TVM Archives - 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.

Defective Transvaginal Mesh Device ObTape Causes Severe Health Problems

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Defective Transvaginal Mesh Device ObTape Causes Severe Health ProblemsObTape is a transvaginal mesh (TVM) device that is a vaginally inserted bladder sling used to treat women with stress urinary incontinence (SUI). Also known as ObTape Transobturator Tape, ObTape is manufactured by Mentor Corporation, a subsidiary of Johnson & Johnson.

After surgical implantation, though patients’ problems with SUI subsided, they began developing new complication involving ObTape. The surgically-implanted bladder sling began to cause serious injury and pain. Injuries and health complications related to the TVM ObTape include the following:

  •  vaginal bleeding
  • vaginal pain
  • painful intercourse
  • infection
  • scarring

Patients with ObTape also experienced erosion of the vaginal sling into their surrounding tissues, causing a severe amount of pain. In most cases, these patients required several surgical procedures to remove parts of the eroding and deteriorating vaginal mesh sling.

ObTape was approved by the U.S. Food and Drug Administration (FDA), though the FDA did not conduct a thorough investigation into the safety of ObTape. The reason for the FDA’s lack of investigation was due to ObTape’s structural and material similarities to existing and approved transvaginal mesh products. Essentially, the FDA placed ObTape on a fast track approval process. Furthermore, many transvaginal mesh products already on the market prior to ObTape’s approval turned out to be defective, causing many of the same severe health complications as ObTape.

Complaints filed with the FDA regarding serious side effects linked to surgical implantation of the ObTape vaginal sling began in 2004. Since then, there have been over 300 patients complaints filed with the FDA.

In its introduction of the device to the FDA, Mentor made a strong claim as to ObTape’s similarity to previously approved transvaginal mesh devices in an effort to receive clearance. However, upon receiving approval, Mentor marketed ObTape as a revolutionary transvaginal mesh device, with unique features that would decrease health complications related to TVM devices. Such marketing efforts proved to be false.

In an order provided by the United States District Court for the Middle District of Georgia Columbus Division, it is stated that plaintiffs in the ObTape Multi-District Litigation (MDL) experienced erosion of ObTape into their surrounding bodily tissues. Plaintiffs and expert witnesses involved in the ObTape Georgia-based MDL both claimed that Mentor did not warn patients and doctors about the inherent design flaw in ObTape causing it to erode, thus resulting in severe health complications for patients.

If you or a loved one has suffered immensely as a result of the Mentor ObTape vaginal sling, you amay be entitled to receive compensation for your losses.

For more information about filing an ObTape lawsuit, contact an experienced transvaginal mesh defective medical device attorney at Carey Danis & Lowe. Call 800.721.2519 for a free legal consultation regarding your ObTape case.