Home » Law and Legal Articles » Transvaginal Mesh Risks Again Raise Concerns About 501(k) Approvals
Transvaginal Mesh Risks Again Raise Concerns About 501(k) Approvals
Concerns about the dangers of transvaginal mesh continue as more lawsuits are filed against manufacturers.
January 07, 2012 /Law and Legal PR News/ -- One of the processes that the Food and Drug Administration (FDA) utilizes to clear medical devices for use continues to raise safety concerns. The concerns about the FDA's 501(k) process come as more medical-product liability lawsuits are being filed against Johnson & Johnson and other manufacturers of transvaginal surgical mesh.
Transvaginal Surgical Mesh
Transvaginal mesh is used to treat medical conditions in women such as pelvic organ prolapse and urinary incontinence. To ameliorate these conditions, transvaginal mesh is permanently implanted to strengthen the pelvic tissues or provide stability to the urethra.
Pelvic organ prolapse is a condition in which the pelvic organs bulge into the vaginal area due to a weakening or stretching of the muscles or ligaments that hold the organs in place. The condition frequently occurs in women who have given birth, but not exclusively.
In July 2011, the FDA issued an alert stating that it had received nearly 3,000 reports of complications following the use of transvaginal mesh to treat pelvic organ prolapse from 2008 to 2010. The FDA alert stated that it is "not rare" for "serious complications" to arise when transvaginal mesh is used to treat pelvic organ prolapse.
Further, the FDA stated that "it is not clear" that using transvaginal mesh to treat pelvic organ prolapse "is more effective than traditional non-mesh repair in all patients." And, using transvaginal mesh actually "may expose patients to greater risk."
The FDA lists the most common complications of transvaginal mesh implantation as:
- Mesh erosion (also known as extrusion, protrusion or exposure)
- Infection
- Pain
- Pain during intercourse (dyspareunia)
- Bleeding
- Urinary problems
- Organ perforation
With the release of the FDA's alert, not only are concerns being raised about the transvaginal mesh products themselves, but concerns are also being raised about the FDA process that was used by manufacturers to have the mesh products cleared for use.
FDA 501(k) Clearance Process
Under the FDA's 501(k) clearance process, newly developed or manufactured medical devices can be cleared for use with little testing if the new device is substantially equivalent to a medical device already cleared for use -- known as a predicate device -- by the FDA. According to an article by Bloomberg, each year the FDA uses the 501(k) system to review approximately 90 percent of all new medical device clearance applications.
While the 501(k) system allows medical-device manufacturers to avoid the time and expense of comprehensive testing and get medical devices to patients faster, Bloomberg reported that safety advocate Amy Allina, a policy director at the National Women's Health Network, believes the system has a "key flaw."
The system is designed to allow each new device to rely on a similar device already cleared by the FDA as its predicate. However, if the original predicate device is ever voluntarily pulled from the market or is shown to pose safety risks, the later, similar devices given fast-track approval through the 501(k) system are still able to be used. This is exactly what happened with the vaginal mesh products that are now the subject of many personal injury lawsuits.
Vaginal Mesh Approval
In 1996, vaginal mesh developed by Boston Scientific, ProteGen mesh, was cleared for patient use by the FDA. Subsequently, ProteGen was listed as a predicate device by Johnson & Johnson in the 501(k) approval process for its Gynecare TVT product.
However, within a year of being cleared, ProteGen was pulled from use after the FDA received over 120 reports that it was causing issues such as discomfort, vaginal tissue erosion and painful intercourse. Yet, as Bloomberg points out, Johnson & Johnson's Gynecare TVT product remained available for use and was used as a predicate in other manufacturers' vaginal mesh 501(k) applications and approvals, even though the original predicate device had been shown to pose injury risks to patients.
Speaking about the FDA's 501(k) clearance of transvaginal mesh, pelvic surgeon Thomas Margolis was quoted by Bloomberg as saying, "The FDA got caught with their pants down. The ProteGen should have told them, 'Wait a minute, all of these mesh systems are bad.'"
Transvaginal mesh is not the first product that has called into question the 501(k) approval process, either.
Other 501(k) Issues
The FDA's 501(k) process was also used to clear both Johnson & Johnson's DePuy hip implants and Medronic's Sprint Fidelis defibrillators, which turned out to be dangerous to patients. Both medical devices, like transvaginal mesh, have been the focus of many personal injury lawsuits. It has been speculated that the Sprint Fidelis may have contributed to over 100 fatalities, and both the hip implants the defibrillators have been recalled.
Speak with an experienced medical-device products liability attorney if you or a loved one has had transvaginal mesh implanted and subsequently experienced complications.
Article provided by Greene, Ketchum, Bailey, Walker, Farrell & Tweel
Visit us at www.greeneketchum.com
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