Surgical mesh, used in female patients to secure pelvic organs and repair weakened tissue, may need additional evaluation to determine whether it is safe for use. In two years, from 2008 to 2010, 1,500 women reported problems stemming from the use of transvaginal mesh (TVM). That number is more than five times the number of complications reported between 2005 and 2007.
As the number of women who've reported problems with erosion and infection, among other complications, has risen dramatically, the Food and Drug Administration (FDA) is considering reclassifying the mesh so that clinical trials are necessary prior to FDA approval for its use. Based on this history, transvaginal mesh can be considered a dangerous product and women should be fully aware of the potential for additional problems associated with the surgical mesh before undergoing a TVM procedure.
Common Uses of Surgical Mesh in Women
Surgical mesh is used for any number of procedures. The transvaginal placement of surgical mesh is used in women to prevent or improve pelvic organ prolapse (POP) or stress urinary incontinence (SUI) or otherwise give support to weakened tissue.
Both POP and SUI are mainly seen in women who've gone through childbirth. The FDA reports that 30 to 50 percent of women will be affected by SUI in their lifetimes. A vaginal delivery can stress a woman's pelvic organs to the point that they may drop or prolapse (protrude) into the vaginal wall. TVM is then used to strengthen these areas.
Complications Related to the Use of Transvaginal Mesh
Erosion of the surgical mesh or infection at the site of placement are two complications that have been reported by women who've undergone a procedure to place the surgical mesh transvaginally. Women have also reported experiencing pain during intercourse, bleeding, pain and discharge, among other side effects after TVM is inserted.
The problems caused by transvaginal mesh have required some women to undergo multiple revisionary surgeries or to have the mesh removed entirely. Of course, with additional surgeries comes additional recovery time as well as medical expenses that may or may not be covered by an insurance provider.
Rather than improving a woman's quality of life, the use of TVM to treat POP or SUI has, for some women, actually caused a decline in their quality of life. From pain and suffering and emotional distress to a loss of consortium and loss of ability to engage in sexual acts with a spouse or partner, TVM may do more harm than good.
FDA Request For Additional Studies of TVM Safety
At the beginning of January, 35 companies received a request from the FDA to conduct 3-year studies to more fully examine the negative side effects women are experiencing from the transvaginal placement of surgical mesh.
The FDA is considering whether makers of the surgical mesh, such as Boston Scientific and Johnson & Johnson, should be required to go through a more stringent approval process for TVM. Surgical mesh has been in use since the 1950s, but the transvaginal placement of it for treatment of SUI and POP didn't begin until the 1990s. Makers of the vaginal mesh were able to receive approval without clinical safety studies through the FDA's 510(k) process which allows for a device that is similar to an already-approved device to be sent to market.
If You've Experienced Side Effects of TVM Contact a TVM Lawyer
The FDA's focus on the dangers of transvaginal mesh and the side effects of the dangerous product should alert women across the country who've had the procedure to the possibility that it's removal may be their next step toward a better life. For those who've undergone revisionary surgery, removal surgery or otherwise have suffered because of transvaginal mesh, Missouri transvaginal and pelvic organ prolapse mesh attorneys can help you fight for compensation for your injuries and expenses.
