Lieff Cabraser Heimann & Bernstein, LLP

Lieff Cabraser represents women alleging serious side effects and injuries from synthetic vaginal mesh. This surgical mesh, made of polypropylene, is used to treat pelvic organ prolapse or POP, an often painful condition that affects thousands of women annually. POP occurs when the connective tissue and muscles that surround and support the pelvic organs have grown weak or have stretched, often after childbirth.

Traditional surgery to treat POP uses a woman's own tissue to support the organs. When synthetic mesh is used, it is implanted transvaginally (through incisions and punctures made through the wall of the vagina) to reinforce tissues around the descended pelvic organ. It may be inserted using an anterior or posterior approach.

Surgical mesh is also used to treat urinary incontinence.

March 2012 Update: FDA Orders Transvaginal Mesh Manufacturers to Conduct Safety Trials and Patient Advocacy Group Calls for Vaginal Mesh Recall

On January 4, 2012, the FDA ordered Johnson & Johnson, C.R. Bard, Boston Scientific, and 30 other manufacturers of surgical mesh to conduct new studies on the safety and effectiveness of vaginal mesh when used to treat pelvic organ prolapse and stress urinary incontinence. The FDA letter follows on a recommendation from an FDA advisory panel in September 2011 that mesh for pelvic organ prolapse be reclassified as a high-risk medical device.

"The FDA's order reflects increasing reports of series injuries caused by certain vaginal mesh products, and the fact that the manufacturers have marketed these products heavily without conducting adequate human studies or providing adequate risk information," stated Lieff Cabraser attorney Lexi J. Hazam, who represents women nationwide in vaginal mesh side effects lawsuits.

Last year, the public interest and safety group Public Citizen called upon the FDA to recall non-absorbable transvaginal surgical mesh. Public Citizen stated that the non-absorbable meshes “should be recalled because they offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm."

Vaginal Mesh Complications and Side Effects

In past three years, the FDA has received over 1,500 reports of complications with surgical mesh devices used to repair POP, and over 650 patients have filed vaginal mesh lawsuits. During this time, there were seven reported deaths associated with POP repairs, three of which were related to the mesh placement procedure. The mesh products are made by several companies including C.R. Bard Inc., Boston Scientific Corp. and Johnson & Johnson.

The most common complications for surgical mesh devices used to repair POP include:

• vaginal mesh erosion – tissue between the mesh and the lining of the vagina breaks down and the mesh becomes exposed on the surface of the vagina;
• vaginal scarring;
• contraction or shrinking of the mesh;
• infection; 
• neuro-muscular problems; and
• onset or resurgence of urinary problems such as incontinence.

In some cases, the complications led to severe pelvic discomfort and pain, additional "revision" surgeries to try to excise the mesh, and permanent life-changing injuries.

Contact Lieff Cabraser

If you or a family member has suffered an injury as a result of the operating room use of surgical mesh, please feel free to contact a personal injury attorney at Lieff Cabraser for a free, no-obligation review of your case. Or, if you prefer, you can telephone attorney Heather Foster directly at 1 800-541-7358.