Transvaginal Surgical Mesh

Implantable Devices and Defective Surgical Tools — Hersh & Hersh Transvaginal Surgical Mesh Attorneys

The transvaginal surgical mesh used to repair such conditions as pelvic organ prolapse (POP) and Urinary Stress Incontinence in women is a growing area of concern and injury for those patients having undergone corrective procedures. Hersh & Hersh has represented patients who have suffered harm from many implantable devices and defective surgical tools and has represented women dealing with injuries from the use of transvaginal surgical mesh.

Hersh & Hersh has been at the forefront of this litigation and has a great deal of expertise in handling these cases. In addition, we have a long history of landmark litigation involving women’s health, including defective devices and dangerous drugs that have particularly impacted women.

The use of transvaginal surgical mesh to repair POP or stress urinary incontinence is now known to be very controversial and likely not warranted medically. Other surgical methods are available to make these repairs without the complications of surgical mesh. The complications associated with this device are now well-documented and include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. Other complications include bowel, bladder, and blood vessel perforation in the surgical procedure. Other problems have included vaginal scarring and mesh erosion which result in pain, discomfort and reduced quality of life.

The FDA recently issued an alert to health care and medical professionals to warn them of complications associated with the placement of surgical mesh in women with Pelvic Organ Prolapse and Stress Urinary Incontinence. This is an unusual action on the part of the FDA. The action was taken because so many women have been injured by the use of vaginal mesh and there are other surgical procedures to correct these problems that do not include the use of mesh.

In September 2011, the FDA held hearings on the use of transvaginal surgical mesh for the repair of POP and stress incontinence. The hearings resulted in many recommendations that will impact the use of this device in women for POP and urinary incontinence.

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA held the hearings which were open to the public. One important result of these hearings is the FDA’s recommendation that vaginal mesh should be reclassified from Class II (Special Controls) to Class III (Premarket Approval) which would result in designed clinical trials.

The Advisory Panel reached consensus that:

• vaginal mesh safety in POP repair has not been well-established,
• it may not be more effective than traditional repair methods,
• the risk-benefits of mesh are not well-established,
• and, studies are needed to evaluate the use of surgical mesh for POP repair.

The panel also reached consensus that transvaginal surgical mesh should be reclassified to Class III. Patient information such as labeling and informed consent and mandatory registration of mesh devices used in procedures, surgical training, education, and credentialing are all important components.

Passionate Representation, Historic Results in Surgical Device Litigation

If you or a loved one have been injured or suffered complications after the insertion of transvaginal surgical mesh, please contact us at our San Francisco, California law offices or call us at 1-800-441-5545 for a free consultation with one of our attorneys.