What are Vaginal Mesh Implants?
Transvaginal mesh, also known as pelvic mesh or bladder sling, is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI)
Between 2005 and 2010, nearly 4,000 injuries were reported to the U.S. Food and Drug Administration (FDA) in connection with transvaginal/pelvic mesh devices. But as of 2015, more than 70,000 patients have filed lawsuits as a result of their alleged injuries in the U.S.A alone.
In 2011, the FDA issued a safety alert stating that serious complications associated with surgical mesh for the repair of POP are not rare. The FDA reported that ‘it is not clear’ that the use of surgical pelvic mesh to repair POP is more effective than traditional procedures that do not use surgical pelvic mesh. In September 2011, an FDA advisory panel recommended that mesh for POP be reclassified from ‘moderate risk’ to a ‘high-risk’ medical device.
Who Has Suffered?
Tens of thousands of women globally have suffered physical injuries and emotional and financial distress as a result of the poorly designed and poorly tested transvaginal mesh products.
Lawsuits across the world accuse mesh manufacturers of several counts, including:
- Actively and intentionally misleading the FDA, the medical community, patients and public at large with respect to the safety and effectiveness of transvaginal mesh products.
- Failing to establish safe and effective methods for removal of transvaginal mesh.
- Failure to conduct proper testing and research to determine the risks of surgical mesh for use to treat female pelvic floor disorders.
- Failure to adequately warn of potential complications and injury.
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Complications and side-effects of Transvaginal Mesh products
Mesh can begin to erode through the vaginal walls and surrounding organs within months or even weeks of surgery. The injuries incurred following this type of surgical procedure can impact upon even the most basic of daily activities including sitting and walking.
The physical and emotional harm can impact upon work, relationships and daily activities. Side effects of this procedure can include:
- Extreme pain
- Mesh erosion and erosion of vaginal tissue
- Lower back pain
- Dyspareunia (painful sexual intercourse)
- Abdominal and Pelvic pain
- Recurrence of Urinary Incontinence
- The need for multiple surgeries.
- Chronic vaginal drainage
- Vaginal bleeding, infections and scarring
- Perforations of the bowel, bladder or blood vessels
- Pressure of feeling of ‘fullness’ in the lower abdomen
Lawsuits taken against Mesh Manufacturers
Many women who have received mesh implants have subsequently had to undergo multiple revisionary surgeries to attempt to simply manage symptoms.
In the state of West Virginia (U.S.A) alone there are more than 49,000 federal lawsuits against seven mesh manufacturers.
The device manufacturers in these cases are mostly American Medical Systems and Ethicon, while other manufacturers with pending cases include Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic.
Recalled Mesh Product Descriptions and Side Effects
1 GYNECARE PROLIFT (ETHICON)
- GYNECARE PROLIFT (ETHICON)– a wholly owned subsidiary of Johnson and Johnson, manufactures numerous mesh products, known as pelvic mesh, vaginal mesh and bladder slings, designed to treat pelvic prolapse and/or stress urinary incontinence
Reported side effects:
- Mesh erosion into the vagina, bladder, intestines, uterus
- Mesh shrinkage or contraction
- Mesh migration
- Mesh exposure
- Scar tissue formation
- Pelvic pain
- Urinary incontinence and development of urinary retention,
- Dysuria (painful urination)
- Dyspareunia (painful sexual intercourse)
- Neuropathic pain
- Fistulas and recurrence of prolapsed organs
2) COLOPLAST CORPORATION
- 2) COLOPLAST CORPORATIONWith similar side effects to those listed above Coloplast Corporation manufactures the following products:
- Novasilk Synthetic Flat Mesh
- Restorelle Smartmesh
- Exair Mesh
- Aris Transobturator (TOT) sling
- Minitape Sling
- Omnisure Sling
- Supris Suprapubic Sling
- T-sling with Centrasorb
3) BARD AVAULTA
- 3) BARD AVAULTA Bard Avaluta is a New Jersey based medical device company that design and create the following sling products:
4) AMS APOGEE & PERIGEE VAGINAL MESH
- 4) AMS APOGEE & PERIGEE VAGINAL MESHProducts include:
- MiniArc Precise
5) BOSTON SCIENTIFIC
- 5) BOSTON SCIENTIFICProducts include:
- Advantage Fit
U.K warns surgeons about Transvaginal Mesh use
Proposed guidance and recommendations are being developed by the NHS and other regulatory agencies based on analyses of data regarding adverse event reports linked to transvaginal mesh. The U.K regulatory agencies have proposed several recommendations including:
- A single registry of vaginal implants. Data collected by existing registries will be included in the proposed database.
- Professional guidance for surgical mesh procedures. Guidance will be offered to surgeons regarding mesh products proper use for specific conditions.
- Guidance and programmes to train surgeons on the proper use of vaginal mesh.
- Strict informed consent will be required by all patients prior to undergoing surgery using a vaginal mesh.
- Professional support will be provided to women facing surgeries for recurrent POP or SUI and women facing revisionary surgeries as a result of mesh complications.
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