suffering. Where are the watchdogs?
If a doctor wants to implant a device into your body, you can be confident that the government has approved the device for that use, right?Photo: Video by kgun9.com
Reporter: Valerie Cavazos
TUCSON (KGUN9-TV) - If a doctor wants to implant a device into your body, you can be confident that the government has approved the device for that use, right?
Ok, then, if the untested device causes problems for thousands of people, you can at least be sure that the government will step in at that point and take action, right?
The product in question seems harmless enough -- mesh devises used to treat a disorder known as pelvic organ prolapse. That’s a common problem women sometimes experience after childbirth, menopause, or weight gain. In fact, more than 350 thousand women undergo surgery for this condition in the U.S. every year. But thousands of those women say the thin material implanted to correct the problem is causing them severe pain and emotional distress. It’s even altering or destroying relationships.
"The stories of these women are very difficult to hear," says attorney Michael McNamara. He's heard complaints from more than 100 southern Arizona women in a span of only a few months. "Really life-altering, relationship altering problems," he said. "It is the most personal of personal injuries that I've seen in over 20 years of doing personal injury work."
The cases are so personal and private that after weeks of trying to find a woman willing to tell her story on camera for this story, not one would step forward. But one social worker who is behind one of the largest nationwide forums devoted to this issue did.
Social worker and founder of TransvaginalHelpline.com Lisa Spitzer says the scenarios she hears are "Horrific. Absolutely horrific, it has destroyed lives, it has destroyed marriages. I just spoke with a gal who can't sit or stand for long periods of time, which is a real problem. They can't work. They're losing their jobs. They're losing their insurance."
To describe what these women are experiencing, picture a cheese grater – brittle and stiff – rubbing hard against the pulp of an orange. That’s similar to what happens when soft tissue rubs against the mesh, and the results can be quite painful. The tissue begins to erode, creating more health problems.
McNamara said, "The product will erode through the tissue back into the vaginal cavity.” That, McNamara said, can lead to more surgery to repair the damage -- often without success. "The tissue is gone and the surgeons are in a very difficult situation in terms of revision surgeries. Women have come to us surgery after surgery and they are left with no real options except live with chronic infections, incontinence, serious pain.”
So why in the world would these mesh products be allowed on the market?
McNamara said, "The first problem was it wasn't properly tested. Basically, the public has been the guinea pig on this." He attributes this to a loophole in the FDA's 510 (K) approval process.
According to a report by the Institute of Medicine, a moderate-risk device that is substantially equivalent to any device previously cleared under that 510(K) process can be cleared for marketing, in an effort to facilitate innovation.
McNamara said, "There's movements afoot with regard to recalls, there's movements afoot with regards to the way the FDA approves these processes."
The FDA is now under pressure from industry experts and lawmakers to change the 510(K) process. A Massachusetts congressman has launched a bill, called the Sound Act, that would let the FDA reject a device if it's been shown to be faulty. "It's not just mesh. We're talking about hip implants, knee implants, etc.," said McNamara.
Many patients report no complications from mesh implants; for those people, the devices work as intended. But between 2008 and 2010, the FDA received more than 1,500 reports of complications with mesh implants, 5 times the rate reported between 2005 and 2007. The FDA responded in July of 2011, ordering new post-market studies with the mesh manufactures and alerting the medical community of the concerns.
9 On Your Side contacted the FDA about those studies.
Mary Beth Ritchey, the FDA’s Associate Director for Post-market Surveillance, responded: "In September, we had a panel meeting and then in January of this year, we sent out orders to begin the process, saying to the companies these are our exact questions that remain open and they need to be addressed."
The FDA is also considering reclassifying these mesh devices from class two to the higher risk class three. Devices in that class must go through clinical trials before approval. Although the FDA has recommended the 33 manufacturers do extensive testing -- for now, the mesh devices will stay on the market. "They are still heavily marketed, heavily used, heavily recommended," said McNamara.
A new Consumer Reports poll shows Americans support stricter safety standards for medical devices. More than eight of 10 people said it was more important to prevent safety problems than it is to encourage innovation.
As things stand now, no immediate solution is on the horizon. Class action lawsuits are pending nationwide, but those could take years to resolve. Experts say that any FDA action also could take years to play out. In the meantime, the devices will remain on the market.