Transvaginal mesh is a synthetic or biologic material permanently implanted in women to repair pelvic organ prolapse (POP) or to support the urethra as a treatment for stress urinary incontinence (SUI), conditions which arise when the vaginal wall and other supporting muscles have been weakened. This weakening often occurs as a consequence of pregnancy and childbirth, and may also arise from other factors, including aging.
The U.S. Food & Drug Administration (FDA) has determined that transvaginal mesh may cause complications such as the erosion of the product into surrounding areas of the pelvis and perforation of pelvic organs. As a result, the FDA has taken the following actions:
- As early as 2007, the FDA began investigating issues related to the use of vaginal mesh in gynecologic and urologic surgery. More than 1,000 women had reported complications from POP or SUI procedures in which transvaginal mesh failed.
- In October 2008, the agency notified transvaginal mesh manufacturers about reports of potential adverse complications stemming from the devices (more than 1000 reports from 2005 to 2007).
- By July 2011, the FDA had received 1,500 additional complaints from transvaginal mesh surgery patients, and on July 13, 2011, the agency issued a stronger warning to physicians and the public, advising patients to consider alternative treatments.
- In September 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that any surgical mesh used to treat pelvic organ prolapse (POP) be reclassified from a moderate-risk device (class II) to a high-risk device (class III), and also recommended that manufacturers be required to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
- On January 4, 2012, the FDA ordered Johnson & Johnson, Endo, C.R. Bard, Boston Scientific, and 30 other manufacturers of surgical mesh to conduct new studies on the safety and effectiveness of vaginal mesh when used to treat pelvic organ prolapse and stress urinary incontinence, and to monitor the rate at which adverse events were reported.
- On April 9, 2014, the FDA issued two proposed orders to address health risks associated with surgical mesh used for transvaginal repair of POP. This is the next step for the agency toward formalizing the 2011 recommendations from the FDA’s Obstetrics and Gynecology Devices Panel concerning class II to class III reclassification and requirement for manufacturers to submit PMAs.
Meanwhile, Johnson & Johnson’s Ethicon unit stopped selling its Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure and Gynecare Prosima Pelvic Floor Repair System Kit; C.R. Bard Inc. halted sales of its Avaulta Plus mesh product; and numerous product recalls have been issued by various mesh manufacturers. See our Manufacturers page for a more comprehensive list of manufacturers, their mesh products, recalls, and market withdrawals.
These actions emerged as thousands of lawsuits were been filed by women injured by transvaginal mesh implants. In several of the cases which have gone to trial, juries have awarded millions of dollars in damages. In other cases, manufacturers settled thousands of cases out of court in order to avoid the risk of going to trial and having juries award unpredictably large settlements. Still more cases are pending in federal class-action suits. See our Lawsuits page for information on the lawsuits that have been settled and those still pending, as well as details on what you need to do if you have been injured and believe you may have a claim.
The implantation of transvaginal mesh can be harmful to women’s health.Thousands of women are suffering from complications caused by this medical device; some have even died.
To learn more about transvaginal mesh, why it is used, and some of the consequences it has caused, click here.
If you or a loved one developed complications after surgery to repair POP or SUI in which transvaginal mesh was implanted, you may be entitled to compensation. Recovery may include past and future medical bills, lost wages, diminished quality of life, and pain and suffering. If you are the spouse of a victim, you may be able to recover damages due to loss of spousal consortium or, if your loved one died, compensation for the loss of her companionship.
To find out if you have a claim, please call Avram Blair & Associates P.C. at 919-729-5152?? or out our online contact form for a free consultation.