Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh Injury
Ethicon, a Johnson & Johnson Company, Makes Allegedly Dangerous Transvaginal Mesh Products
Johnson & Johnson's Ethicon division makes a number of transvaginal mesh devices, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Women who are implanted with these products are told that they will get relief for their conditions, but many say that the mesh only made their lives worse. One of the most common complaints, for instance, regards mesh erosion; this is when the mesh moves and cuts through the vaginal and pelvic tissues, causing immense pain. Surgery is performed to remove the mesh, but in some cases, scar tissue has already formed around the mesh, making it extremely difficult to remove. Some women needed multiple surgeries and still have not found relief.
Johnson & Johnson's Ethicon Stops Selling Four Transvaginal Mesh Devices
On June 4, 2012, it was revealed that Johnson & Johnson's Ethicon division would stop selling four types of transvaginal mesh implants. In a letter filed with the U.S. District Court for the Southern District of West Virginia, the company said it had asked the FDA for approval to stop selling the following devices:
- Gynecare TVT Secur system
- Gynecare Prosima
- Gynecare Prolift
- Gynecare Prolift + M
There is overwhelming evidence suggesting that transvaginal mesh devices are unsafe. For example, the FDA has reported a five-fold increase in injury reports related to the implants between 2008 and 2010. Despite the growing evidence, however, Ethicon and Johnson & Johnson claim that the decision to stop selling the mesh products had to do with commercial viability and not safety issues.
Jury Awards Woman $11.1 Million in Ethicon Vaginal Mesh Case Against Johnson & Johnson
In February 2013, Johnson & Johnson and Ethicon lost the first of some 4,000 Gynecare Prolift cases to go to trial. The jury awarded the plaintiff a total of $11.1 million; $3.35 million in compensation for her injuries, and $7.76 million in punitive damages against J&J.
Thousands of cases have been filed in the U.S. District Court for the Southern District of West Virginia over transvaginal mesh implants. So far, there are five multidistrict litigations (MDLs) pending in that court against Ethicon/Johnson & Johnson, Boston Scientific, C.R. Bard, American Medical Systems and Coloplast. Alleged injuries in these lawsuits include:
- Additional surgery and multiple revision surgeries
- Emotional distress
- Loss of ability to have sexual relations
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and suffering
- Spousal loss of consortium
Safety Issues with Transvaginal Mesh
Studies reviewed by the FDA found that roughly 10 percent of women who undergo surgery with transvaginal mesh will suffer from mesh erosion within 12 months. Other complications linked to the mesh implants include:
- Chronic vaginal damage, discharge and infections
- Exposure or extrusion of mesh, where mesh moves through vaginal tissue
- Feeling a lump in the opening or something protruding from the vagina
- Painful sexual intercourse
- Perforation of the bladder, intestines, bowels and blood vessels around the vaginal wall
- Recurring POP
- Recurring SUI
- Urinary problems
- Vaginal bleeding
- Vaginal pain
- Vaginal scarring and shortening
According to an FDA Safety Communication issued July 13, 2011, transvaginal mesh devices in general have been associated with serious complications. An expert advisory group convened by the FDA in September 2011 also expressed some concerns about the safety of transvaginal mesh.
A majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness, and benefits of transvaginal mesh devices in POP repair are not well established and needs to be followed up in the long term. The agency proposed reclassification of mesh devices that were used for POP repair to Class 3 from Class 2. This meant that surgical mesh designed for POP repair could no longer be approved via the FDA's lax 510(k) route, and manufacturers would need to do clinical tests to prove that their devices are safe and effective. This also meant that transvaginal mesh manufactured by Johnson & Johnson and other companies had not been clinically tested before being sold and implanted in thousands of women.
| Legal Help for Women Suffering from Transvaginal Mesh Complications
Our firm is representing numerous women in lawsuits over transvaginal mesh implants, including Ethicon transvaginal mesh products. To find out more about pursuing a lawsuit or to get free legal advice from one of our attorneys, please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.
More on Transvaginal Mesh
Boston Scientific Pelvic
C.R. Bard Painful Mesh
American Medical Systems's