What is Transvaginal Mesh?
Transvaginal mesh (TVM) is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) in women. POP occurs when pelvic organs drop downward and bulge because of a weakness in the vaginal wall. SUI is a loss of bladder control and pain. These conditions can result as a woman ages, after a hysterectomy, giving birth or an injury. During surgery, transvaginal mesh is stretched across the vaginal wall or pelvic floor to support damaged organs and tissues. This type of mesh is widely referred to as both surgical mesh and transvaginal mesh.
Surgical Mesh Background
Surgical mesh is a Class II medical device regulated by the FDA. Gynecologists began using it to surgically treat SUI and POP in the 1990s. In 1996, the FDA cleared the first surgical mesh product for SUI. A surgical mesh product to surgically treat POP was approved in 2002.
As use of transvaginal mesh surgery increased over the years, so have reports of painful and debilitation complications. The FDA issued its first public health notification concerning complications in October 2008. The FDA upgraded the warning on July 13, 2011, after receiving reports of more than 3,800 complications since 2005. In September 2011, the FDA convened a panel to consider the safety of surgical mesh.
As a result, in January 2012, the FDA announced it was considering reclassifying surgical mesh from a Class II to Class III medical device. The agency also began requiring manufacturers to collect data on long-term surgical mesh complications. In June 2012, one of the largest manufacturers, Johnson & Johnson announced it would discontinue the product.
Surgical Mesh Complications and Treatment
Research shows that approximately 10 percent of women who have received transvaginal mesh surgery suffer from mesh erosion within 12 months. The FDA reports mesh erosion is one of the most frequent complications, along with pain, infection, bleeding, pain during intercourse, organ perforation and urinary problems. There have also been reports of emotional problems, vaginal scarring and neurovascular muscular problems.
Many of these conditions involve painful remedies, including intensive medical treatment, surgery and hospitalization. Complications may require multiple surgeries and even then, some conditions may not be treatable.Has There Been A Transvaginal Mesh Recall?
No. The FDA is considering reclassifying transvaginal mesh and began requiring manufacturers to collect data on the long-term complications. You can monitor transvaginal mesh recalls
through the FDA website, news media or on this web page.
Who Is Liable for Personal Injuries Caused by a Transvaginal Mesh Surgery
If you received transvaginal mesh surgery and sustained injuries
, the product manufacturer may be liable for pain and suffering, lost wages and past and future medical expenses. There are several transvaginal mesh manufacturers, including Johnson & Johnson, C.R. Bard, Tyco Covidian, Boston Scientific, American Medical Systems, Caldera, Ethicon, Gynecare, Mentor and Sofradim.
Other liable parties may include distributors, the hospital and the doctors who performed the procedure. What to Do If You Have Been Injured as a Result of Vaginal Mesh Surgery
Thousands of women have filed TVM lawsuits. If you have experienced injuries
, immediate action may be required to preserve your rights. Massachusetts has a Statute of Limitations which may restrict how long you can file a claim for compensation.
The product liability lawyers
at Breakstone, White & Gluck have the experience, expertise and resources to successfully handle your case. Cases of defective medical devices involving surgery are complex. Our attorneys have over 85 years combined experience handling cases involving defective products
, medical devices and medical malpractice
. We have an established network of experts in the field of product liability.
If you have been injured in a transvaginal mesh surgery, it is critical you act immediately. Contact us today for a free legal consultation at 800-379-1244 or 617-723-7676 or use our contact form
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