AMS Transvaginal Mesh Good News and Bad News

Charleston, WVWhen Trudy complained to her doctor about stress urinary incontinence (SUI) after she gave birth to her third child, he advised her to have a simple procedure that would solve any leakage. “He told me that this product was the next best thing to sliced bread so I had the AMS transvaginal mesh implanted and I will never trust doctors again,” says Trudy.

“My incontinence problem got so bad that I had to wear ‘Depends’ every time I left the house,” Trudy explains. “If I coughed or laughed I had no control over my bladder so you can understand why I agreed to have the procedure.” Unfortunately, Trudy had the mesh implanted back in 2005, when complaints to the FDA about the AMS mesh and other mesh (TVM) devices were just trickling in.

Little more than 1,000 TVM complaints were reported to the FDA from 2005 to 2007. As the number of procedures increased, however, so did TVM complications. According to the FDA, three times as many cases were reported in the following two years. In 2010 alone, more than 260,000 women had surgery for SUI, and 80 percent of those women were implanted with transvaginal mesh. And by 2011, the agency concluded that TVMs do not “improve symptomatic results or quality of life” after reviewing reports from 1996 to 2011 to assess how safe and effective the use of TVMs are in pelvic organ prolapse and SUI procedures.

She is correct: Endo Pharmaceuticals, the parent company of AMS, agreed in April 2014 to pay out about $830 million to settle a portion of the thousands of AMS lawsuits involving its mesh product, according to The Wall Street Journal. (Just three years after buying AMS, Endo has put the medical device company up for sale.)

Trudy was implanted with the AMS Sparc Sling, which eroded into bladder tissue and required three surgical attempts to remove it. “From what I understand, the mesh eroded into little bits and migrated to different parts of tissue and some of it is still inside me,” says Trudy. “I have no idea how many more surgeries I will need to get rid of it; I also read online that one woman required more than 20 surgeries to completely remove the mesh and another woman has had multiple surgeries but it can’t all be removed.”

The latter Trudy is referring to is Christine Scott: she was awarded a $5.5 million settlement against Bard’s Avaulta product. The mesh eroded into tissue within her vital pelvic organs, which means that the mesh can never be removed safely.

“Although $5 million seems like a lot of money, it can’t bring back your quality of life,” says Trudy. “I haven’t been able to have sexual intercourse with my partner because it hurts so much, and it hurts him because he can feel a piece of this mesh protruding from my vaginal wall. I’ve been going to a pain management clinic for several years, but that’s like putting a band-aid on a bullet wound. No amount of money will be enough to make me, and countless other women with AMS mesh complications, better again.”