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, suffering serious mesh complications as a result. A vaginal mesh lawsuit is being prepared to help these women recover damages.
We are now accepting vaginal mesh lawsuit cases across the country in all the following states:
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
Vaginal Mesh Complications
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 complications related to vaginal mesh produced 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, and a large percentage of these surgeries used mesh to treat both conditions. That’s more than half a million women in one year. It can then be concluded that over the past 15 years, millions of women have had these devices implanted, and are now at risk to suffer the side effects associated with transvaginal mesh.
Numerous complications have been linked to transvaginal mesh, the most common including infection, urinary problems, pain, vaginal tissue erosion, and a recurrence of the initial condition (pelvic prolapse or stress urinary incontinence).
Other mesh complications include, but are not limited to bleeding, neuromuscular problems, pain during sexual intercourse, vaginal shrinkage or scarring, and emotional issues.
Some mesh complications are related to, and occurred during the surgical procedures used to implant the transvaginal mesh, and include vaginal scarring, and perforation of the bladder, bowel, or blood vessels, all of which 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 out-of-the-ordinary symptoms, you should consult your doctor immediately to determine whether the complications were caused by the mesh.
What Is Vaginal Mesh?
Urogynecologic surgical mesh, also known as transvaginal mesh or simply vaginal mesh, is an implant made from either synthetic material that can be absorbable or non-absorbable by the body, or of absorbable biologic material. 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.
What Is Stress Urinary Incontinence?
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 lifting something heavy. In addition to causing inconvenience, 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 which 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, including, but not limited to:
- Pelvic prolapse
- Injury to the urethra, or the surrounding area
- Pelvic surgery
- Vaginal childbirths
- Multiple pregnancies
- Chronic cough (as related to asthma or chronic bronchitis)
If one or more of these factors applies to you, then you are at greater risk of developing stress urinary incontinence.
What Is Pelvic Prolapse?
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 it no longer able to support the organs housed in the pelvic area, those organs may slip from their normal positions, resulting in pelvic organ prolapse. This can occur with one or more organs that reside 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 seriously, 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.
Transvaginal Mesh and FDA Warnings
The FDA issues its original warning about serious complications related to the implantation of transvaginal mesh in October 2008. This warning was updated and reissued in July 2011, with two major revelations:
- Serious complications related to mesh repair of pelvic prolapse are not rare
- There is no evidence that treatment of pelvic organ prolapse with mesh is more effective than treatment without mesh
Vaginal Mesh Recall
Despite the thousands of reports of mesh complications, and the warnings issued by the FDA, there is currently no transvaginal mesh recall in effect.
Vaginal Mesh Brands
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 mesh complications, check with your doctor.
- Johnson & Johnson
- Boston Scientific
- C. R. Bard
- American Medical Systems (AMS)
Vaginal Mesh Complications: What To Do
If you have a transvaginal mesh implant, you may be eligible to participate in a vaginal mesh lawsuit. We work with clients across the country for mesh lawsuits. Contact one of our experienced defective medical device attorneys immediately for a free consultation by filling out our contact us form or by calling us toll free at (877) 917-5250.
What If I Don’t Have a Transvaginal Mesh Implant?
If you don’t have a vaginal mesh implant, 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: