Vaginal Mesh Lawsuits

Vaginal mesh, also known as surgical mesh or pelvic mesh, is a medical implant device used to treat pelvic organ prolapse and stress urinary incontinence. Thousands of patients had transvaginal mesh surgery under the guidance of their doctors. However, many patients suffered serious side effects and adverse complications.

If you had vaginal mesh surgery and suffered pain or injuries, you can file a personal injury lawsuit for financial compensation. Talk to an experienced defective medical device attorney about your legal options.

What Is Vaginal Mesh?

Transvaginal mesh surgery is used to reinforce the vaginal wall in cases of pelvic organ prolapse or to support the urethra for treating stress urinary incontinence. However, many of the pelvic mesh products have been discontinued or recalled because of safety concerns. In 2019, the U.S. Food and Drug Administration (FDA) ordered all manufacturers of transvaginal mesh to stop selling and distributing all products.

Surgical mesh implants have been around since the 1950s to treat hernias and other conditions. However, thousands of patients reported complications and serious side effects involving vaginal mesh. Since then, the FDA has increased oversight of mesh products.

Since 2016, the FDA has reclassified surgical mesh as a Class III medical device. This requires premarket approval and clinical test reviews for FDA approval. This was to address the serious safety concerns involving transvaginal mesh. 

What Is Pelvic Organ Prolapse?

Pelvic organ prolapse is when the tissues that hold the pelvic organs in place become weak or stretched. Pelvic organs, including the bladder, uterus, or rectum, put pressure on the vagina. Sometimes the prolapse or bulge can extend past the opening of the vagina.

Weakening of the muscle and tissue caused by aging, lack of estrogen, and obesity can cause uterine prolapse. Symptoms include vaginal pressure, problems with sexual intercourse, incontinence, and infections. Treatments include lifestyle changes or surgery.

What Is Stress Urinary Incontinence?

Stress urinary incontinence (SUI) is urinary leakage during physical activity. It results from a weakening of the pelvic floor and sphincter muscles. Activities that cause SUI include coughing, sneezing, laughing, exercising, or having sex. Muscle weakness can also occur with childbirth, injuries, certain medications, or obesity.

Treatment options for stress urinary incontinence include muscle training, behavioral changes, and surgery. Many patients try non-surgical options first before electing for surgery.

Side Effects and Adverse Events Associated with Transvaginal Mesh

The FDA keeps a database of adverse events reported by medical professionals and patients. There were thousands of adverse events associated with vaginal mesh products. These include reports of serious injuries and deaths.

Common adverse events involving transvaginal mesh implants include:

• Pelvic pain
• Vaginal mesh erosion
• Dyspareunia (painful sexual intercourse)
• Mesh protrusion
• Urinary problems
• Organ Perforation
• Vaginal scarring
• Emotional distress

In 2011, the FDA issued an update on the serious complications involving transvaginal placement of surgical mesh. This FDA report informed patients that serious complications are not rare. The FDA also reported no clear benefits of using vaginal mesh over traditional non-mesh repair.

Are There Medical Recalls for Vaginal Mesh Implants?

There have been numerous FDA recalls and discontinuations for pelvic mesh products. Transvaginal mesh products subject to recall and discontinuation include those made by the following brands:

• Boston Scientific Corp
• C.R. Bard
• Ethicon (Johnson & Johnson)
• American Medical Systems
• Coloplast

How Can a Medical Device Lawyer Help?

When manufacturers sell dangerous medical products, they pose a serious risk of injuries to patients. This includes defective surgical mesh devices. Mesh manufacturers are liable for injuries caused by defective designs, manufacturing defects, and failure to warn patients.

A defective drug and medical device lawyer can put you in the best position to recover compensation. Mesh injury damages can include medical expenses, lost income, revision surgery, pain and suffering, and punitive damages.

There have been thousands of transvaginal mesh lawsuits filed against medical device companies. A lawyer experienced in defective medical device lawsuits can review your case, explain your legal rights, and help you recover compensation.