Transvaginal mesh, also known as surgical mesh, is used after a hysterectomy is performed to correct or prevent the top of the vagina from collapsing on itself. A hysterectomy is a surgical procedure which removes the uterus from the body.
Chances of the collapse increase after undergoing a hysterectomy procedure because the support that was once provided by the uterus is gone. After the procedure, the mesh, which is made from polypropylene, is then attached to the top of the vagina and the connective tissue around the sacral bone which keeps the vagina in place. In the past, mesh used to reinforce vaginal tissues after hysterectomy has been placed into the pelvic cavity through an abdominal incision. However, more surgeons have begun to use transvaginal placement of mesh, inserting the mesh through the vagina with specialized tools which allows for the avoidance of an abdominal incision.
There are six main companies in the United States that market transvaginal mesh:
- C.R. Bard
- Ethicon/Johnson & Johnson
- American Medical Systems
- Boston Scientific
- Proxy Biomedical, Ltd.
- Caldera Medical (as of June 2015)
In 1996, the Food and Drug Administration (FDA) approved the transvaginal mesh device which was manufactured by Boston Scientific. However, the mesh was approved without studies being conducted and without ever being implanted in a human vagina. The approval was issued by way of the FDA’s 510(k) method which allows devices to enter the market without a substantial amount of clinical testing as long as the manufacturer can show that it is similar enough to a previous device (also known as a predicate).
At one time, the insertion of mesh through the vagina was thought to provide benefits over other types of surgeries. However, a growing amount of evidence suggests that transvaginal mesh can cause serious health problems.
Between 2008 and 2010, over 1,500 complaints and seven deaths were reported as being attributed to transvaginal mesh which was five times as much as reported between 2005 and 2007.
In October 2008, the FDA released a Public Health Safety Notification that served to warn the public about complications of transvaginal mesh. Less than three years later, in July 2011, the FDA issued an update stating that the previously reported complications were not rare. In January 2012, the FDA ordered all manufacturers of transvaginal mesh to conduct after market studies.
Later in 2012, over 650 lawsuits were filed based upon claims that the mesh caused a myriad of painful injuries. The cases were then consolidated into one lawsuit by the U.S. Judicial Panel against Johnson & Johnson’s Ethicon Inc., American Medical Systems and Boston Scientific.
Johnson & Johnson has been named a defendant in more transvaginal mesh lawsuits than any other manufacturer and has been forced to pay out millions in settlements and losing verdicts.
C.R. Bard, another transvaginal mesh manufacturer, has over 10,000 cases pending but recently paid out over $200 million to settle 3,000 cases.
American Medical Systems paid over $1.5 billion to settle its cases which included over 30,000 lawsuits.
Boston Scientific has roughly 20,000 outstanding lawsuits but has settled over 6,000 lawsuits for an estimated $457 million.
A California court recently approved a $12.3 million deal to settle a number of insurance claims over injuries caused by Caldera Medical’s transvaginal mesh.
Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician’s neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.
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