Transvaginal Mesh Complications Investigations
Stueve Siegel Hanson is investigating reports of complications associated with transvaginal mesh.
The FDA has issued a warning of the complications arising from mesh devices, which are surgically installed to help treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
While pelvic organ prolapse (POP) or stress urinary incontinence (SUI) can happen to any woman at any age, it is more likely to happen after specific events.
Researchers say an estimated 50 percent of all women between the ages of 50 and 79 have some form of prolapse. While less common in younger women, it’s still very possible. The events that lead to POP or SUI are varied and include childbirth, menopause and hysterectomy.
These mesh devices are surgically placed along and behind the vagina to support the uterus, the bladder, and other pelvic organs. Between 2005 and 2008, the FDA had received more than 1,000 reports of injured women. Because of this, the FDA has required that these manufacturers conduct extended safety trials on their vaginal mesh implants, and have also warned that the benefits of transvaginal mesh implants might not outweigh the risk of serious side effects from the device.
”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”
These injuries can occur following surgical placement of the transvaginal mesh and others can occur during the procedure itself. Vaginal mesh implants are known to cause:
- Mesh erosion through the vagina (also called exposure, extrusion or protrusion)
- Pain, infection and bleeding
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
If you are suffering from any of these conditions, it is essential that you seek medical help from your gynecologist or an urogynecological specialist as soon as possible.
FACTS ABOUT TVM
- Women were not told that these devices never went through clinical or human trials.
- Approximately 10 percent of women who receive transvaginal mesh implants experience mesh erosion within 12 months of surgery. More than half of reported complications require further surgery to remove the TVM implant.
- In 2010, manufacturers estimate more than 75,000 women had TVM surgery to repair pelvic organ prolapsed.
The complications resulting from surgical mesh often require invasive and costly medical treatments including surgical repair (sometimes involving the removal of the mesh device), IV therapy, drainage of hematomas or abscesses and blood transfusions. Despite all of the documented medical complications with TVM, federal regulators have yet to issue a recall of any TVM devices. Instead, manufacturers – many that are facing mounting lawsuits – have been voluntarily recalling their products. Boston Scientific’s ProteGen, which was the predicate for future generations of TVM, was pulled from the market in 1999 after the company was slapped with dozens of lawsuits. In 2006, Mentor Worldwide pulled its ObTape from the market and started a cascade of voluntary recalls from companies that include Johnson & Johnson’s Ethicon division and C.R. Bard.
The FDA recommends that patients:
- Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
- Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
- Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.
Women who have sought and undergone transvaginal mesh patch surgery did so because they had a problem for which they were seeking a solution; they were looking to get better, not worse. If you have experienced the serious side effects outlined above caused by transvaginal mesh and wish to receive additional information about your legal options, please call 1.888.756.6494.