As far back as the 1950’s abdominal hernia repairs with mesh were performed, and in the 1970’s American gynecologists saw the potential for using mesh in pelvic organ prolapse surgeries. Once a medical device is approved by the FDA, it can be used in any way surgeons see fit, therefore surgeons decided to simply cut the surgical mesh into different shapes, using it to treat pelvic organ prolapse. Pelvic

organ prolapse can occur in women whose pelvic or vaginal walls have become overly stretched following childbirth, menopause or a hysterectomy. When these ligaments are stretched past their limits, the uterus would press on the bladder, causing embarrassing and inconvenient incontinence issues.

Mesh was widely used in these types of surgeries for over four decades, then in the 1990’s surgeons began using hernia surgery mesh in treating stress urinary incontinence as well as the transvaginal repair of pelvic organ prolapse. The FDA eventually approved the first mesh product specifically designed for SUI surgeries in 1996, clearing a similar mesh product in 2002 which was designed for use in pelvic organ prolapse.

These approvals were issued pursuant to the “risk-based, tiered approach,” which means FDA approval is not contingent upon clinical data requirements, rather on the determination that the device or product is substantially the same as an already legally marketed device of the same type. Surgical mesh has continued to evolve in its uses as well as the types used. There are currently several categories of the device including a non-absorbable synthetic mesh, an absorbable synthetic mesh, a biologic mesh derived from bovine or porcine sources and a composite mesh which is a combination of any of the other three categories.

Although there has been less written about the success rate and potential problems when hernia repair with mesh is implemented, the mesh’s function is to produce scar tissue which is then a barrier to the herniation. Unfortunately, there is no way to control the amount of scar tissue, and over time the scar can contract, producing tension and causing pain which can be quite severe. Hernia mesh infections were relatively common in these surgeries and some of the mesh inserts were found to “ball up” after the incision had been closed, leading to complications, and prompting a hernia mesh recall for certain types in 2010. When used transvaginally, the mesh appears to cause a variety of potentially harmful side effects in a fair number of cases. In fact, on July 13, 2011, the FDA issued a press release cautioning surgeons that using surgical mesh in transvaginal placements could carry significantly more risks than other viable surgical options.

The FDA has received a large number of complaints from women who underwent either POP or SUI surgeries which incorporated transvaginal mesh implants as part of the procedure. The mesh can erode through the vaginal tissue causing infections, bleeding, urinary problems, chronic pain, or pain during intercourse. Additionally, other organs can be inadvertently perforated from surgical tools which are required to place the transvaginal mesh. These problems which result from the mesh implant can cause a significant lessening of the enjoyment of life as well as other physical and emotional complications. In 2010 alone, over 100,000 pelvic organ prolapse surgeries took place which involved using transvaginal mesh.

Despite the reported complications of the transvaginal mesh implant, and the FDA warnings, a recall has not yet been deemed necessary. There are several companies which manufacture the mesh implants currently in use, and if you have had a surgery which required a mesh implant, be sure to check with your doctor to find out whether you received one of the implants associated with complications. The failure of the implant can, unfortunately, lead to the necessity of one or more operations to remove the mesh and repair the damage. If you feel you may have suffered harm due to one of these faulty mesh implants, our legal staff is very knowledgeable about the issue and would be glad to discuss your potential case with you and determine whether you have a right to recover damages from use of the implant. Sullo & Sullo, LLP has highly experienced attorneys ready to evaluate your specific case.