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Ethicon Media Monitoring 09/14/2015
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Relatively Low Risk of Complications With Vaginal Mesh Surgery
Sep 14, 2015 | HealthDay News
Only one out of every 30 women who receive a synthetic vaginal mesh sling to treat stress urinary incontinence will suffer a complication that requires a second surgery, according to a decade-long follow-up study of nearly 60,000 Canadian women. The findings were published online in JAMA Surgery. -
Study Finds Surgical Mesh For Incontinence May Not Be As Dangerous As Previously Believed
Sep 13, 2015 | Pioneer News
By Silvia Fernandez
A new study demonstrates that surgical mesh appears to be safe in the treatment of urinary incontinence in women even though some concern still exists among US regulators. -
Four Years Ago: FDA Where Are You on Pelvic Mesh Proposals?
Sep 11, 2015 | Mesh Medical Device News Desk
By Jane Akre
It’s been four years this past week (September 8, 9, 2011) that the FDA convened a panel of “experts” to form the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.
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Relatively Low Risk of Complications With Vaginal Mesh Surgery
Sep 14, 2015 | HealthDay News
Only one out of every 30 women who receive a synthetic vaginal mesh sling to treat stress urinary incontinence will suffer a complication that requires a second surgery, according to a decade-long follow-up study of nearly 60,000 Canadian women. The findings were published online in JAMA Surgery.
Blayne Welk, M.D., an assistant professor of urology at Western University's Schulich School of Medicine & Dentistry in London, Canada, and colleagues tracked the number of Ontario women who needed a follow-up surgery to remove or repair a mesh implant. The study included 59,887 women who underwent the procedure from April 2002 through December 2012.
Overall, 1,307 women -- or 2.2% -- needed a follow-up surgery within an average of about a year after receiving a mesh implant for stress urinary incontinence, the findings showed. By the end of the decade-long study period, there was a 3.29% cumulative risk of complications, the investigators found. Patients of "low-volume" surgeons were 37% more likely to require a follow-up surgery, when compared with women who received treatment by a surgeon who regularly performs this procedure, the researchers said.
"These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for stress urinary incontinence and that surgeons should achieve expertise in their chosen procedure," the authors write. "Multiple mesh-based procedures for stress urinary incontinence are a novel risk factor associated with an almost 5-fold higher rate of mesh removal or revision, and the safety of this practice should be studied further."
One author disclosed financial ties to Astellas Canada.
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Study Finds Surgical Mesh For Incontinence May Not Be As Dangerous As Previously Believed
Sep 13, 2015 | Pioneer News
By Silvia Fernandez
A new study demonstrates that surgical mesh appears to be safe in the treatment of urinary incontinence in women even though some concern still exists among US regulators.
The study shows that approximately one out of every 30 women who receive a synthetic vaginal mesh sling in the treatment of stress incontinence will suffer some form of complication that might require an additional surgery. This is according a study and follow of 60,000 Canadian over the course of ten years.
“Our study shows that after 10 years of follow-up, one in 30 Ontario women required mesh revision or removal surgery,” explains senior author Dr. Blayne Welk, who is a urologist and adjunct scientist at ICES Western University Schulich School of Medicine & Dentistry.
Welk also comments, “It’s not something where you have to do hundreds of these a year. That translates to one or two per month, which isn’t out of the range of possibility for the average gynecologist or urologist.”
The assistant professor also adds, “If a person has a sling in, 97 percent of them will do just fine and will have a good outcome potentially up to 10 years, in terms of their risk for future surgery.”Still, study co-author Dr. Quoc-Dien Trinh warns that many complications, while not life-threatening, can still affect the quality of life for several patients.
Trinh comments, “This paper shows that there is merit in asking that question specifically in the context of mesh surgeries, and it has been shown to be a generally reliable metric of surgical quality of care. Ultimately, patients need to strike a balance between convenience and quality.”
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Four Years Ago: FDA Where Are You on Pelvic Mesh Proposals?
Sep 11, 2015 | Mesh Medical Device News Desk
By Jane Akre
It’s been four years this past week (September 8, 9, 2011) that the FDA convened a panel of “experts” to form the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.
Their goal was to discuss the five-fold increase in complications associated with pelvic mesh.
The FDA database had received a jump in reports, from mesh erosion, to chronic pain, mesh infections, UTIs, dyspareunia even death. You can read the agenda here. Mesh News Desk was there and covered the story here.
The expert panel convened with a consensus to reclassify mesh used for pelvic organ prolapse to “high risk” or Class III that would require greater scrutiny before it could be marketed such as a Premarket Approval (PMA) and clinical trials on humans. This reclassification proposal applied only to pelvic mesh used for pelvic organ prolapse, (POP) generally a larger piece of polypropylene mesh.
In May 2014 the agency issued two proposed orders filing them in the Federal Register, one to reclassify and the other to require a PMA.
The public comment period was opened for 90 days and concluded at the end of July 2014. See the comments here. Many readers of Mesh News Desk voiced their opinion including hundreds of name gathered by the consumer group Corporate Action Network, which then had joined forces with MND gathered signatures and submitted them electronically.
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