Many women who underwent operations to treat pelvic organ prolapse or stress urinary incontinence and had transvaginal mesh implants may not be aware that such operations could cause serious side effects adversely affecting their health.
They also may not be aware that the Food and Drug Administration issued a Public Health Notification in 2011 about serious health concerns involving transvaginal mesh and issued a list of recommendations for doctors to follow in connection with this medical device.
Here is a list of the recommendations that the FDA made to physicians in connection with transvaginal mesh:
- Obtain specialized training for each mesh placement technique, and be aware of its risks.
- Be vigilant for potential adverse events from the mesh, especially erosion and infection.
- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.
Problems with transvaginal mesh have been widespread. Thousands of transvaginal mesh lawsuits have been filed against such companies as C.R. Bard, American Medical Systems, Boston Scientific, Ethicon, Coloplast, and Cook Medical, according to court files.
Many of the federal lawsuits have been consolidated into what are called multidistrict litigations in U.S. District Courts under specially designated judges.
These judges preside over pre-trial evidence gathering and other legal actions and are empowered to choose certain lawsuits as bellwether, or test cases, in which lawyers for both sides can test the strengths and weaknesses of their cases.
It is also not unusual for judges in such litigations to grant class-action status to the cases because they contain similar allegations against the same defendants.
There have been some bellwether cases already, including one in which a jury awarded a woman about $2 million dollars in damages for the injuries and pain and suffering she claimed as a result of a defective transvaginal mesh product.