Vaginal Mesh Problems are Subject of FDA Alert
During July of 2011, the FDA issued a safety communication declaring transvaginal applications of surgical mesh to be unsafe due to the product's tendency to cause permanent and life-altering pelvic mesh problems in some women. This is not the first time the FDA has warned surgeons and patients about the risks associated with vaginal mesh; this recent warning was an update on a 2008 transvaginal mesh problems safety alert. The 2011 document states that serious vaginal mesh problems are far more likely than the agency had previously believed. The most frequent mesh problem documented by the FDA’s MedWatch program is mesh erosion or extrusion, a circumstance that can lead to infection at the mesh site; bleeding; pain during sexual intercourse; organ perforation caused by surgical tools; and urinary problems. MedWatch received five times the number of reports of transvaginal mesh problems in the last three years (2008-2010) than it had during the three years previous to that (2005-2007).
Transvaginal Mesh Problems Result from Pelvic Organ Prolapse Repair Surgery
Surgical mesh has been used in transvaginal applications to treat two conditions: pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both of these surgeries have been found to lead to serious pelvic mesh problems, but the 2011 FDA warning addresses vaginal mesh problems that result from POP repair surgery only. Medical professionals expect further communication on mesh problems caused by SUI surgery at a later date. Whereas POP repair surgery utilizes a piece of mesh cut to fit a specific tear or weakness, SUI repair surgery often makes use of a pelvic sling. However, the surgeries are similar in that they are both intended to repair a section of pelvic floor muscles that has been damaged in some way. Most vaginal mesh problems have been traced to synthetic mesh products, though there are also biologic types of surgical mesh that are absorbable by the body.
In order to understand pelvic mesh problems, you’ll need to understand what pelvic organ prolapse is. Common among women who have borne children, POP refers to a circumstance in which the pelvic organs, unsupported by weak or damaged pelvic floor muscles, sag into the vaginal cavity and can even push out the vagina. Women who experience severe pelvic organ prolapse describe a feeling of pressure on their vagina, pelvic pain, and even a sensation that something is falling out of their vagina. The organs that are affected may include the rectum, uterus, bladder, bowels and even the upper part of the vagina. Some cases of POP may be solved with medicine, physical therapy or pelvic floor strengthening exercises. Most serious cases of POP require surgery. Symptoms of POP that may require surgery is pain during intercourse or inability to have vaginal intercourse, and difficulty with urinary and defecatory bodily functions.
POP repair surgery does not necessarily require the use of transvaginal mesh; it may also take the form of simple stitches. In either case, the goal of the surgery is to repair and give strength to the pelvic floor muscles in order to adequately lift the pelvic organs out of the vagina. Transvaginal mesh problems result from the erosion of the mesh that is implanted through the vagina.
Vaginal Mesh Problems and Side Effects
Most vaginal mesh problems result from the mesh eroding or extruding out of the vaginal walls. One study showed that in only months after implantation, 10% of the vaginal mesh disintegrates. Not surprisingly, when the mesh sticks out of the vaginal wall or actually breaks off and becomes embedded in another part of the body, pelvic mesh problems result including inflammation and infection, pain (all the time or particularly during intercourse), and bleeding. When patients experience vaginal mesh problems, they are almost always required to undergo one or more surgeries to remove mesh debris. Significantly, the FDA’s 2011 vaginal mesh safety alert states that the use of mesh has no obvious advantages over stitches. That fact, paired with the well-documented prevalence of serious vaginal mesh problems, leads the agency to recommend surgeons choose alternative POP repair treatments. “There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel of the FDA, in the recent safety alert. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.” Transvaginal mesh problems are severe and in some cases, untreatable and permanent.
The FDA alert cites the following mesh problems resulting from the use of vaginal mesh to treat pelvic organ prolapse:
Vaginal Mesh Problems Spur Public Citizen to Demand Medical Device Recall
Following the FDA’s warning on vaginal mesh problems that result from POP repair, the consumer watchdog group Public Citizen pressed for a medical device recall. The group, headed by Ralph Nader, concluded that based on the evidence presented about the serious nature of transvaginal mesh problems, the FDA should not stop short of removing the controversial product from the market. In a press release, the deputy director of the organization’s Health Research Group, Dr. Michael Carome, stated, “Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life. Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.” In addition to calling for a recall of vaginal mesh, Public Citizen demanded a ban on advertising of products that cause mesh problems and a reclassification of the product by the FDA in order to ensure pre-market testing. Earlier testing on this product could have kept millions of women from being exposed to the risk of developing pelvic mesh problems.
