Preview Newsletter
Ethicon Media Monitoring 08/03/16
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Australia Wants You to Report Your Mesh Adverse Events
Aug 2, 2016 | Mesh Medical Device Newsdesk
As part of its ongoing monitoring of the safety of urogynaecological surgical meshes, the TGA is urging consumers and health professionals to report any adverse events experienced in association with these medical devices. -
Transvaginal Mesh POP v SUI Warning
Aug 2, 2016 | Lawyers and Settlements
By Jane Mundy
Margot has undergone three surgeries in an attempt to remove AMS transvaginal mesh she had implanted for stress urinary incontinence (SUI). She is outraged that the FDA reclassified transvaginal mesh as high risk only to repair pelvic organ prolapse (POP). -
Mesh Surgery for Anterior Vaginal Wall Prolapse: A Meta-analysis.
Aug 2, 2016 | Uro Today
Pelvic organ prolapse (POP) is a major health issue worldwide, affecting 6-8% of women. The most affected site is the anterior vaginal wall. Multiple procedures and surgical techniques have been used, with or without the use of vaginal meshes, due to common treatment failure, reoperations, and complication rates in some studies.
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Australia Wants You to Report Your Mesh Adverse Events
Aug 2, 2016 | Mesh Medical Device Newsdesk
The TGA (Therapeutic Goods Administration) is the Australian version of our U.S. Food and Drug Administration. The following notice was posted by the government today.
TGA urges reporting of adverse events
2 August 2016
As part of its ongoing monitoring of the safety of urogynaecological surgical meshes, the TGA is urging consumers and health professionals to report any adverse events experienced in association with these medical devices.
The TGA believes that adverse events involving these devices are most likely under-reported and that some patients may not realise that their symptoms are associated with an adverse event.
Urogynaecological meshes (sometimes known as transvaginal meshes and supplied in a variety of forms including ‘sling’, ‘tape’, ‘ribbon’, ‘mesh’ and ‘hammock’) are used to treat a variety of conditions affecting women – most commonly pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs – including the bladder, rectum and uterus – drop into the vagina.
The TGA has been monitoring surgical meshes since 2008 and has continued to publish information for the public and health professionals.
From July 2012 to 1 June 2016, the TGA received 99 adverse events reports involving urogynaecological surgical meshes. The most frequently reported adverse events were pain and erosion.
Reports by consumers and health professionals to the TGA provide important information, building a picture of the safety profile of a product and assisting with our safety monitoring program. A list of adverse events associated with urogynaecological meshes is published in the ‘Additional information’ section below.
Consumers and health professionals are encouraged to report problems with medical devices. The most convenient method for most people to report is via the TGA’s online form(link is external). A hard-copy form can also be downloaded. Further information on what to report and how we use these reports can be found on the TGA’s Incident Reporting and Investigation Scheme (IRIS) webpage.
http://www.meshmedicaldevicenewsdesk.com/australia-wants-report-mesh-adverse-events/
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Transvaginal Mesh POP v SUI Warning
Aug 2, 2016 | Lawyers and Settlements
By Jane Mundy
Dallas, TX Margot has undergone three surgeries in an attempt to remove AMS transvaginal mesh she had implanted for stress urinary incontinence (SUI). She is outraged that the FDA reclassified transvaginal mesh as high risk only to repair pelvic organ prolapse (POP). And she is worried that her transvaginal mesh lawsuit may be delayed or reduced because of this action.
In 2008 the FDA’s mesh warning said complications were “rare”. The agency in 2011 upgraded its warning after receiving 2,874 adverse event reports - 1,503 were associated with POP repairs, and 1,371 were associated with SUI repairs. As of January 2016 transvaginal mesh to repair POP was reclassified from class II (moderate-risk) to class III (high-risk). The FDA has given manufacturers of surgical mesh, including American Medical Systems, 30 months to demonstrate their products are safe and effective for POP by way of a Premarket Approval application.
Darlene (not her real name pending her AMS settlement) had an AMS mesh sling implanted for SUI after the 2011 warning. She is on a waiting list for transvaginal mesh removal. “I am only 49 years old but I’m like a 90-year-old incontinent woman,” she says. “Sex has become incredibly painful and I don’t even know if I will ever enjoy relations with my partner after I get the mesh removed. I have learned online from other women that mesh erosion damage is irreparable. I consider myself lucky, however, that I am not in as poor shape as others.” By others, Darlene is referring to women who were told their SUI problems would be a thing of the past with a transvaginal sling implant but they would rather live with incontinence than the mesh.
