FDA Reviews of Vaginal Mesh
As many women injured by vaginal mesh unfortunately already know, these devices can lead to dramatic and heartbreaking consequences, severe physical pain, real emotional distress, and be a catalyst in the destruction of intimate relationships. In this blog we review a little of the history and actions by the FDA.
WHAT IS VAGINAL MESH?
Vaginal mesh is a synthetic, knitted, woven mesh usually made from polypropylene that is placed in a woman’s vagina to reinforce the internal structures that support the pelvic organs. When the muscles become so weak or stretched that the organs drop from their normal position into or out of the vagina (prolapse), surgical repair may be necessary. Mesh is used in an effort to strengthen the support and to encourage the growth of the woman’s own tissue in the vagina to reinforce and strengthen the weakened tissue and to provide organ support. Vaginal mesh is typically used in a case where an organ such as the bladder, uterus, small intestine, the roof of the vagina, or the urethra bulges into or out of the vagina. This occurs due to weakness or stretching in the muscles that support the pelvic floor such as after childbirth
The FDA first cleared vaginal mesh in the late 1990’s based on its similarity to earlier products used to fix internal hernias. Despite using a different method of implantation (inserted through the vaginal wall, rather than with abdominal surgery) and for an entirely different part of the body, surgical mesh “kits” were advertised as a new and improved method to treat urinary incontinence. By using the historical role of mesh the manufacturers were able to pursue mesh as a Class II device allowed to be marketed under the 510 (k) process based on the manufacturers claim it is “substantially equivalent” to a product already on the market bypassing safety and efficacy assurances and not requiring the stricter process of a Class III device.
In 2008, the FDA said that surgical mesh complications were serious, but rare. In the case of vaginal mesh, the most common problem was mesh eroding and sticking through the walls of the bladder or vagina, causing burning and pain. A 2011 study published in the Journal of Obstetrics and Gynecology Canada stated, “Until adequate effectiveness and safety evidence is available, the use of the new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials. Vaginal mesh products are primarily made by Johnson & Johnson, Bard, Boston Scientific and American Medical Systems under a variety of brand names
On July 13, 2011, the FDA issued a safety communication warning women that the continued use of transvaginal mesh was an area of “continuing serious concern” and reporting that serious complications from the use of this mesh are not rare. The safety concerns relate to all brands and all manufacturers of this product and represent a major shift in policy from the FDA’s October 2008, notification that complications were rare. Over a three-year span, manufacturers have reported adverse events in over 1000 surgeries to the FDA. The FDA believes that this number is grossly understated.
On August 31, 2011, a FDA staff report stated, “Because of the outstanding safety and effectiveness concerns for mesh products indicated for vaginal POP repair and an inability to adequately address these concerns via the 510(k) pathway, the FDA believes that 510(k) premarket notification is no longer an appropriate premarket pathway for devices indicated for vaginal POP repair. Therefore the FDA believes that reclassification of these devices to Class III and evaluation via the PMA process is warranted.” The report says the rate and severity of mesh-specific adverse events such as pain, immobility, infection, mesh erosion, a return of incontinence and prolapse following vaginal POP repair “calls into question the safety of these devices.”
Under the proposal, synthetic surgical mesh would be reclassified as a high risk or Class III device to repair pelvic organ prolapse. The significance of the reclassification is that Class III designation would require manufacturers to independently demonstrate the safety and effectiveness of mesh by submitting it for premarket approval including clinical trials, scientific studies, and post-approval studies to obtain long-term data. Annual reporting and label changes could be required.
Presently, surgical plastic mesh is a Class II device (moderate risk) and is allowed to be marketed under the 510 (k) process as manufacturers claim it is “substantially equivalent” to a product already on the market bypassing safety and efficacy assurances. This allows manufacturers to present a new product as substantially equivalent to a previously approved product and then market it as “the next generation” or a“ revolutionary breakthrough” without appropriate testing to reveal the true risks, benefits, and side effects. Once a device is approved and on the market it is known as a predicate and serves as the predicate for a third or fourth device. The 510(k) process was used to approve successively the vaginal mesh products. Too many dangerous products that were later recalled were approved under the 510 (k) process (See DePuy ASR).
The agency continued its review of SUI (stress urinary incontinence) complications and reported from January 1, 2008 through September 30, 2011, the FDA received “1,876 reports of complications associated with surgical mesh devices used to repair SUI.”
That represents more than a 36% increase in adverse event reports to the FDA in nine months.
On January 3, 2012, the FDA ordered post market surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices to address specific safety and effectiveness concerns related to mini-sling devices for SUI (stress urinary incontinence) and surgical mesh used for transvaginal repair of POP (pelvic organ prolapse). This order was based on the FDA’s evaluation of the published literature, analysis of adverse events reported to the FDA and feedback from the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee.
As of February 27, 2012, the FDA issued:
- 95 postmarket study orders to 34 manufacturers of urogynecologic surgical mesh for POP; and
- 14 postmarket study orders to seven manufacturers of mini-slings for SUI
Click here to read the full FDA article: FDA’s Role and Activities
The NY Times reported from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse, according to Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices.
Click here to read the full New York Times article: FDA Orders Surgical Mesh Makers to Study Risks
On its website on March 27, 2013, the FDA stated:
The FDA conducted a review of Medical Device Reports (MDRs) received from January 1, 2008 through September 30, 2011. During this time frame the FDA received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.
The most common complications reported through MDRs for surgical mesh slings for SUI repair, in descending order of frequency, include pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.
There are over 10,000 women who have filed suits detailing their injuries from the mesh inserted in them. We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings. If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.