What the U.S. Food and Drug Administration Says About Transvaginal Mesh
The United States Food and Drug Administration regulates thousands of medical devices and drugs that doctors and patients use every day. But one particular medical product —transvaginal mesh — has drawn special scrutiny from the FDA because of serious complications caused by the mesh.
It is a rare event for the FDA to issue a safety notification regarding any medical device. The FDA has issued two separate patient/physician safety warnings regarding transvaginal mesh, the first in 2008 and the most recent in July 2011.
Serious Complications Involving Transvaginal Mesh
Transvaginal mesh is a medical product made of synthetic or biologic material. It is generally used to reinforce or repair damaged or weakened tissue. In urogynecologic procedures, surgical mesh is implanted to reinforce the vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
In October 2008, the FDA issued a Public Health Notification regarding serious complications associated with transvaginal mesh placed through the vagina to treat pelvic organ prolapse and stress urinary incontinence. The FDA said from 2005 to 2007 there were more than 1,000 reports of complications involving mesh used to treat pelvic organic prolapse and urinary incontinence.
In July 2011, the FDA issued a Safety Communication expanding upon its earlier warning regarding transvaginal mesh. The FDA said it had received 2,874 additional reports of complications associated with transvaginal mesh devices from 2008 to 2010 and expressed concern that the number of reports of complications remained high. The FDA emphasized that serious complications associated with mesh for transvaginal repair of pelvic organ prolapse are not rare. “Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients and may expose patients to greater risk.”
From 2008-2010, the FDA said the most frequently reported complications for surgical mesh for pelvic organ prolapse repair include mesh extrusion through the vagina, pain, infection, bleeding, pain during sexual intercourse and organ perforation and urinary problems. The FDA also received reports of neuro-muscular problems, vaginal scarring and emotional problems. Many of the complications required additional medical or surgical treatment and hospitalization.
The FDA conducted a systematic review of scientific studies published from 1996 to 2011. Based on that review, the FDA said there was no clinical evidence that transvaginal POP repair improves symptomatic results or quality of life over traditional non-mesh repair methods. Among the FDA’s findings:
- The complications associated with transvaginal mesh “can be life altering for some women,” and that “[s]equelae (e.g., pain) may continue despite mesh removal.”
- “Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.”
The FDA summarized its findings from its review of the adverse event reports and applicable literature stating that it “has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.”
Manufacturers of medical devices have a legal responsibility to make and market products that are safe when used as intended. When the products cause injury, the manufacturers should be held accountable for the injuries their products cause.
Contact Transvaginal Mesh Injury Lawyers Today
If you or a loved one is suffering complications from defective transvaginal surgical mesh, turn to the experienced medical device attorneys at Blasingame, Burch, Garrard & Ashley, P.C.
Our mesh injury attorneys are familiar with the serious complications caused by transvaginal mesh products used for pelvic organ prolapse (POP) repair and treatment of stress urinary incontinence (SUI). We have taken transvaginal surgical mesh cases to trial and we have successfully resolved over one hundred transvaginal surgical mesh cases — more than any law firm in the nation.
We are proud of our role as advocates for women’s healthcare and our record of success in these cases. The surgical mesh lawyers at Blasingame, Burch, Garrard & Ashley, P.C. are available to answer your questions or provide a free case evaluation.
Call us toll-free at 877-312-1753 or use our online form. We have trained, experienced female consultants available to discuss your situation and circumstances confidentially.
