The FDA Proposes to Reclassify POP and Instrumentation
The FDA has proposed to reclassify transvaginal pelvic organ prolapse (POP) repair from a class II (moderate risk) device to a class III (high-risk) device.
The FDA has expressed concern about the safety and effectiveness of the current controls and whether they provide reasonable assurance to patients when the surgical mesh is used.
In additional to the POP class proposal, the FDA is also proposing a class change from a I to a II for urogynecologic surgical mesh instrumentation.
What is Transvaginal Pelvic Organ Prolapse?
Mesh used is a synthetic and porous implant used to treat the prolapse, or “drop,” of the pelvic organs, also called pelvic organ prolapse, or POP. A bladder prolapse is the most common organ problem that is treated with transvaginal mesh.
What are the Transvaginal Mesh Implant Side Effects?
Thousands of women reported experiencing complications after the implant of transvaginal mesh devices. These complications include:
- Neuromuscular problems
- The mesh eroding through the vagina
- Vaginal scarring or shrinkage
- Urinary problems
- Infection
- Bleeding
- Pain, especially during intercourse
- Organ perforation
- Recurrent prolapse
The transvaginal mesh lawyers of Zoll, Kranz & Borgess, LLC advocate the importance of drug and medical device safety for all consumers. Please call an attorney toll-free at (888)841-9623 if you or a loved one has experienced adverse side effects from transvaginal mesh.
Source: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395192.htm