Complications from Mesh Used to Reinforce Vaginal Walls
What Vaginal Mesh Products Are Involved?
Transvaginal surgical mesh is permanently implanted to reinforce a weakened vaginal wall during procedures to correct pelvic organ prolapsed (POP) and stress urinary incontinence (SUI). In the United States alone, market data from manufacturers confirms that more than 500,000 women underwent procedures for these conditions in 2010. And, nearly one of three POP surgeries, and approximately three of four SUI surgeries, involved the implant of transvaginal mesh.
What Complications Can Transvaginal Mesh Create?
Over the last several years, the United States Food and Drug Administration (FDA) has received more than 1,000 reports detailing complications associated with transvaginal mesh. These problems include:
- pain
- infection
- injuries to organs, nerves, and blood vessels
- recurrence of prolapse and incontinence
Additionally, between 2008 and 2010, there were three reported deaths-resulting from bowel perforations and hemorrhage-related to mesh placement procedures.
What Are The FDA Warnings Regarding Pelvic Organ Prolapse and Stress Urinary Incontinence?
In October 2008, the FDA issued a " Dear Healthcare Practitioner" letter to alert healthcare providers to "complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)." In this warning, the FDA made the following recommendations:
Physicians should:
- Obtain specialized training for each mesh placement technique, and be aware of its risks.
- Be vigilant for potential adverse events from the mesh, especially erosion and infection.
- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.
Read the entire FDA warning to healthcare providers.
The FDA has also released warnings to consumers about the potential complications that may occur with transvaginal surgical mesh. According to the FDA, such complications can have "serious consequences."
Who Manufactures the Defective Vaginal Mesh Products in Question?
Complications have been linked to products-transvaginal mesh, tape, slings, and other products-manufactured by nine companies. These products include those manufactured by Johnson & Johnson (Ethicon, Gynecare and Gynemesh products) and C.R.Bard (Avaulta, Faslata, Pelvicol, PelviSoft and Pelvitex products).
Contact Proven Ohio Transvaginal Surgical Mesh Attorneys
Clark Perdue has extensive experience handling claims involving defective medical devices. If you have suffered injury or pain as a result of a transvaginal mesh implant, and you would like more information, please contact the Columbus Ohio Transvaginal Mesh Implant attorneys at Clark, Perdue & List.
