Transvaginal mesh (TVM) is a medical device that is surgically implanted in women to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These conditions typically occur after pregnancy and childbirth. In 2010, at least 75,000 women had POP repairs using transvaginal mesh.
The U.S. Food and Drug Administration (FDA) has issued safety warnings to patients and medical providers about serious complications associated with TVM implants. These advisories came after the FDA received more than 3,874 injury reports related to TVM from 2005-2010. Three of those were fatalities. The FDA is continuing to explore the safety and effectiveness of TVM.
The injury lawyers at The Driscoll Firm, P.C., are investigating national claims of injuries and adverse effects related to TVM implants. If you or a loved one has had a TVM procedure and suffers from pelvic or groin pain, especially during sex, vaginal bleeding, infections or urinary problems, you may have a legal right to compensation. Call The Driscoll Firm, P.C., at 800-305-9800 today to speak to an experienced injury attorney about your case.
What is Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)?
POP occurs when tissues holding in place the pelvic organs such as the bladder, uterus, rectum and bowel become weak or stretched. As a result, the organs bulge, or prolapse, into the vagina and sometimes beyond the vaginal opening. Thirty to fifty percent of women may experience POP in their lifetime, with two percent developing symptoms. SUI is the leakage of urine during physical activity such as coughing, laughing or sneezing.
Neither POP nor SUI is life-threatening. Women with these conditions often experience pain and pelvic discomfort, disruption of sexual and bodily functions, and an overall reduction in their quality of life. There are various treatment options. One option is to have a surgical mesh implanted through the vagina.
On July 13, 2011, the FDA issued a Serious Complications Update regarding the use of TVM for POP treatment. This followed a 2008 notice in which the FDA expressed concern over the number of problems reported by TVM patients.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with TVM used to repair POP – five times as many as the agency received from 2005 to 2007.
The FDA reviewed the scientific literature from 1996-2011 and found that TVM repair of POP does not improve symptomatic results or quality of life over traditional non-mesh treatments. The complications associated with TVM have not been linked to any single brand of mesh.
The most frequently reported complications include mesh becoming exposed or protruding out of the vaginal tissue (known as erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Men can experience pain during sexual intercourse if mesh erosion has occurred.
Contact a TVM Litigation Lawyer Today
The lawyers of The Driscoll Firm, P.C., are investigating national injury claims related to complications arising from the use of TVM. If you or a loved one has had a TVM implant and has experienced mesh erosion, bleeding, infection, pelvic pain or discomfort, urinary problems, pain during sexual intercourse or other problems, phone 800-305-9800 today to speak to a TVM litigation attorney about your case.
The Driscoll Firm has represented clients injured by dangerous pharmaceuticals and medical devices for more than a decade. In the last three years alone, we have recovered nearly $170 million in settlements for deserving clients.
For more information:
- July 13, 2011 – FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
- October 20, 2008 – FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence