After receiving thousands of reports of complications related to transvaginal mesh, the Food and Drug Administration (FDA) has issued warnings related to the use of this mesh to treat two common conditions in women: pelvic organ prolapse and stress urinary incontinence. In spite of these warnings, hundreds of thousands of women continue to receive transvaginal mesh implants, often suffering serious complications as a result. A vaginal mesh lawsuit is being prepared to help these women recover damages. If you have experienced any vaginal mesh complications, contact McIntyre Law today to discuss your options with an experienced attorney.
Urogynecologic surgical mesh, also known as transvaginal mesh or simply vaginal mesh, is an implant made from absorbable or non-absorbable synthetic material or from biologic material that will be absorbed by the surrounding tissue. It is implanted transvaginally to treat urogynecologic conditions, most commonly pelvic organ prolapse and stress urinary incontinence. When used as a treatment for pelvic prolapse, its purpose is to reinforce the vaginal wall. For stress urinary incontinence, it acts as a support for the urethra or neck of the bladder.
Many women have experienced vaginal mesh complications during treatment of pelvic organ prolapse and stress urinary incontinence. Common complications can include vaginal tissue erosion, urinary problems, infection, pain, and a recurrence of the initial condition. Other mesh complications include, but are not limited to bleeding, neuromuscular problems, pain during sexual intercourse, vaginal shrinkage or scarring, and emotional issues.
Despite thousands of reports of vaginal mesh complications and the FDA warning, there is currently no transvaginal mesh recall in effect.
In October of 2008, the FDA issued its original warning about complications related to the implantation of transvaginal mesh. This warning was updated and reissued in July 2011, with two major revelations:
Several companies manufacture transvaginal mesh implants, including but not limited to the ones listed below. If you’re not sure what brand of mesh you received, or if it’s a brand associated with vaginal mesh complications, check with your doctor.
In 1996, the FDA approved transvaginal mesh for the treatment of stress urinary incontinence. The mesh was approved to treat pelvic organ prolapse in 2002.
In October 2008, the FDA issued a public health notification to warn of serious complications related to the implantation of transvaginal mesh to treat pelvic prolapse and stress urinary incontinence. During the three years prior to that warning, the FDA had received more than 1,000 reports of vaginal mesh complications based on products made by nine manufacturers.
The FDA reports that in 2010, approximately 300,000 women had transvaginal surgery to correct pelvic prolapse, while nearly 260,000 had transvaginal surgery for stress urinary incontinence. A large percentage of these surgeries used mesh to treat both conditions. That’s more than half a million women in one year. We conclude that over the past 15 years, millions of women have had these devices implanted and are now at risk for the side effects associated with transvaginal mesh.
Some mesh complications are related to, and occurred during, the surgical procedures used to implant the transvaginal mesh. These include vaginal scarring; and perforation of the bladder, bowel, or blood vessels. Each of these can lead to infection, pain, and a significant decrease in the quality of life of the patient.
If you have had transvaginal mesh implanted, and have experienced complications such as bleeding, pain, a recurrence of the original condition, pain during intercourse, or any other unusual symptoms, you should consult your doctor immediately to determine whether the complications were caused by the mesh. If complications are related to the implant, you can be compensated when you participate in a vaginal mesh lawsuit.
This condition is different from generalized incontinence in that stress urinary incontinence, also called stress incontinence or SUI, is brought about by an activity like exercise, or by a sudden stress imposed on the body by an event such as sneezing, coughing, laughing, or even heavy lifting. In addition to being inconvenient, it can be a source of tremendous embarrassment for the women who suffer from it.
Two muscles are related to the control of urine flow in the body: the sphincter and the detrusor. The sphincter is a circular muscle that surrounds the urethra. Squeezing this muscle prevents urine from being expelled from the body, or leaking out when a sudden stressful bodily event occurs. The detrusor muscle is located in the bladder wall, and usually remains in a relaxed state, allowing the bladder to expand as it fills.
Stress urinary incontinence occurs when one or both of these muscles is weakened, causing the body to lose control of urine flow, which can result in urine being involuntarily expelled from the body, especially when you cough, sneeze, or laugh. It is the most common type of urinary incontinence suffered by women, and is often treated with surgery, including the implantation of transvaginal mesh to support the urethra and the bladder.
Other than simply being female, other factors increase the risk of developing stress urinary incontinence. These factors include, but are not limited to:
If one or more of these factors applies to you, then you are at greater risk of developing stress urinary incontinence.
To understand this condition, also known as pelvic organ prolapse or POP, it is necessary to first understand that “prolapse” means to fall down or slip out of place. When the pelvic floor weakens, and is no longer able to support the organs housed in the pelvic area, those organs could slip from their normal positions, resulting in pelvic organ prolapse. This can occur with one or more organs that are in this area, including the uterus, vagina, cervix, urethra, rectum, and most commonly, the bladder.
It’s quite common for the muscles that make up the pelvic floor to become weakened as a result of childbirth. Other causes include, but are not limited to frequent constipation; connective tissue disorder; genetic predisposition; obesity; or, simply, age. Many women may have pelvic prolapse and not even realize it because the symptoms are so mild. When the symptoms do present in a more aggressive manner, they can include pain, discomfort, urinary incontinence, sexual difficulties, and most importantly, the bulging of tissues or organs beyond the vaginal opening.
While pelvic prolapse can be treated without surgery, once it progresses to the point of chronic pain, incontinence, or bulging of the internal tissues and organs outside the body, surgery is usually recommended. A surgeon will restore any prolapsed organs to their original positions, and may reinforce the pelvic and vaginal walls with transvaginal mesh in an effort to prevent pelvic organ prolapse from recurring.
If you have a transvaginal mesh implant, you could be eligible to participate in a vaginal mesh lawsuit. We work with clients across the country on mesh lawsuits. Contact one of our experienced defective medical device attorneys immediately by completing our contact us form for a free consultation. Or, call us toll free at (877) 917-5250.
If you don’t have a vaginal mesh implant, you are not eligible to participate in a vaginal mesh lawsuit, but you should know that several other defective medical devices have been recalled. Please see our other information pages to find out if you are affected by any other medical device recall: