Transvaginal Mesh Results in Serious and Permanent Vaginal Mesh Complications, Says FDA Report
In July of 2011, the FDA published a Vaginal Mesh Safety Alert that cautioned against the use of vaginal mesh for pelvic organ prolapse repair surgery. Reports of serious health complications from transvaginal mesh have increased five-fold in the last three years. The FDA warns that transvaginal placement of surgical mesh can cause serious, irreversible and life-changing health problems. Furthermore, the FDA Vaginal Mesh Safety Alert urges urogynecologic surgeons to warn their patients of the risks associated with transvaginal mesh, and ideally, to consider alternative surgeries whenever possible.
Understanding Pelvic Mesh Risks
The public's understanding of the risks posed by pelvic mesh has evolved over the last decade. Because surgical mesh has been used successfully in other muscle repair surgeries for decades, it was generally assumed to be safe for implantation in the pelvic area. However, in 2008, the first FDA Transvaginal Mesh Safety Alert was issued, warning surgeons that vaginal mesh posed rare but serious health risks. Because vaginal mesh complications were believed to be rare, pelvic organ prolapse repair surgery was still considered a routine and low-risk surgery. The new FDA Transvaginal Mesh Safety Warning confirms that transvaginal mesh problems are a real threat to many women.
Most women who have had pelvic mesh implanted were not aware that pelvic mesh is a permanent and potentially dangerous medical device. Sadly, instead of the easy recovery and return to normal activity that they had anticipated, many women now suffer from persistent health problems as a result of the pelvic mesh.
Women who have been harmed by vaginal mesh wonder why vaginal mesh side effects information was not made public sooner. Several factors contributed to this situation, including a controversial medical device approval practice by the FDA and a lack of safety testing for vaginal mesh products.
Vaginal Mesh Complications
Transvaginal mesh problems are caused most commonly by mesh erosion or mesh extrusion. Vaginal mesh erosion occurs when the material starts to decompose, and pieces of it may break off and become lodged in bodily tissues. Vaginal mesh extrusion refers to a condition in which the pelvic mesh works its way out of the area where it hass been implanted and the material's sharp ends aggravate the pelvic area. These circumstances can result in severe pain, profuse bleeding, pelvic organ damage, infection, vaginal shrinkage and scarring, and even emotional problems. The implantation of transvaginal mesh is most accurately considered a permanent and irreversible procedure, as transvaginal mesh can never be completely removed. Some women who suffer from vaginal mesh side effects have been subjected to ten or more surgeries to remove vaginal mesh shards, and yet continue to experience ongoing health problems.
Vaginal Mesh for Pelvic Organ Prolapse Repair
Vaginal mesh is a synthetic mesh product that was developed for use specifically to make surgical repairs to the pelvic area. Vaginal mesh is used in the treatment of two medical problems, pelvic organ prolapse and stress urinary incontinence. The 2011 FDA Vaginal Mesh Safety Alert refers specifically to cases in which vaginal mesh is used for pelvic organ prolapse repair. Pelvic organ prolapse is a condition that a majority of women will experience to some degree during their lifetime, usually as a result of childbirth, hormonal changes during menopause, or pelvic surgeries such as hysterectomy. When the pelvic muscles become weak, torn or otherwise damaged, they can no longer provide adequate support to the pelvic organs (such as the bladder, bowels, and uterus), which then hang or push (prolapse) into the vaginal cavity. Extreme cases of this condition require surgical repair, which can involve simple sutures or rely on a medical product like pelvic mesh. Whether vaginal mesh is used or not, the goal of the surgery is to bolster the pelvic muscles in order to lift the pelvic organs into their proper places and restore ordinary health and mobility.
FDA Says Vaginal Mesh Heightens Risk without Adding Benefit
In addition to stating that the risk of pelvic mesh health complications is higher than the agency previously thought, the FDA Pelvic Mesh Safety Alert also states that the medical device offers no clear benefit over traditional sutures. Pelvic mesh kits are manufactured and sold by nine different medical device companies, including Johnsons and Johnson, a company that has been hit by one medical recall after another of late. Marketing claims about vaginal mesh's convenience and safety are in sharp contrast to the findings of Dr. William Maisel. "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. Pelvic mesh can result in lifelong and significant health problems, and the FDA now asserts that pelvic mesh poses no clear health benefit over sutures.
Public Citizen Urges FDA to Recall Transvaginal Mesh
During August of 2011, on the tails of the FDA Transvaginal Mesh Safety Alert, the consumer watchdog organization Public Citizen pressed the FDA to go even further. Instead of merely warning surgeons against vaginal mesh, Public Citizen demanded that problematic vaginal mesh products be recalled. Citing vaginal mesh recalls in two European companies, the group believed the FDA had fallen short of protecting American consumers. Dr. Michael Carome, deputy director of Public Citizen's Health Research Group asserted that, "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 on dangerous pelvic mesh products now on the market, Public Citizen also advocated for a ban on marketing of pelvic mesh, and a change in FDA product classification. The current classification for transvaginal mesh is a controversial practice at the FDA that allows for new medical products to be approved that are essentially similar to other approved products. If the FDA does in fact change the classification of vaginal mesh, clinical safety testing would be required prior to new product approval.
Mesh Erosion and Extrusion are Common Vaginal Mesh Complications
Women who have already had pelvic mesh implanted may suffer from lifelong side effects as a result. Surgery to remove pieces of mesh may help to relieve some of their suffering, but past cases have shown that pelvic mesh can never be removed in its entirety. Patients who suffer from transvaginal mesh problems such as vaginal mesh erosion or extrusion, will typically require at least two more surgeries in order to remove the problematic mesh and then to repair the initial prolapse with sutures. Some pelvic organ prolapse patients with pelvic mesh problems have been subjected to many hospitalizations and a dozen revision surgeries in order to remove vaginal mesh shards. Vaginal mesh can begin to disintegrate within the first month after implantation. A recent study found that at least ten percent of patients experienced vaginal mesh erosion during their first post-operative year.
More information on Vaginal Mesh can be found at The Onder Law Firm's Vaginal Mesh website at www.pelvicmeshlawyers.com.