On July 13, 2011, the FDA released an updated safety communication on vaginal mesh, which is a surgical netting material used to treat conditions like pelvic organ prolapse and stress urinary incontinence. The warning alerted physicians to complications with vaginal mesh repair, and stated that these complications are not rare, and may lead to lasting damage.
There are several brands of vaginal mesh currently on the market. One of the top manufacturers is American Medical Systems (AMS), which makes vaginal mesh and bladder sling products including Apogee, MiniArc, Monarc, Perigee, Elevate, and SPARC.
American Medical Systems Mesh
American Medical Systems mesh is used to help provide support and strength to pelvic muscles and tissues that have become weakened over time. Because of childbirth, surgeries, menopause, or weight gain, these muscles may lose their ability to support pelvic organs like the bladder, urethra, and bowel, and allow one or more to fall or drop out of position (called pelvic organ prolapse). The organ then typically presses against the vaginal wall, or may even fall into the opening of the vagina, potentially causing symptoms like urinary incontinence, pain, pressure, and pain during sex.
To repair AMS prolapse, surgeons use AMS mesh to help shore up failing muscles and tissues and keep pelvic organs in place. According to the AMS mesh website, Apogee “is designed to restore patient anatomy and normal function,” while Perigee is made specifically to treat bladder prolapse (cystocele). Perigee, according to the site, “allows a surgeon to position a supportive mesh that is designed to provide support where the bladder herniates into the vaginal wall.”
AMS MiniArc is a type of mesh called a “bladder sling” that helps correct urinary incontinence. The mesh comes in a narrow strip to support the urethra and prevent accidental urine leakage. The AMS Monarc is a similar product, made to cradle the urethra, as is the SPARC sling system. The difference between these last three is mostly the surgical approach used to install them. Finally, the AMS Elevate (Anterior and Apical) is a surgical mesh meant to treat cystocele and prolapse.
AMS Mesh Complications
Following over 3,000 reports of problems with vaginal mesh, the FDA issued its warning in July 2011. According to the agency, AMS mesh complications may include erosion of the mesh into the vagina, infections, incontinence, pelvic pain, recurrence of pelvic organ prolapse, perforation of the bladder, and more. Many of these AMS mesh complications cause lasting pain and discomfort for women, severely limiting quality of life.
The FDA recommended that physicians be aware of the risks, be vigilant for AMS complications like erosion and infection, and inform patients that some complications may require additional surgery that may or may not correct the complication.
AMS Mesh Lawsuits
Since the FDA warning, more and more women have come forward to file an AMS lawsuit. American Medical Systems was recently named along with Boston Scientific Corp. (another vaginal mesh manufacturer) in a lawsuit alleging that the companies sold vaginal mesh products that were defective and caused severe injuries in women.
An AMS Mesh Lawyer May be Able to Help
If you or a loved one has experienced an injury as a result of AMS mesh, you may be eligible for compensation in an AMS mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.