Gynecare Prosima Archives - Carey Danis & Lowe

UK Health Organizations Conduct Study on Transvaginal Mesh Safety

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

UK Health Organizations Conduct Study on Transvaginal Mesh SafetyIn 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.

Johnson & Johnson Stops Sales of Gynecare Transvaginal Mesh

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

In June 2012, Johnson & Johnson made the decision to remove their defective transvaginal mesh (TVM) medical device from the global market. Though the medical device manufacturer cites future market performance as being the reason for the discontinuation of sales, their decision comes as there is an ever-increasing number of lawsuits citing links between their transvaginal mesh devices and severe health complications.

According to a Reuters report from June 2012, there are currently over 1,000 transvaginal mesh lawsuits  filed against Ethicon Inc., the subsidiary of Johnson & Johnson responsible for the manufacture of the defective transvaginal mesh. The Johnson & Johnson Gynecare vaginal mesh lawsuits are being heard by a federal judge in West Virginia and a state judge in New Jersey.

As a result of surgical implantation of Johnson & Johnson’s Gynecare Prolift transvaginal mesh devices, patients have claimed organ injury, bleeding, infections, and severe pain. Transvaginal mesh is used to treat women suffering from pelvic organ prolapse or stress urinary incontinence, both health conditions resulting from muscle weakening in the pelvic region.

According to a statement made by an Ethicon spokesperson, the medical device manufacturer has made a plan to pull several Gynecare products from the global market, including the Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M, all transvaginal mesh devices.

Back in January 2012, the U.S. Food and Drug Administration ordered transvaginal mesh manufacturers, such as Ethicon and Johnson & Johnson, to begin studying patients with surgically implanted transvaginal mesh to better understand the safety of such products. As Johnson & Johnson has made the decision to pull four of their surgical mesh devices from the global market, the company has stated that it should no longer have to conduct studies of patients with their surgical mesh implants.

If you or someone you love has undergone surgery to receive one of the discontinued Johnson & Johnson transvaginal mesh devices, and as a result, has suffered enormously from physical pain and financial losses, you and your loved one may be entitled to receive compensation. For a free legal consultation about your Johnson & Johnson Gynecare transvaginal mesh case, contact an experienced defective medical device lawyer at Carey Danis & Lowe today by calling 800.721.2519.