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Physicians are growing more and more concerned over the potential risk of problems with vaginal mesh used to treat pelvic organ prolapse (POP), leading some to consider the use experimental until consistent data is available about long-term follow-up and possible complications.
In a Letter to the Editor published by the American Journal of Obstetrics & Gynecology on November 29, Dr. Anne M. Weber of Pennsylvania wrote that there is so little sound information on the health risks of pelvic organ prolapse vaginal mesh that it is impossible for patients to give truly informed consent for the surgery. As a result, Weber suggests that all use of surgical vaginal mesh implants should be governed under the same rules as experimental medical procedures.
A pelvic organ prolapse occurs when organs such as the bladder, uterus, bowel or rectum drop and push against the wall of the vagina. This happens when the muscles holding the pelvic organ in place become weak or stretched, often due to childbirth or surgery. Vaginal mesh may be used during prolapse surgery to support the muscle.
However, side effects of vaginal mesh for pelvic organ prolapse have been linked to a number of severe complications, including reports of infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Some women have also reported recurrences of the prolapse and the need for additional surgeries to attempt to remove surgical mesh that had eroded into the vagina.
In October 2008, the FDA issued a warning about vaginal mesh complications when used to treat pelvic organ prolapse and stress urinary incontinence. The agency indicated that more than 1,000 people have reported experiencing problems with vaginal mesh made by at least nine different manufacturers.
The FDA recommended that physicians obtain specialized training for various placement techniques and that they closely monitor patients for problems after vaginal mesh surgery. The regulatory agency also stressed that patients should be informed about the vaginal mesh risks, so that they understand that complications could seriously impact their quality of life.
In response to an article published in the American Journal of Obstetrics & Gynecology in August 2010, which stressed the importance of documenting informed consent in the face of the FDA warnings and mounting vaginal mesh lawsuits filed throughout the United States, Dr. Weber wrote that informed consent cannot be obtained for the use of vaginal mesh. She said patients should be made to understand the absence of data and the medical community’s uncertainty over the effects of vaginal mesh, and their consent should be a conscious decision to proceed anyway and reflected in their medical records.
“Sufficient data do not yet exist regarding the use of vaginal mesh procedures for pelvic organ prolapse,” Weber wrote. “Therefore, the use of vaginal mesh for prolapse should be treated as experimental, and patients should provide consent on that basis.”
The manufacturers of several different types of vaginal mesh face mounting litigation from patients who allege that they failed to adequately research their products or warn about the risk of complications.
In 2006, the Mentor ObTape vaginal mesh was removed from the market by Mentor Corporation just three years after it was introduced when a large number of women experienced severe problems. A number of Mentor ObTape lawsuits have been filed by women who alleged that the complication rate associated with the vaginal mesh could be as high as 17% to 18%. Earlier this year, Mentor ObTape settlements were reached in many of these vaginal mesh lawsuits.
C.R. Bard, Inc. also faces a number of lawsuits over problems with Bard Avaulta vaginal mesh. The Avaulta Anterior and Posterior Biosyntetic Support System, which is used to treat pelvic organ prolapse, has been linked to severe internal injuries, urinary problems, erosion and other complications. All federal Bard Avaulta vaginal mesh lawsuits, which allege that the implant was defectively designed, are currently consolidated for pretrial litigation as part of an MDL (multidistrict litigation) in the U.S. District Court for the Southern District of West Virginia.
Lawsuits over Ethicon Gynecare vaginal mesh have also been filed as a result of similar allegations. Most of the complaints have been centralized in New Jersey state court.