Law News for You Reality TVM: Mesh Implant Victims\' Stories - Page 10

mesh

THE PAIN AND COST OF

September 28, 2012, 10:30:00AM. By Jane Mundy

Calgary, AB: Jacquelyn had TVM surgery for SUI back in the 1990s, before TV ads about TVM side effects and lawsuits. Now she is in the process of getting her medical records.

Jacquelyn isn’t certain that she had the American Medical Systems (AMS) sling but she says that brand sounds familiar. She does remember the doctor telling her that she was getting a transvaginal mesh sling procedure. AMS makes a few sling systems to treat female stress urinary incontinence or SUI, namely the Sparc Sling System, the Monarc Subfascial Hammock and the MiniArc Sling.

These devices were approved under the FDA’s 501 (k) approval process, which bypasses rigorous testing methods and clinical trials because the manufacturers can show that the device is “substantially equivalent” to other devices currently on the market. Like countless women who have been implanted with TVM, Jacquelyn didn’t know that this device did not need to undergo a standard safety review. Like countless women, she is upset with this knowledge, to say the least.

“I was only 28 when I had this TVM surgery,” says Jacquelyn. “I had two toddlers and couldn’t keep up with them because I had so much leakage. But I still had SUI after the surgery, even while I was recovering in the hospital.”

The TVM surgery created even more problems for Jacquelyn. She started to restrict her fluids to help manage SUI, but she was dehydrated all the time. That led to cramping and other problems. She even tried a course of oral medications that reduces the urgency to urinate. “But when I took those meds I would almost overflow because I didn’t realize I needed to go, so I was back in the same boat,” she explains.

Jacquelyn spent the next few years in a lot of discomfort and pain. She had a low abdominal ache that wouldn’t go away. Then in 2008 she had a procedure using transobturator tape, which is a much less invasive procedure (Jacquie says it only required three stitches) than the TVM sling and it cured her incontinence—finally.

(Transobturator tape is also known as Uratape. In one study it had more than a 90 percent success rate with a one-year follow-up for the treatment of female stress urinary incontinence. The transobturator approach avoids the risk of bladder, bowel or vascular injuries.)

But this second procedure didn’t cure the pain. Jacquie believes the mesh has either moved or eroded.