Transvaginal Mesh (TVM) is a medical device used to repair Pelvic Organ Prolapse (POP), and/or Stress Urinary Incontinence (SUI) in women.
The FDA raised its first red flag regarding Transvaginal Mesh (TVM) on October 20, 2008. While claims of severe injury from women across the US were far from validated, the reality of a growing number of patients suffering severe post-operative injuries associated with TVM became undeniable.
The FDA issued a Public Health Notification to healthcare providers regarding the cautionary use of TVM, citing 1000 reported adverse events (complications) between 2005 and 2008 from nine manufactures.
By December of 2010, an additional 2,784 reports forced the FDA to reclassify the use of TVM as high risk in an updated alert on July 13, 2011 and concede that their previous statement regarding severe injuries as “rare” was incorrect. The updated alert also recommended physicians obtain specialized training for mesh placement techniques, be vigilant in post-operative evaluation for infection and other known signs of failure, and carefully consider the benefits of alternative, more traditional abdominal procedures. The FDA also emphasized physician disclosure of the risks and alternative surgical procedures available to patients prior to using TVM.
Transvaginal Mesh Complications
With an estimated half-million surgeries for POP and SUI occurring in 2010 alone using TVM products (sometimes referred to as “vaginal slings”), the lives and health of countless women continue to be at risk, and for many, will result in permanent, irreversible damage.
Patients with complications following TVM implants routinely require additional, often multiple surgeries, IV therapy, blood transfusions, and drainage of abscesses caused by infection.
Their horror stories include acute post-operative pain and in some cases, life-threatening septic infection, scarring, erosion and eventual perforation of the vaginal wall, organ perforation, uncontrolled bleeding, and painful intercourse (if capable of having sexual relations at all), as well as the re-occurrence of incontinence and prolapsed organs.
Once the mesh is surgically woven into the vaginal wall, full removal during repair or reconstructive surgery is almost always impossible.
Today, more than thirty manufacturers of TVM continue to defend the safety of their products, including Johnson & Johnson, who currently faces over six hundred (600) alleged defective product lawsuits. J&J recently announced their decision to halt sales of four out of the company’s five TVM product lines (Secur, Prosima, Prolift and Prolift+M ) by early 2013 citing, in part, a competitive and declining world market.
Plaintiff’s attorney Kerrie Webb considers Johnson & Johnson’s statement regarding ‘safety concerns playing no role in their decision’, suspect, as well as irresponsible.
“The complete disregard for tragic and preventable harm to women throughout the US as a result of their dangerous product is apparent given their decision to allow mesh products already lining hospital shelves to remain available for implant, rather than voluntarily recalling it as a precautionary measure,” says Webb.
Patients have also brought suit against other TVM manufacturers, including C.R. Bard and Endo Health Solutions, and Boston Scientific.
The medical device attorneys at Kershaw, Cutter & Ratinoff, LLC, are committed to protecting the rights of women who have been harmed by TVM products and to prosecuting their claims to the fullest extent of the law.
Due to the statutes of limitations regarding any defective medical device claim, which varies individually by state, it is vital that anyone who suspects they may have been injured by TVM products seek consultation with an attorney experienced in defective medical devices as soon as possible.
In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.
If you or a loved one are experiencing problems with a transvaginal mesh medical device, contact one of our medical device attorneys to talk about your potential case. Please fill out and submit the contact form on this page for a free and confidential case evaluation or call us toll-free at (888) 997-5170.