I am providing this update and commentary involving TV Mesh failures.
An FDA advisory panel is currently examining recent complications and failure reports associated with transvaginal mesh systems that are used to repair pelvic organ prolapse, POP.
The FDA’s Obstetrics and Gynecological Devices panel will offer recommendations to protect women from the serious debilitating problems associated with transvaginal use of surgical mesh, which medical evidence suggests may provide no actual benefit over more traditional means of treating pelvic organ prolapse.
The transvaginal mesh products, known as bladder sling or vaginal surgical mesh, are designed to support the bladder and vagina in older women. The products are sold by a number of different companies, including Ethicon, C.R. Bard, American Medical Systems (AMS), Boston Scientific among others. They are made of non-absorbable synthetic material that is permanently implanted using small incisions as an alternative to other methods of treating pelvic organ prolapse.
The FDA issued warnings in July to inform the public and medical community about the growing number of reports involving transvaginal mesh failure after use to repair pelvic organ prolapse, including erosion of the mesh into the vagina, pain, bleeding, organ perforation and recurrence of POP.
According to a report the FDA agency is considering the reclassification of all transvaginal mesh products as Class III medical devices, which would prevent companies from seeking market approval through the agency’s “fast track” 510(k) approval program. The program allows medical devices to be approved without rigorous testing if they are functionally equivalent to existing products.
Johnson & Johnson (JNJ) and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.
Manufacturers including J&J and Endo Pharmaceuticals Holdings Inc. (ENDP) proposed that new versions of the devices require clinical trials before they can be sold and existing implants be tracked for safety.
More than 75,000 women received vaginally implanted meshes last year to strengthen weak pelvic muscles that fail to support internal organs. Patients claiming the meshes led to internal injuries have filed almost 500 lawsuits against two of the manufacturers, New Brunswick, New Jersey-based J&J and C.R. Bard Inc. of Murray Hill, New Jersey.
The FDA is evaluating a U.S. Institute of Medicine report in July urging it to scrap the 510(k) process for moderate-risk devices. The current system allows devices like the mesh implant to enter the market if manufacturers show they are “substantially equivalent” to others already for sale. The IOM said a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.
Last month, the consumer advocacy group Public Citizen filed a petition with the FDA calling for a transvaginal mesh recall to be issued to prevent the needless exposure of patients to the risk of the painful and life-altering complications.
As a result of complications and failure following the pelvic organ prolapse repair, a number of women throughout the United States are pursuing a transvaginal mesh lawsuit against the makers of the products, arguing that they failed to properly researc
