In the United Kingdom, the Department of Health and the Medicines and Healthcare Products Regulatory Agency (MHRA) have been collaborating on a safety review of transvaginal mesh. Their collaborative effort results from an observed need to analyze the safety of these medical devices and to provide UK surgeons, gynecologists, and urologists with the most current and pertinent information regarding transvaginal mesh and transvaginal tape.
One recommendation made by the reviewing body was to create a registry of patients who have received surgical implantation of either transvaginal mesh or transvaginal tape. The UK health officials hope to develop such a registry in order to make the data available to surgeons for review of post-surgery patient health.
In conducting its own analysis of reports and data relating to the safety of transvaginal mesh and transvaginal tape, the U.S. Food and Drug Administration discovered that severe health complications related to the surgical implantation of these vaginal medical devices are not rare. Furthermore, in its scientific literature review, the FDA made the conclusion that there was no significant benefit in using transvaginal mesh versus a non-mesh device in treating patients with pelvic organ prolapse (POP).
Also, the FDA noted that the most commonly reported transvaginal mesh health complication is vaginal mesh erosion.
Transvaginal mesh and transvaginal tape are used to treat women suffering from stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Patients have reported to the MHRA in the UK and the FDA in the U.S. a number of severe health complications resulting from surgical implantation of transvaginal mesh. These serious health complications include vaginal bleeding, vaginal pain, painful intercourse, infection, scarring, transvaginal mesh erosion, and damage to surrounding tissues and organs.
Furthermore, some women must undergo revision or corrective surgeries following the initial implantation of their transvaginal mesh or transvaginal tape.
In the United States, transvaginal mesh and transvaginal tape manufacturers have pulled their defective medical devices off the market. Johnson & Johnson has removed four of its transvaginal mesh and transvaginal tape products from the market following increased reports of severe health complications related to these products. The Johnson & Johnson vaginal mesh recall included the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M.
If you or a loved one has suffered from a transvaginal mesh or transvaginal tape implant, do not suffer in silence, and learn more about filing a defective surgical mesh claim. To file a transvaginal mesh lawsuit, contact an experienced defective medical device lawyer at Carey Danis & Lowe.References: Defective Medical Device litigation, Transvaginal Mesh