If you are among the thousands of women who have had operations in which transvaginal mesh was implanted into your body and have developed serious health problems as a result you should be aware that the Food and Drug Administration has issued specific instructions to doctors about these devices because of increasing numbers of reports about these dangerous side effects.
The FDA acted after the agency confirmed that it had received thousands of complaints about transvaginal mesh failures after operations conducted to treat two common female health problems: pelvic organ prolapse and urinary incontinence.
Here is the actual language used by FDA officials about the transvaginal mesh problems and the procedures that should be followed by doctors:
- 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 complications.
- 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.
The complaints received by the FDA are the same that are contained in a wave of transvaginal mesh lawsuits that have been filed in state and federal courts and have become so voluminous that the federal court system has been forced to coordinate many of them before a single judge because of the similar allegations. The number of these lawsuits is expected to increase even further because transvaginal mesh lawyers are still accepting cases.
There is a staggering number of women who have had these operations and may be affected by severe side effects such as inability to have sex without pain, erosion, perforation of organs, abdominal pains, vaginal discharge and bleeding, infections and recurrences of the original problems.
The FDA estimates that there were about 300,000 operations in 2010 alone, in which women were treated with transvaginal mesh implants. The problem is so severe that the FDA issued a public safety alert informing both physicians and patients about these possible side effects.
Some studies have reported that in as many as 10 percent of these operations transvaginal mesh implant serious side effects were reported.
Among the companies named as defendants in these transvaginal mesh implant lawsuits are Ethicon, a division of Johnson & Johnson, American Medical Systems, Inc., Boston Scientific Corp., and C.R. Bard, Inc.