If you or a loved one had transvaginal mesh surgery, you may be eligible to file a lawsuit for compensation from the manufacturer. The US Food and Drug Administration (FDA) issued a statement warning of serious complications associated with the surgical mesh used in transvaginal placement. In addition, the FDA has warned that transvaginal mesh may not be more effective in certain situations than non-mesh repairs and that it may expose patients to a greater risk of adverse side effects.
If you or a loved one suffered complications, please call 713-850-8600. A transvaginal mesh lawyer at our firm can help you pursue the compensation you need.
What is Transvaginal Mesh?
Transvaginal mesh is a medical device used to repair weakened or damaged tissue and placed through the vagina. It is made from either porous or non- porous absorbable synthetic material or absorbable biologic material.
Transvaginal mesh is used to repair pelvic organ prolapse by being permanently implanted to reinforce the weakened vaginal wall. It is also used to treat stress urinary incontinence. The transvaginal mesh kits manufacturers marketed to urologists and gynecologists promised an increase in surgical volumes due to their quick-and-easy application, thus increasing profits. This despite the lack of trials testing the safety of these medical devices and their application.
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the pelvic floor can no longer support the pelvic organs including the vagina, cervix, uterus, bladder, urethra, and rectum. The muscles and tissue of the pelvic floor may weaken with age or because of labor or childbirth. Other causes of POP are obesity, frequent constipation, or genetics. Symptoms of POP include pelvic pain, pressure, and bulging of tissue or organs.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is the most common type of urinary incontinence for women. They experience urine leakage during physical activity or when coughing or sneezing. SUI occurs when the pelvic muscles supporting the bladder and urethra become weakened. Pregnancy, childbirth, aging, obesity, or pelvic surgery can cause this weakness.
Four Issues Revealed by the FDA Review of Transvaginal Mesh
There have been thousands of reports of complications associated with the use of transvaginal mesh to repair POP and SUI. As a result, the FDA conducted a review to evaluate the safety and effectiveness of transvaginal mesh. The review has shown that using transvaginal mesh for POP is no better than non-mesh repair. The FDA is still evaluating the results for SUI transvaginal mesh surgeries due to the high volume of incidents.
The review revealed these four issues:
- Transvaginal mesh POP repair increases patient risks not found in traditional non-mesh POP repair.
- Transvaginal mesh surgery carries a higher risk of mesh complications than abdominal mesh surgery for POP repair.
- There is no evidence of benefits from using transvaginal mesh to support either the top or back wall of the vagina compared to non-mesh treatment.
- There may not be any better symptomatic results when using transvaginal mesh to strengthen tissue between the bladder and vagina compared to traditional non-mesh POP repair.
The Horrible Side Effects of Transvaginal Mesh
The most commonly reported complication from transvaginal mesh surgery is the. This may require multiple surgeries to repair with sometimes less than satisfactory results.
Another complication from the use of transvaginal mesh is mesh contraction (shrinkage). This can result in vaginal shortening, tightening, and pain. Both mesh erosion and mesh contraction may cause severe pelvic pain as well as interfere with the woman’s ability to engage in sexual intercourse.
Other complications include:
- Protrusion of vaginal mesh through the soft tissues
- Infection in the treated area
- Painful intercourse
- Perforated organs
- Difficulty urinating
These side effects can be debilitating and frequently result in additional surgeries to repair the damage caused by the mesh. Unfortunately, many of these complications may persist even after removing the mesh, causing a lifetime of chronic pain.
Between 2005 and 2010, there were around 4,000 complaints filed with the FDA which led the agency to release a public safety update explaining that complications after treatment of POP with transvaginal mesh products are not rare. In an April 2014 news release, the FDA has announced that it will crack down on all transvaginal mesh products changing their status from moderate-risk devices to high-risk devices because of the elevated risks they pose.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health.
Because of the serious injuries many women have suffered after transvaginal surgery, they are filing lawsuits against the various manufacturers of the mesh. Many had to undergo additional surgery to repair the damage done by vaginal mesh. The very same “miracle product” that promised to ease the discomfort and embarrassment many women experience, now has been blamed for organ perforation, inability to enjoy sexual relations, and even death in some cases.
What Action Should You Take if You Have Had Transvaginal Mesh Surgery?
If you had a transvaginal mesh surgery with no complications, there is no need to take any action. However, if you are like the thousands of women who have symptoms such as persistent vaginal bleeding, discharge, pelvic pain, or pain during sex, first contact your medical professional and then call one of our transvaginal mesh lawsuit lawyers to see if you might have a valid claim against the manufacturer of the mesh. Complications from transvaginal mesh surgery are linked to several brands of mesh which may qualify you to file a claim.
Your free consultation will help to determine whether you have a strong claim for compensation. If you had symptoms of mesh erosion or mesh contraction after your transvaginal mesh surgery, you may be advised to file a lawsuit. Our transvaginal mesh attorneys will advise you on your next step and work with you every step of the way. Call 713-850-8600.
The Time to File a TVM Lawsuit is Now – Speak With a Transvaginal Mesh Lawsuit Lawyer
Judges have already awarded millions to victims of these defective products. Don’t miss out on filing your claim. There may be a time limit after your injury to submit your case.
If you suffered a serious side effect related to your transvaginal mesh surgery, contact our transvaginal mesh lawyers now to start your claim. You have the right to request compensation for your injuries and the no-obligation call for more information is free.
Call us now toll-free at 713-850-8600 or fill out the contact form on this page to request your free consultation with a transvaginal mesh lawsuit lawyer.