Johnson & Johnson’s Gynecare Prolift is a sling-like vaginal mesh device that is used to repair Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP), two common conditions faced by hundreds of thousands of women after pregnancy. Unfortunately, thousands of women have been injured by transvaginal mesh. Gynecare Prolift side effects include life-threatening infection, chronic pain during sexual intercourse, erosion of the device into the vaginal wall, perforation of internal organs, scarring, nerve damage, and more.
Do I Have a Gynecare Prolift Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by Gynecare Prolift vaginal mesh, you should contact our lawyers immediately. You may be entitled to compensation by filing a Gynecare Prolift Lawsuit.
Johnson & Johnson’s Ethicon unit created the Gynecare Prolift Transvaginal Pelvic Floor Repair System back in 2005. It is a hammock-like device that a surgeon implants in the pelvis through small incisions in the vagina. It is used to help support weakened pelvic muscles. This can help repair two conditions, Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), which are common complications of pregnancy and aging. Hundreds of thousands of women suffer from these conditions and have undergone pelvic mesh surgery as treatment.
The Gynecare Prolift has been withdrawn from the U.S. market since June 2012. The withdrawal is voluntary, and it is not a recall. Johnson & Johnson cited declining sales and changing market dynamics as the reason for the withdrawal, and not safety concerns with the device.
Gynecare Prolift and the FDA
The Gynecare Prolift has faced the brunt of the criticism surrounding the safety of transvaginal mesh. The problems began in August 2007, when the FDA sent J&J a warning letter for marketing the Gynecare Prolift without FDA clearance. The FDA ordered J&J to immediately halt marketing the device. Despite this warning, J&J continued to sell the device for nine months while company officials engaged in discussions with the FDA. In 2008, the FDA allowed sales of the Gynecare Prolift to resume. J&J faced no sanctions or fines for selling the device for two years without FDA approval, nor for continuing to sell the product after the FDA ordered sales to halt.
J&J never applied for FDA approval of the Gynecare Prolift because the company independently determined that it was “substantially similar” to other FDA approved vaginal mesh devices. Unfortunately, “similar” vaginal mesh devices had already been recalled due to safety hazards.
The FDA has issued multiple warnings regarding the safety of vaginal mesh. The first warning was issued in 2008, in response to more than 1,000 adverse event reports. The second warning was issued in 2011, after the FDA received an additional 3,000 adverse event reports. They warned that serious complications were “not rare.”
Gynecare Prolift Side Effects
The side effects of the Gynecare Prolift include:
- Life-threatening infection, which can also cause more serious complications (scarring, nerve damage, etc.)
- Mesh erosion into the vaginal wall
- Pain, which may be chronic or interfere with sexual intercourse
- Severe scarring or disfigurement of the vagina
- Perforation of the bowel, intestines, bladder, blood vessels
- Severe bleeding
- Nerve damage
- Urinary problems
- Return of Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI)
- Psychological damage
Additional surgery is usually necessary when these complications occur. Surgery may be required to remove a defective Gynecare Prolift, repair injuries, or replace the device. Unfortunately, some complications cause permanent injury. For example, nerve damage or scarring can make all sexual intercourse painful, which can significantly decrease quality of life.
Gynecare Prolift Lawsuits
If you have suffered from Gynecare Prolift side effects, you may have a Gynecare Prolift lawsuit. If you decide to file a Gynecare Prolift lawsuit, you will join more than one thousand other women who are seeking justice for their transvaginal mesh injuries. You may be entitled to significant financial compensation for your pain, suffering, past and future medical expenses, lost income, decreased quality of life, and more.
Currently, the Multidistrict Litigation (MDL) against four manufacturers of transvaginal mesh is proceeding in federal court. In an MDL, each person’s case remains independent, but they are centralized in one federal court to improve efficiency, reduce costs, and eliminate the risk of having different rulings in different courts.
You may still have time to file a Gynecare Prolift lawsuit. For more information, contact The Clark Firm, LLP.
Do I have a Gynecare Prolift Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Gynecare Prolift Lawsuit review.