From 2005 to 2008, the Food and Drug Administration received more than 1,000 reports of complications related to transvaginal mesh implants (TVMs). Many of these reports cited permanent health damage to the bodies of women who received the devices.
In October 2008, the FDA issued a public health notification informing healthcare providers of the risks of TVMs. The alert included the following recommendations.
- Obtain specialized training for each mesh placement technique, and be aware of its risks.
- Be vigilant for potential adverse effects 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.
The FDA’s warning doesn’t prohibit physicians from performing transvaginal mesh implants, but one hopes that the alert distributes shared knowledge and promotes awareness in the medical community, causing doctors to evaluate the profound risks that come with this procedure. After all, a fundamental principle of the medical profession is “First, do no harm.”
If you are suffering due to serious complications from a TMV, contact the Kentucky transvaginal mesh complications lawyers at Gray and White Law. Call us at 502-210-8942 or toll free at 888-450-4456 and set up a FREE, no-obligation consultation.