Pelvic Mesh Problems: Risks Are Clear but Benefits Uncertain
The FDA safety alert boldly asserts that while surgical mesh for POP repair has been found to cause significant vaginal mesh problems in many women, the product does not offer any clear advantages over more traditional methods. Historically, POP repair consisted of ordinary stitches. Stitches have not been found to cause the same serious pelvic mesh problems, many of which can become lifelong ailments and can impact a patient’s ability to have sexual intercourse as well as to urinate and defecate normally. Permanent pelvic pain can also result from the use of transvaginal mesh.
Number of Pelvic Prolapse Patients with Vaginal Mesh Problems Rises
The safety alert issued in 2011 was issued to amend an earlier warning on pelvic mesh problems, given in 2008. That first report resulted from an increase in reports of vaginal mesh problems to the MedWatch adverse events reporting program. Surgical mesh has been used to repair pelvic organ prolapse for several decades, but it was not until the early 2000 that a product was developed specifically for transvaginal mesh and marketed for use in POP repair surgeries. Those are the products that are under fire now for causing serious and permanent vaginal mesh problems. The second safety alert was issued in 2011 because the number of reports of pelvic mesh problems after POP surgery had risen again. From 2005 to 2007, over 400 reports of transvaginal mesh problems were made to the FDA; that number increased to over 1500 reports in the period between 2008 and 2010. Close to 1400 reports were filed in the same period connecting vaginal mesh problems with stress urinary incontinence surgery (SUI). The FDA is researching the use of vaginal mesh for SUI repair surgery and another safety communication is expected on the near future, outlining the risk of pelvic mesh problems.
Noting a rise in incidents of transvaginal mesh problems for both POP and SUI repair, the FDA has recommended that surgeons adhere to the following points:
- Consider using alternative surgical methods to repair pelvic organ prolapse.
- Inform patients that mesh implantation is permanent.
- Inform patients that mesh erosion can necessitate further surgery and may cause unresolvable mesh problems.
- Inform patients that serious complications are possible.
- Report any adverse effects or mesh problems be reported via MedWatch.
Vaginal Mesh Problems Require Surgery to Correct; Some Mesh Problems Are Irreversible
Unlike other medical devices that can easily be removed if they are troublesome, surgical mesh is considered a permanent implantation. This is because surgical mesh has a tendency to disintegrate or break off. Some women have had over ten surgeries in which surgeons have removed vaginal mesh debris – and still, bits of mesh remain, as do their vaginal mesh problems like debilitating pain, bleeding and renewed prolapse. Patients with transvaginal mesh problems require a minimum of two surgeries: the first is to remove the bothersome pieces of mesh, and the second is to repair the pelvic organ prolapse through a different means that will not cause pelvic mesh problems. However, two surgeries is a best-case scenario, and many women will never see the end of their vaginal mesh problems, like vaginal extrusions, pain during intercourse, urinary tract erosion, infection and nerve pain.
The FDA report also includes recommendations for patients. If you have already had POP repair surgery and think it may have utilized vaginal mesh, here is what you should do:
- continue to attend routine check-ups
- if you are not sure if your POP repair surgery utilized mesh, ask your surgeon
- contact your doctor in the case of persistent bleeding, pain or other potential mesh problems
- let new doctors know if you have had mesh implanted previously
- report mesh problems to the FDA’s MedWatch program
Mesh Problems Legal Help
If you or a loved one believes you may have suffered from mesh problems as a result of pelvic organ prolapse repair surgery, please contact our lawyers handling transvaginal mesh problems cases. You have legal options and rights and we're here to help.
Onder, Shelton, O'Leary & Peterson, LLC is a law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States, and other firms throughout the nation often seek its experience and expertise on complex litigation. The Onder Law Firm is a recognized leader in window blind cord strangulation and vigorously litigates those and other medical safety cases in an effort to force manufacturers of dangerous products to improve their safety standards. The Onder Law Firm represents cases such as vaginal mesh problems on a contingency basis.