Transvaginal Mesh

Transvaginal mesh is a metal or polymeric screen device meant to be implanted surgically to reinforce the walls of the vagina when they are weakened by pelvic organ prolapse (POP). After the stress of childbirth, the organs in the pelvis often prolapse or sag into the walls of the vagina, causing pain, discomfort and other complications.

Types of Injuries Related to Transvaginal Mesh

In recent years, women and their doctors frequently have been reporting many difficulties related to the transvaginal implants. Complications reported to the FDA include:

• Vaginal mesh erosion
• Pain on a daily basis as well as during sexual intercourse
• Infection
• Urinary problems
• Bleeding
• Perforation of organs
• Recurrent prolapse
• Vaginal scarring
• Vaginal shrinkage
• Emotional problems

From 2008 to 2010, seven deaths were reported that were linked to POP repairs. Investigations into these deaths revealed that three were related to the procedure for placing the mesh: two bowel perforations and one hemorrhage. Four of the deaths were caused by medical complications after surgery.

FDA Warnings Regarding Vaginal Mesh

The FDA in October 2008 distributed a Public Health Notification to let doctors and patients know of the problems of using surgical mesh to treat POP.

After issuing its report, the FDA continued to monitor problems. Between Jan. 1, 2008, and Dec. 31, 2010, there were 2,874 Medical Device Reports about adverse events associated with urogynecologic surgical meshes. Of these 1,503 reports had to do with POP repairs.

The FDA found that there was a five-fold increase in the number of adverse events reported from January 2008 to December 2010 compared to the previous three years.

The agency also reviewed the medical literature for articles about the safety and effectiveness of POP and SUI. And, in July 2011, the FDA issued another report, an update to the Public Health Notification. The report included information on the safety and effectiveness of transvaginal placement of surgical mesh to treat POP.

The FDA review of the literature raised numerous safety and efficacy concerns regarding transvaginally placed surgical mesh for POP repair, including:

• Adverse events from this surgery could be a life-altering experience, even if the mesh were removed.
• Mesh-associated complications are not rare, as indicated in the first report; over half of those who had erosion from non-absorbable synthetic mesh needed it removed surgically, sometimes requiring two or three operations.
• Mesh contraction that causes vaginal shortening, tightening and pain is being reported more often.
• The mesh is causing more new cases of SUI.
• Abdominal surgery with mesh has fewer complications than transvaginal surgery with mesh.
• Transvaginal POP repair with mesh often restores anatomy, but does not improve the clinical benefit over traditional repair (abdominal repair).

The FDA made the following recommendations to women considering surgery for POP:

• Know the risks of transvaginal POP
• Realize that mesh surgery may require repeat surgery or surgeries due to complications
• Ask the surgeon about all surgical and non-surgical options
• Understand why the surgeon might be recommending mesh surgery for POP

After surgery women need to continue with their follow-up care. They should notify their doctor of any pain, complications, or symptoms. During a routine check-up, ask the surgeon if they received mesh for a POP repair if they do not know.

Contact an Experienced Transvaginal Mesh Attorney

If you are one of the thousands of women who have had problems with mesh surgery for POP, you deserve to be compensated for your pain and suffering. Our transvaginal mesh lawyers understand the many complications of this procedure and are experts in the law regarding POP surgery using mesh. Contact Flood Law Group, LLP for a free review of your case today.