A transvaginal mesh implant, also known as pelvic mesh, is a type of medical device that is used to treat two common medical conditions: Pelvic Organ Prolapse and Stress Urinary Incontinence. These conditions may occur following child birth and pregnancy.
More than 1000 reports of mesh complications with the transvaginal mesh implant referenced in the FDA notification raised concerns about the adequacy of training, and the ability to prevent complications. In February 2009, the FDA advised clinicians using a transvaginal mesh implant for pelvic organ prolapse and stress urinary incontinence that the clinicians should: (1) obtain specialized training, (2) be aware of adverse events associated with a transvaginal mesh implant, (3) inform patients of risks and treatment options, and (4) provide patients with the product labeling. Since this warning, thousands of women have brought product liability actions for injuries arising from the use of transvaginal mesh.
Joe Lyon is a highly rated Ohio medical device lawyer representing women throughout the United States who have been injured by a transvaginal mesh implant. If you have questions whether in injury was caused by a transvaginal mesh implant or the state of the national medical device litigation, please call for a free and confidential consultation.
The complications and side effects possibly related to defects in the pelvic mesh. The side effects include:
The Lyon Firm cannot offer medical advice, but the medical literature has recommended the following:
The guidelines further stated that the following factors may increase the adverse events:
Although the products are widely used, there is little science comparing the pelvic mesh procedures to traditional surgical methods.
Altman conducted a randomized, controlled trial comparing the use of a standardized trocar guided mesh kit with the traditional anterior colporrhaphy surgery. The trial was limited to 389 women and the composite was based on both a subjective and objective outcome. While there was a lower rate of recurrence of pelvic organ prolapse after one year, there was a higher rate of adverse events, including bladder perforations, pelvic hemorrhage and mesh related complications. “[The] results highlight the need for careful evaluation of surgical innovations, which are often widely adopted in the absence of data from clinical trials.”
In light of the ongoing litigation in West Virginia and New Jersey, as well as the ongoing FDA investigation, Johnson & Johnson informed both the State and Federal Courts yesterday by way of formal letter, that it intends to “discontinue or revise, as appropriate, all marketing materials” and to stop worldwide sales of the following devices:
In January, the FDA ordered that J&J and 30 other makers of vaginal mesh implants implement studies to assess organ damage and other health complications alleged to be related to the products. The FDA further reported in March that The Gynecare Prolift has been sold for three years without proper regulatory approval.1
If you or a loved one suffered an injury due to a faulty transvaginal mesh implant and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions