Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh Injury
Johnson & Johnson/ Ethicon Gynecare Transvaginal Mesh Complications Lawsuit
Johnson & Johnson/Ethicon Transvaginal Mesh Complications, Side Effects, Lawsuit | Transvaginal Mesh, Pelvic Mesh, Surgical Mesh, Pelvic Sling | Lawsuits, Lawyer, Attorney | Side Effects: Bleeding, Pelvic Pain, Infection, Surgical Mesh Infection, Vaginal Epithelium Erosion, Erosion of Vaginal Tissue, Mesh Erosion, Pain, Incontinence, Urinary Problems, Prolapse, Bowel Perforation, Bladder Perforation, Blood Vessel Perforation, Pressure or “fullness” in the lower abdomen, Dyspareunia, Painful Sexual Intercourse, Vaginal bleeding Vaginal infections, Vaginal pain not related to intercourse, Vaginal Scarring, Neuropathic Numbness Or Weakness | Impaired Healing, Complications, Revision Surgery For Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI)June 5, 2012:
BREAKING NEWS: Johnson & Johnson's Ethicon to Stop Selling Four Transvaginal Mesh Devices
On June 4, 2012, it was revealed that Johnson & Johnson's Ethicon, Inc. division would stop selling four transvaginal mesh implants: Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+. In a letter filed with the U.S. District Court, Southern District of West Virginia, where Ethicon and Johnson & Johnson are named in hundreds of transvaginal mesh injury lawsuits, the company said it had asked the U.S. Food & Drug Administration (FDA) for approval to stop selling the four devices. According to Ethicon it will stop selling the products over the next three to nine months, with a goal of ending sales worldwide by the first quarter of 2013.
Transvaginal mesh devices, including those marketed by Ethicon, have been linked to serious injuries in women, including infections, pain and other complications. In January 2012, the FDA ordered makers of the implants to study their risks in patients. Between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. Yet in spite of the controversy surrounding transvaginal mesh products, Ethicon has insisted that its decision to stop selling the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+ was not motivated by safety concerns. Rather, the company said the decision was made due to concerns about the products’ commercial viability “in light of changing market dynamics," and continues to maintain that transvaginal mesh “is and remains an important treatment option for patients.”
Johnson & Johnson, battling lawsuits over transvaginal mesh implants
October 20, 2011: Johnson & Johnson, the world's second-biggest health-care products make, is battling lawsuits over a vaginal implant based on a similar device pulled from the market more than a decade ago for safety reasons, reports Bloomberg News. Read about Johnson & Johnson Vaginal Mesh...
Gynecare products manufactured by Johnson & Johnson's Ethicon unit are among the transvaginal surgical mesh implants or pelvic slings that have been implanted in thousands of women during urogynecologic procedures to repair pelvic organ proplase (POP) and stress urinary incontinence (SUI). Unfortunately, many vaginal mesh and sling devices manufactured by Johnson & Johnson/Ethicon have been associated with a high rate of complications, and have left some recipients coping with permanent pain and disability. Women throughout the country have filed Gynecare transvaginal or pelvic mesh lawsuits against Johnson & Johnson and Ethicon seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, pain and emotional distress.
Johnson & Johnson/Ethicon Gynecare transvaginal mesh/sling products that have been the subject of lawsuits and adverse event reports include those sold under the names:
- Gynecare Gynemesh
- Gynecare Prolift
- Gynecare Prolift+M
- Gynecare Prosima
- Gynecare TVT
Gynecare surgical mesh and pelvic sling implants are intended to act as a hammock to support prolapsed organs and improve symptoms associated with POP and SUI. These transvaginal surgical mesh products are implanted during POP repair to provide support for the female’s pelvic organs when they drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. Johnson & Johnson/Ethicon Gynecare surgical mesh and pelvic sling devices can be implanted transvaginally to repair prolapse of the bladder (cystocele), top of the vagina (apical prolapse), uterus (procidentia), rectum (rectocele), bowel (enterocele) and urethra.
Gynecare vaginal mesh/sling products may also be used to repair SUI, which occurs as a result of weakened pelvic muscles that support the bladder and urethra. The condition is most common in women who have had multiple pregnancies and vaginal childbirths, and who suffer from pelvic organ prolapse (POP).
Johnson & Johnson Ethicon Gynecare Transvaginal and Pelvic Mesh Adverse Events and Failures
Adverse events associated with Gynecare transvaginal mesh and pelvic slings may include:
- Erosion of the mesh through the vaginal tissue
- Exposure or extrusion of mesh, which can require multiple surgeries
- Feeling a lump in the vaginal opening or something protruding from vagina
- Painful sexual intercourse
- Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
- Recurrent Pelvic Organ Prolapse (POP)
- Recurrent Stress Urinary Incontinence (SUI)
- Urinary problems
- Vaginal bleeding
- Vaginal chronic drainage, discharge and infections
- Vaginal pain
- Vaginal scarring and shortening
To correct Gynecare vaginal mesh and pelvic sling injuries, victims must usually undergo at least one, if not several, additional surgical procedures to remove the device. Unfortunately, even after repeated surgeries, transvaginal mesh complications cannot always be reversed, and many women will continue to suffer with vaginal pain and an impaired quality of life.
Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh and Pelvic Sling Lawsuits
Victims of Gynecare vaginal surgical mesh implant and sling failures who file a transvaginal mesh lawsuit may be able to collect damages for:
- Additional surgery and multiple surgical revisions
- 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
It is expected that more women will file Gynecare transvaginal mesh and pelvic sling lawsuits, especially as the U.S. Food & Drug Administration (FDA) continues to scrutinize the safety risks, complications and failures of surgical mesh implanted transvaginally to treat POP and SUI. Lawyers at our firm who specialize in defective medical devices are offering free lawsuit evaluations to victims of Johnson & Johnson/Ethicon Gynecare vaginal surgical mesh implant failures. To learn how you may be able to recover damages for your pelvic mesh injuries, emotional distress, and pain and suffering, we urge you to contact our transvaginal mesh failure lawyers today for your free consultation.
News about Transvaginal Mesh
According to an FDA safety communication issued on July 13, 2011, 2,874 new reports of complications - 1,503 involving POP repairs and 1,371 involving SUI repairs - associated with transvaginal surgical mesh procedures were made to the agency from January 2008 through December 2010. Studies reviewed by the FDA also indicated that roughly 10 percent of women who undergo a procedure involving transvaginal placement of surgical mesh will suffer mesh erosion within 12 months of surgery. More than half will need to undergo an additional surgery to remove the mesh, but in many of these cases, the excision procedure will not resolve their mesh failure symptoms. The FDA was unable to find conclusive evidence showing that transvaginally placed mesh in POP repair is more effective than traditional non-mesh repair in all patients with POP and that “it may expose patients to greater risk”.
Public Citizen, the consumer advocacy group founded by Ralph Nader, petitioned the FDA on August 25, 2011 to recall transvaginal mesh products due to safety considerations and their association with painful and debilitating complications.
In an "Executive Summary" released on August 31, 2011, the FDA said it "believes that vaginal placement of surgical mesh for Pelvic Organ Prolapse (POP) repair inherently introduces risks of complications that are unique to the mesh itself."
During a meeting convened in September 2011, a majority of outside experts on the FDA's Obstetrics & Gynecology (OB/GYN) Medical Device advisory panel agreed that the safety, effectiveness and benefit of transvaginal mesh devices in POP repair has not been well established and warrants long term prospective follow-up of patients. The FDA is considering a proposal to reclassify transvaginal mesh devices used in the repair of POP to Class 3 from their current Class 2 designation, thereby making surgical mesh for POP repair ineligible for the FDA’s less-stringent 510(k) approval protocols, and require that such devices be subjected to human clinical trials in order to gain FDA approval for this use.
Legal Help for Victims of Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh Complications
If you or a loved one suffered painful injuries as a result of POP or SUI repair that involved a Johnson & Johnson/Ethicon Gynecare vaginal mesh implant or pelvic sling, you may have valuable legal rights. To learn more about obtaining compensation for transvaginal mesh injuries, please fill out our online form, or call 1 800 LAW INFO (1-529-4636) today.