New FDA Warning Outlines Risks Associated With Vaginal Mesh amd Pelvic Mesh Devices
On July 13, 2011, after receiving over 1500 adverse event reports relating to serious injuries caused by the implantation of polypropylene transvaginal device/mesh, the FDA issued a comprehensive medical alert to physicians warning that, in most instances, the risk of serious injury outweighed all purported benefits associated with the use of these devices. Specifically, the FDA found that traditional procedures, which did not utilize polypropylene devices/mesh, should be the primary course of treatment and that implantation of these devices should limited to procedures of last resort.
Common complications are as follows:
- Erosion of the mesh into the vagina
- Urinary problems
- Pelvic Pain
- Vaginal Pain
- Hardening of the vaginal mesh
- Injury to nearby organs
- Difficulty during sex after vaginal surgery
- Destroyed Marital Relations
Recent Research Indicates Serious Risks and Complications
Victims of defective transvaginal mesh and pelvic/bladder support products are filing suit against the manufacturers nationwide following the shocking results of a clinical study. The study was stopped before completion because the problems they were seeing in patients were too severe to continue the research. More than 15 percent of women in the study experience the dangerous and painful condition known as “erosion,” in which the skin splits and the mesh protrudes.
The transvaginal products (mesh, tape and sling devices) are manufactured by several companies, including Ethicon/Gynecare/Johnson & Johnson and C.R.Bard, Inc., and are marketed as solutions for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Many patients have reported experiencing serious problems, including: pain (during urination/intercourse and/or localized); infection; migration; erosion and corrective surgeries. According to a recent article in the Journal of Obstetrics and Gynecology, patients would have been better off with traditional treatment.
Among the defective devices, the Mentor ObTape and Bard’s synthetic and/or biologic Avaulta mesh have been associated with serious complications. In 2006, after numerous reports of adverse events surfaced, Mentor discontinued sales of its ObTape. More recently, adverse reports regarding the Bard Avaulta product line, marketed as the Avaulta Solo™ Synthetic and Avaulta Anterior and Posterior Biosynthetic Support Systems, have caught the attention of the medical community and the FDA. However, all synthetic and biologic devices sold in the United States are under investigation regarding problems with device degradation, infection and vaginal wall erosion.
Prior Transvaginal Mesh Warnings From the FDA
In 2008, the FDA issued a Safety Alert to doctors and the public. This alert reported that the most frequent complications included:
- Mesh erosion through vaginal wall or other body parts
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bladder, bowel or vessel perforation
- Vaginal scarring
- Pain during sexual intercourse
- Other problems that led to a significant decrease in patient quality of life due
to discomfort and pain.
Four Transvaginal Device Manufacturers Implicated
Johnson & Johnson®
- Ethicon® TVT
- Gynecare® TVT
- Gynecare® Prosima
- Gynecare® Prolift
- Gynemesh® PS
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
- Avaulta Plus™ BioSynthetic Support
- Avaulta Solo™ Synthetic Support
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems®
Transvaginal Mesh Lawsuit
If you or a loved one has been the victim of complications from transvaginal mesh, call 1-866-959-3877 or email our office today.