The Gynecare Prolift Pelvic Floor Repair System was designed to help restore organ support for patients with pelvic organ prolapse (POP). A type of surgical mesh, it’s placed inside the pelvis through the vagina and acts as a sort of sling to keep pelvic organs in place.
Thousands of adverse event reports to the Food and Drug Administration (FDA), however, have brought to light the serious complications that can result from surgery with vaginal mesh. A recent Gynecare mesh FDA warning and subsequent Gynecare mesh FDA hearing illuminated the seriousness of this issue, and have led some to speculate on the possibility of a Gynecare mesh recall.
Why a Possible Gynecare Prolift Recall?
Many women 50 years and older experience POP, a condition in which the pelvic muscles and tissues become weakened and stretched due to childbirth, menopause, or surgeries. These muscles are then no longer able to support pelvic organs like the bladder, urethra, and bladder. One or more of these organs may then fall or drop forward into the vaginal wall.
Severe forms of POP may be treated with surgery, which may involve Gynecare Prolift. Manufactured by Ethicon, a subsidiary of Johnson & Johnson, Gynecare Prolift and other similar vaginal meshes were hailed as an improved solution to traditional non-mesh surgery because they reduce the risk of recurrence. Unfortunately, they also cause more post-treatment Gynecare mesh complications.
Gynecare Mesh FDA Warning
In 2008, the FDA warned about possible complications with vaginal mesh surgeries, but noted that these complications were rare. Then, between 2008 and 2010, the agency received five times as many reports of vaginal mesh problems as they had between 2005 and 2007. At the same time, new studies emerged highlighting the risks of complications, including mesh erosion into the vagina or other organs, scar tissue formation, infections, pelvic pain, urinary incontinence, and recurrence of prolapse.
In July 2011, the FDA issued an updated Gynecare mesh FDA warning stating that complications with vaginal mesh are not rare, and that it is unclear if POP repair with products like Gynecare Prolift is better than traditional non-mesh repair. The agency warned physicians to be aware of the risks, and to tell their patients that some of the complications may not be reparable even with additional surgeries.
Gynecare Mesh FDA Hearing
Following the updated warning, the FDA convened a subcommittee meeting to further evaluate the safety issues with products like Gynecare Prolift. As a result, the Obstetrics & Gynecology Devices Panel agreed that the safety of these devices has not been established, and that further clinical studies are needed to better explain the risks and benefits.
Critics Call for Gynecare Mesh Recall
Some concerned organizations and healthcare professionals have suggested that a Gynecare mesh recall may be the only way to ensure the safety of women going through POP surgery. Gynecare mesh lawyers feel the Gynecare Prolift did not meet reasonable safety standards, and that the company did not adequately warn of the potential risks. So far, however, no Gynecare mesh recall has taken place.
A Gynecare Mesh Lawyer May be Able to Help
If you or a loved one has experienced an injury as a result of Gynecare Prolift mesh, you may be eligible for compensation in a Gynecare mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.