Three years ago Linda had an AMS sling implanted for urinary incontinence. “Right away I had bladder problems along with spasms and severe pain,” she said. And her SUI has worsened. Mary also had an AMS mesh product implanted, with a similar outcome. Within weeks, Mary was looking for a surgeon to remove it. “My doctor has done whatever he can to avoid this issue, to the point that he has told me it is ‘all in my head,’ and ‘there is nothing wrong’ and ‘I should give it some time,’ ” Mary said. “He is so wrong… What a mess this mesh turned out to be.”Despite more than 87,000 transvaginal mesh lawsuits filed in the US - making it the largest mass tort action in history - transvaginal mesh to treat SUI is still being advertised in medical centers nationwide. For instance, according to Dr. Jonathan Zaidan, MD, founder and practitioner at Women's Excellence in Bladder Control, "The urethral sling procedure has exceptional, immediate results compared with pelvic floor strengthening. We always like to trial pelvic floor physical therapy first, but if results aren't satisfactory, the TOT sling is the gold standard in treating SUI".
Results have been far from satisfactory for Margot, Darlene, Mary and countless other transvaginal mesh victims. It is unclear why the FDA has added warnings to treat POP and not SUI. Transvaginal mesh slings for SUI and POP are made with the same polypropylene material and they are implanted in the pelvic areas. (LawyersandSettlements hopes to have answers soon.)https://www.lawyersandsettlements.com/articles/ams-transvaginal-mesh/interview-ams-transvaginal-mesh-lawsuit-35-21641.html?utm_expid=3607522-13.Y4u1ixZNSt6o8v_5N8VGVA.0&utm_referrer=https%3A%2F%2Fwww.google.com%2F
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Mesh Surgery for Anterior Vaginal Wall Prolapse: A Meta-analysis.
Aug 2, 2016 | Uro Today
Pelvic organ prolapse (POP) is a major health issue worldwide, affecting 6-8% of women. The most affected site is the anterior vaginal wall. Multiple procedures and surgical techniques have been used, with or without the use of vaginal meshes, due to common treatment failure, reoperations, and complication rates in some studies. Methods Systematic review of the literature and meta-analysis regarding the use of vaginal mesh in anterior vaginal wall prolapse was performed. A total of 115 papers were retrieved after using the medical subject headings (MESH) terms: 'anterior pelvic organ prolapse OR cystocele AND surgery AND (mesh or colporrhaphy)' in the PubMed database. Exclusion criteria were: follow-up shorter than 1 year, use of biological or absorbable meshes, and inclusion of other vaginal wall prolapses. Studies were put in a data chart by two independent editors; results found in at least two studies were grouped for analysis. Results After the review of the titles by two independent editors, 70 studies were discarded, and after abstract assessment, 18 trials were eligible for full text screening. For final screening and meta-analysis, after applying the Jadad score (> 2), 12 studies were included. Objective cure was greater in the mesh surgery group (odds ratio [OR] = 1,28[1.53." class="hasTip1" style="cursor: pointer;">1,07-1,53]), which also had greater blood loss (mean deviation [MD] = 45,98 [9.25." class="hasTip1" style="cursor: pointer;">9,72-82,25]), longer surgery time (MD = 15,08 [0.67." class="hasTip1" style="cursor: pointer;">0,48-29,67]), but less prolapse recurrence (OR = 0,22 [01.38." class="hasTip1" style="cursor: pointer;">01,3-0,38]). Dyspareunia, symptom resolution and reoperation rates were not statistically different between groups. Quality of life (QOL) assessment through the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12), the pelvic floor distress inventory (PFDI-20), the pelvic floor impact questionnaire (PFIQ-7), and the perceived quality of life scale (PQOL) was not significantly different. Conclusions Anterior vaginal prolapse mesh surgery has greater anatomic cure rates and less recurrence, although there were no differences regarding subjective cure, reoperation rates and quality of life. Furthermore, mesh surgery was associated with longer surgical time and greater blood loss. Mesh use should be individualized, considering prior history and risk factors for recurrence.
http://www.urotoday.com/categories/1165-pelvic-organ-prolapse/90434-mesh-surgery-for-anterior-vaginal-wall-prolapse-a-meta-analysis.html
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