“After the colon cancer I suffered a few bowel obstructions. I had abdominal mesh implanted supposedly to prevent my organs from sticking to the wall of my stomach, but that went horribly wrong,” says 55-year-old Shirley.
Her last surgery—ostensibly to remove the mesh—was five years ago. “My surgeon told me the mesh was impossible to remove because it was stuck to my bowel and had even migrated to my intestines. Next up I went to a pain management clinic: I have this constant aching pulling feeling and sharp pains like someone is kicking at me. It started just above my belly button but now the pain has spread... and I’ve been on oxycontin [the brand name for Oxycodone] since 2015.”
Of course opioids have a whole set of problems. Shirley is suffering from chronic constipation and because the pain is worse when she moves, she has gained weight. “I’ve put on so much weight that I’m as big as a door,” she says. “Before I had this mesh surgery I was in good shape; I used to run and exercise. Now I can barely walk. I rely on my neighbors or Uber to take me to the pain clinic and the grocery store and that’s about as much as I do these days.”
Shirley has kept all her medical reports, including one report that says some of the mesh was cut away from her bowel and intestine, but it didn’t ease the pain. Shirley’s doctor tried sending her to the Mayo Clinic in Jacksonville but they wouldn’t take her because she had too many surgeries. “I asked my doctor why this mesh went so wrong and I don’t think he knows,” says Shirley. “I don’t think the doctors at the Mayo Clinic wanted to mess with it so now I’m stuck.”
A case report similar to Shirley’s, titled “Abdominal Wall Reconstruction with Biologic Mesh following Resection of Locally Advanced Colonic Cancer” found that complication rates were higher when synthetic mesh was used compared with biomesh.
Shirley’s medical report shows that she was implanted with Ventralight Sepra polypropylene mesh made by C.R. Bard, the manufacturer of the Kugel Mesh hernia patch and Avaulta transvaginal mesh, both of which resulted in multi-million dollar settlements (and settlements from a number of manufacturers) to thousands, and thousands of victims have been reported to the FDA for more than a decade.
Transvaginal Mesh and FDA 501K Approval
Transvaginal mesh entered the market via the 501K regulatory review process, which only requires that manufacturers such as Bard need only show their product has "substantial equivalence" to a "predicate device" that has already been legally marketed. No clinical trials are required. Besides, who would want to test vaginal mesh?
A recent FDA executive summary, reported by the Obstetrics and Gynecology Devices Panel in February, 2019, has begun to require human testing for some of these products in an attempt to bring medical devices in line with pharmaceuticals.
The NPR reported that manufacturers say the changes are “reasonable” but they have pushed back against calls to bring regulation of medical devices in line with that of pharmaceuticals. In a November 2018 press release, FDA Commissioner Scott Gottlieb said "We believe firmly in the merits of the 510(k) process… But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices."
READ MORE SURGICAL MESH LEGAL NEWS
“I planned on working until I was 57, which is the mandatory retirement age at federal prisons. Instead I had to retire at 52,” adds Shirley. “I didn’t want to retire and go on disability. I had a good chance of promotion and that would have meant a higher salary and a higher pension. But I couldn’t continue working with the meds. Finally a co-worker advised me to quit before they did a drug test – I could have been fired. She told me that I wasn’t my normal self and it was just a matter of time. They could have messed with me, so in that regard I am fortunate. But only that.”