Surgical mesh is a medical device made of absorbable or non-absorbable synthetic or absorbable biologic material that is used to repair and/or strengthen damaged or weakened tissue. Surgical mesh is widely used in the repair of hernias, pelvic organ prolapse (POP), and stress urinary incontinence (SUI). As with any medical device, the use of surgical mesh presents risks.
When is Transvaginal Mesh Used?
There are two common conditions that require the implantation of surgical mesh through an incision in the vagina: 1) Pelvic Organ Prolapse (POP); and 2) Stress Urinary Incontinence (SUI). POP occurs when a pelvic organ, such as the bladder or uterus, prolapses or drops from its normal position and pushes against the walls of the vagina. This is common when the muscles that hold the pelvic organs in place are weak or stretched as a result of surgery or childbirth. SUI is also commonly treated with the implantation of surgical mesh to reinforce the vaginal wall. SUI, also sometimes referred to as “effort incontinence”, is the inability to prevent involuntary urination as the result of weak pelvic muscles.
Complications of Transvaginal Mesh
In 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification warning of serious complications associated with transvaginal surgical mesh placement for the repair of POP and SUI. Between 2005 and 2007, the FDA had received over 1,000 reports from nine surgical mesh manufacturers of complications, including:
- Erosion through vaginal epithelium
- Infection
- Pain
- Urinary problems
- Recurrence of incontinence or organ prolapse
The treatment of these complications includes drainage of hematomas or abscesses, blood transfusions, IV therapy, and additional surgeries. Because the complications were considered “rare” at this time, there was no official action taken beyond the public notice, until July of 2011 that is.
July 2011 FDA Safety Alert
On July 13, 2011, the FDA issued an official safety alert warning healthcare professionals and patients that the serious complications associated with transvaginal placement of surgical mesh are “not rare.” From January 1, 2008 through December 31, 2010, there were an additional 2,874 reports of complications resulting from transvaginal implantation of surgical mesh used to repair SUI and POP. In fact, it was determined that “mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.” The FDA plans to conduct more clinical studies as well as move transvaginal surgical mesh to the Class III category of medical devices, which pose the highest risk.
How We Can Help You
The complications associated with using transvaginal mesh for the repair of POP or SUI are completely avoidable. As the FDA determined, other traditional non-mesh methods of repair do not have the same risks. If you have suffered illness or injury as the result of a transvaginal mesh repair of POP or SUI, whether due to negligence on the part of your physician or negligent manufacturing or defective design of the mesh itself, you may have cause for legal action. At Massey & Associates, P.C., our experienced Tennessee transvaginal mesh attorneys can help you hold the at-fault party liable for the damages and losses you’ve suffered as a result of their negligence. Contact us today to learn more about your legal rights and options at (423) 396-0720.
