What Are Transvaginal Mesh Implants (TVM)?
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non–absorbable synthetic material or absorbable biological material. Surgical mesh was originally developed in the 1950’s to repair abdominal hernias. In the 1990’s surgical mesh began to be used for treatment of women’s gynecological and urological problems including repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). In POP procedures the mesh is permanently implanted to reinforce the weakened vaginal wall. In SUI procedures the mesh is used to support the urethra or bladder neck.
Manufacturers are allowed to market mesh products for transvaginal use based on claims that the POP and SUI procedures are “substantially equivalent” to the use of surgical mesh for hernia repairs. Based on these representations, the FDA allowed manufacturers to market surgical mesh products for gynecologic and urological procedures without conducting clinical testing to establish the safety and efficacy of mesh products for POP and SUI procedures.
Complications from the Transvaginal Mesh Implants
Patients have reported numerous problems from the use of transvaginal mesh (TVM) implants. Among the most serious complications are mesh erosion, extrusion of the mesh, perforation of surrounding organs, infection, painful sexual intercourse and vaginal bleeding and chronic pain. Other problems associated with TVM include urge incontinence or difficulty urinating.
One of the most painful complications of TVM implants is erosion. If the mesh erodes, pieces of the mesh can pierce the vaginal wall and become exposed. The mesh can also erode into the bladder causing bleeding, urinary tract infections, and severe pain in the lower abdomen.
When complications do arise, many women require multiple procedures in an attempt to remove the problem-causing mesh. However, when complications do require surgical revisions, it is often difficult to remove the mesh once it has been imbedded in the patient.
In October 2008 the FDA issued an alert notifying doctors and the public of more than 1,000 reports of adverse events associated with the use of TVM to repair POP and SUI. In July 2011 the FDA updated its warning regarding the use of TVM in POP procedures. In its July 2011 alert the FDA noted that complications from the use of TVM in POP procedures were not rare, and that it had not been established that the use of TVM in POP procedures was safer or more effective than traditional methods of treating POP. On January 4, 2012, the FDA issued an update indicating that it was considering reclassifying transvaginal repair of POP as a Class III medical device which is in the highest risk category.
To date, the FDA has not issued any recall of a TVM device. However, some of the manufacturers of TVM devices have pulled their products from the market. In 1999 Boston Scientific stopped marketing its ProteGen sling. In 2006 Mentor stopped marketing its OB tape products. In June of 2012, Ethicon stopped selling its Gynecare TVM product line including TVT Secur, Prosima and Prolift products.
If you are having problems due to a transvaginal mesh implant, contact me, Richard Langerman, to arrange for a free consultation and case evaluation. You will pay no attorney’s fees unless I recover financial compensation in your product liability case.