FDA Warning for Surgical Mesh in Transvaginal Placement to Repair Pelvic Organ Prolapse
FDA Issues Second Transvaginal Mesh Safety Warning
The FDA has issued two separate warnings about the dangers of surgical mesh for pelvic organ prolapse repair. The first took place in 2008 and was referred to as a “Public Health Notification”. This document stated that serious surgical mesh side effects had been found to occur in rare cases after pelvic organ prolapse repair. Then, in July of 2011, the FDA issued a second warning, this one entitled a “Safety Communication”, which amended the first warning. It states that serious side effects from vaginal mesh are not rare after all. The document lists a number of important statements to support its ultimate conclusion that alternate repair methods should be utilized whenever possible. In plain, transvaginal mesh is not a safe or responsible method of pelvic organ prolapse repair. Women who have already have vaginal mesh implanted for POP repair and are now experiencing pelvic organ prolapse have grounds for a mesh lawsuit.
FDA 2011 UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Significantly, the FDA alert states that it is not clear that transvaginal mesh offers any benefits over other forms of surgery to repair pelvic organ prolapse. It is clear that it poses higher and more serious risks; in fact the document states that, “Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.” Using surgical mesh to repair pelvic organ prolapse represents a medical risk with no clear benefit for the patient. This raises the question of why this product would ever be used at all.
The document also reveals that serious side effects and health problems are not uncommon following the transvaginal placement of surgical mesh in pelvic organ prolapse repair, as formerly believed. Perhaps most importantly, the FDA warning presents data which show that more patients are experiencing negative side effects from transvaginal mesh. Five times as many people reported problems with surgical mesh after POP surgery between 2008 and 2010 than had between 2005 and 2007.
The alert also gives detailed information about the types of side effects that have come to be associated with POP repair surgery and surgical mesh. These side effects can be life-altering and permanent for some women. The most common side effect experienced by women after having transvaginal mesh implanted for POP is mesh erosion or extrusion. Basically, this means that the mesh begins to break down in the weeks, months and years following pelvic organ prolapse repair surgery. Not only will it then fail to support the pelvic floor muscles, it can also stick out into the vagina. This circumstance commonly leads to immobilizing pain, infection, bleeding, pain during intercourse and urinary problems. Less common problems that were reported to the FDA from vaginal mesh are recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Another problem associated with transvaginal mesh – one that was not formerly reported upon – is mesh contraction. In this circumstance, the surgical mesh shrinks and causes vaginal shrinkage, shortening and pelvic pain.
The report also states that many women who have POP repair surgery with transvaginal mesh require later surgeries. Of patients who experience vaginal mesh erosion, approximately half require at least one more surgery to excise the problematic material. In some cases, women have had to undergo several surgeries to remove the surgical mesh and even then may still face lifelong side effects.
Transvaginal surgical mesh was first approved by the FDA for POP repair surgery during 2002, and now there are many similar products on the market. Labeled a Class II medical device, transvaginal mesh can be approved without human testing if it is similar to other products that have already met FDA approval. At this time, nine different companies produce a similar product, which is designed specifically for POP repair. The FDA report clearly states that no specific brand of vaginal mesh has been found to cause fewer or greater side effects than any other. While falling short of recalling the product, the safety alert makes strong recommendations to clinicians and surgeons to avoid the use of transvaginal mesh. When it is to be used, surgeons are urged to warn patients of the likely risks.
For patients who have already had a POP repair surgery that made use of surgical mesh, there is no need for alarm unless you are experiencing health problems. If you are having health problems such as pelvic pain, vaginal bleeding or spotting, supposed infection, pain during intercourse, or urinary problems, you may learn about your legal rights by filling out our form and speaking with an experienced pelvic mesh lawyer.