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Ethicon Media Monitoring 10/31/16
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Hernia Mesh Benefits Offset by Long-Term Risks
Oct 28, 2016 | Daily Hornet
Hernia mesh prevented hernias from re-opening and needing another surgery in “relatively few patients,” but caused much higher rates of long-term complications, according to a new study.. -
Transvaginal Mesh Doctors Still in Denial
Oct 29, 2016 | Lawyers And Settlements
By Jane Mundy
Shirley’s doctor in 2012 told her that transvaginal mesh is “new and improved and no larger than a band-aid.” She partially blames her doctor for being duped, but mainly faults the TVM manufacturer for lying to her doctor.
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Hernia Mesh Benefits Offset by Long-Term Risks
Oct 28, 2016 | Daily Hornet
Hernia mesh prevented hernias from re-opening and needing another surgery in “relatively few patients,” but caused much higher rates of long-term complications, according to a new study..
In the United States, over 190,000 people had surgery to repair an incisional hernia in 2012. In at least half of those patients, hernia mesh was stitched into their abdomen to reinforce the abdominal wall.
Some types of hernia mesh have higher risks than others. In May 2016, Ethicon pulled Physiomesh off the market after two large studies in Germany and Denmark found higher rates of hernia recurrence and re-operation.
Because the long-term risks of hernia mesh are unknown, researchers decided to analyze outcomes for 3,242 patients in Denmark who had elective surgery to repair an incisional hernia between 2007 and 2010.
The good news is that hernia mesh appeared to help prevent hernias from recurring and needing another operation. Recurrence occurred in 17% of non-mesh repairs vs. 10-12% of patients who received hernia mesh implants.
Unfortunately, those benefits were offset by increasing rates of devastating mesh-related complications like bowel obstruction, bowel perforation, bleeding, and late abscess — especially in patients with larger-sized mesh.
After 5 years of follow-up, complications were at least 4X more likely in patients who received hernia mesh compared to patients who did not.
Only 0.8% of patients who did not receive hernia mesh developed a long-term complication. In comparison, mesh-related complications occurred after 3.7% of laparoscopic repairs and 5.6% of open repairs.
According to the authors of the study:
"Mesh implantation prevented the need for subsequent re-operation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”
The authors cautioned that the study results may have been skewed by selection bias. Large hernias were more likely to be repaired with mesh, and small hernias with little chance of long-term side effects were more likely to be repaired without mesh.
Source: Dunja Kokotovic, Thue Bisgaard, Frederik Helgstrand. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA, 2016.
https://dailyhornet.com/2016/hernia-mesh-benefits-offset-by-long-term-risks/
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Transvaginal Mesh Doctors Still in Denial
Oct 29, 2016 | Lawyers And Settlements
By Jane Mundy
Las Vegas, NV Shirley’s doctor in 2012 told her that transvaginal mesh is “new and improved and no larger than a band-aid.” She partially blames her doctor for being duped, but mainly faults the TVM manufacturer for lying to her doctor.
“My doctor reassured me that a TVM sling was the way to go and I wouldn’t have any complications,” says Shirley. “I later found out that I had the implant just a few months after the FDA ordered the mesh makers to look more closely at the risks associated with these devices.” And about six months before that, the FDA warned the medical community and the public that transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit. “How could my doctor not have known about the FDA warnings? I’ve been in pain for six years,” says Shirley.
Shirley filed a complaint against the mesh manufacturer because it led her doctor to believe their device was safe. “If I was aware of the FDA warnings, of course I would never have allowed the implant. So my complaint, along with pain and suffering, is that I wasn’t properly warned. And neither was my doctor. Obviously he wouldn’t have advised the mesh to treat my prolapse had he known. He told me that he doesn’t have enough time in the day to read every FDA warning. But he does have time to listen to transvaginal mesh sales reps.”
Almost ten years ago Linda (not her real name) was implanted with a transvaginal mesh bladder sling to treat incontinence. Her urologist sold her on the new “mini sling” that purportedly had less risk of complications and was the “latest in technology”. Less than a week after surgery Linda was in his office, requesting that he take it out.
“He told me not to worry and assured me that the surgery was a success,” says Linda. “I asked him how it could be a success when I am in so much pain. He said the pain wasn’t coming from the mesh but from my gallbladder because I am elderly.” Linda was 55 years old when she had the surgery. She complained to her primary doctor about the mesh but he sided with the urologist. Linda was more than frustrated. She had nowhere to turn because her insurance wouldn’t cover a second opinion by another urologist.“Even if I did see another urologist, chances are they won’t touch another doctor’s work. Nor will they blame another doctor,” says Linda. “I’ve been on long-term disability for years now and thankful for the insurance from my employer. But my urologist still won’t accept the fact that the mesh has caused my disability. He says it’s all in my head, but the pain is real. If and when I get a transvaginal mesh settlement, I won’t be able to collect disability. Just think how much this surgery has cost in disability payments, not to mention ruining my life. Wouldn’t it be more cost-effective for the insurance company to have the mesh removed? But they go by the doctor’s reports, not mine.”
As of November 2014, more than 65,000 transvaginal mesh lawsuits had been filed against a number of manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems and Boston Scientific.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/interview-tvt-sling-transvaginal-mesh-43-21813.html
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