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.
“My family doctor doesn’t want to hear from me about transvaginal mesh problems,” says Jacquelyn. “He thinks everything is related to my weight, which has been piling on over the years since the TVM surgery—there is just so much you can do when your movements are restricted. He thinks it is also related to anxiety and depression.
"Unfortunately it is hard to find another doctor here. I guess I could demand to have an MRI but why should I have to do that? I think a professional health care provider should be able to connect the dots and order the right tests to determine that this mesh is causing the pain. Every time I cough or sneeze the pain is quite sharp, severe occasionally when I sneeze or cough.
"I didn’t connect the dots until I saw the TV ads about transvaginal mesh lawsuits. That was an eye-opener, realizing so many other women are having the same problems that I am having. I guess my doctor doesn’t watch TV. Nor does he listen very well.
"And sex was an issue. Sometimes it hurt when we had sex so it affected my partner too—I knew he didn’t want to continue. And this TVM sling reduced my ability to be sexually gratified. I know it was both physical and psychological. Then you get to the point of ‘why bother’. And you are left with a scar for no reason. And I gained weight which hung over the adhesion of the scar. I couldn’t exercise because it would aggravate the incontinence symptoms—on an on…”
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“If someone out there is doing revision surgery I would love to sign up,” Jacquelyn adds. “And I am interested in filing a transvaginal mesh claim if it can financially cover any costs for ongoing rehabilitation.
A physiotherapist told me that I can get Urophysio, a very specific type of treatment for urinary and pelvic issues but my health insurance runs out too quickly on other treatment (physio/chiro/massage for skeletal issues). Plus there is time away from work and costs to get there to consider—it all mounts up.”