Patricia (not her real name) was told that this new device was like the next best thing to sliced bread, and it would treat her incontinence problem by supporting the bladder and urethra like a hammock - no muss, no fuss. But nothing could be further from the truth.
Rather than help her urinary retention problem, the mesh made it horribly worse. To add insult to injury, Patricia’s doctor kept telling her that it would get better, or that she was making a “big deal about a minor issue.” She has since changed doctors.
“I have had nothing but problems since I had the SPARC TVT procedure,” says Patricia.“The vaginal pain and the numerous infections has been something I just learned to live with. Sex is too painful and now I have fecal incontinence. These are just some of the issues I live with daily.”
Patricia is also living with a lot of anger, and justifiably so. American Medical Systems (AMS), the SPARC Sling manufacturer, fast-tracked this mesh device to market by submitting a 510(k) application to the FDA, which allows manufacturers of new devices to avoid rigorous safety studies and clinical trials if the FDA has already approved a “substantially equivalent” device. That equivalent device was the Gynecare TVT (Tension-Free Vaginal Tape) made by Ethicon.
The Gynecare device was also approved by the same “fast-track” process. It too avoided all the safety studies and clinical trials by using the a 510(k) application based on its equivalence to the ProteGen Sling, manufactured by Boston Scientific in 1996. But the ProteGen was recalled in 1999 due to safety concerns - two years before the SPARC Sling was approved! Is it really that difficult for the FDA to connect ProtenGen to Gynecare TVT to the SPARC Sling? Patricia has wondered over and over again, how the hell could this happen?
“I just went out on short-term disability for the second time this year due to the numerous health conditions I have experienced since having this Transvaginal Mesh implanted,” says Patricia. “I’ve been bedridden countless times with the pain, sometimes for days.”
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‘I’m sure I am leaving out many more details that I have learned to live with. I’m hopeful that I’ll be able to tell AMS the details in court, face-to-face, and how they have made my life, and my husband’s life, miserable.”
The SPARC Sling has been linked to high rates of erosion, infection, chronic pain, organ damage and the need for excision surgery. Wait, it gets worse. The FDA in July 2011 said that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP.”