In 2011, the FDA warned surgeons and patients that using transvaginal mesh to repair pelvic organ prolapse puts patients at greater risk than other surgical treatment options.
The sad fact is that transvaginal mesh was never tested for vaginal repairs. Instead, transvaginal mesh, which has been used to successfully repair hernias for years, was put on the FDA’s fast-track approval system, called the 510(k), which does not require testing prior to market release.
Only after reviewing published scientific research from 1996 to 2011 did the FDA discover that transvaginal mesh repairs of pelvic prolapse (vaginal repairs) often failed to fix the symptoms of prolapse or improve the patient’s quality of life as compared to non-mesh repair treatments. This has led to numerous transvaginal mesh lawsuits.
If you or someone you know has had organ prolapse or urinary incontinence surgery and later required revision surgery, please call us immediately at 1.866.472.9108 or contact us here to learn more about the transvaginal mesh lawsuit.
As noted by the FDA, the common complications of the transvaginal mesh recall device are serious and include infection, pain, recurrence of prolapse, urinary problems, incontinence and erosion through the vaginal epithelium. The FDA also discovered that transvaginal mesh often shrinks once inside the patient, causing vaginal tightening and pain. Additionally, there have been many reported cases of bowel, bladder and even blood vessel perforation during the insertion of transvaginal mesh. There have also been reports of vaginal scarring, discomfort and pain including dyspareunia, leading to a significant decrease in patient quality of life due to transvaginal mesh erosion.
Transvaginal mesh litigation began as a response to the physical and emotional pain suffered by transvaginal mesh patients. In particular, transvaginal mesh litigation and transvaginal mesh lawsuits have helped to pinpoint the unnecessary risks that transvaginal mesh patients encountered.
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Transvaginal mesh litigation has spotlighted the many FDA warnings for transvaginal mesh use in surgery. One such warning occurred in 2008, when the FDA made a public health notification listing the serious complications specific to transvaginal mesh revision surgery. In another warning in 2011, the FDA warned surgeons and patients that using transvaginal mesh to repair pelvic organ prolapse puts patients at greater risk than other surgical treatment options. Another FDA report, dated July 2011, disclosed that transvaginal mesh prolapse repairs between 2008 and 2010 caused thousands of injuries and seven deaths. The same FDA warning also stated that there is no evidence that transvaginal mesh use ever improves prolapse surgery outcomes.
Why did some companies continue to manufacture and sell transvaginal mesh devices when there was substantial proof of risks associated with transvaginal mesh use? Why did some companies continue to manufacture and sell transvaginal mesh when other companies paid heed to the problems and pulled their own devices from the market?
Transvaginal mesh lawyers are working to uncover the answers.
Currently, transvaginal mesh has not been completely recalled from the market, although the FDA’s Obstetrics and Gynecology Devices Advisory Committee did assist in reclassifying the transvaginal mesh device as Class III, meaning all future devices must undergo premarket approval to ensure safety and effectiveness. In January 2012, the FDA also required all transvaginal mesh manufacturers to perform three-year studies on their products to determine the device’s side effects and the effects on the patient’s overall quality of life.
Pelvic organ prolapse (POP) is a condition that occurs when the tissue that keeps the pelvic organs in place become stretched or weakened. Between thirty to fifty percent of women may experience pelvic organ prolapse in their lifetime, with two percent of women developing symptoms. The symptoms of pelvic organ prolapse involve a bulging (or prolapse) of organs into the vagina, sometimes even past the vaginal opening. Organs that can prolapse include the uterus, the rectum, the bladder, the bowel and the top of the vagina (vaginal apex), ofter after a hysterectomy. Sometimes referred to as pelvic floor disorder, more than one pelvic organ can prolapse at the same time.
Stress Urinary Incontinence (SUI) involves a leakage of urine in moments of physical activity such as exercise or coughing, sneezing or laughing.
Both pelvic organ prolapse and stress urinary incontinence tend to occur in women after childbirth, hysterectomy or menopause.
First used in the 1990s for this treatment, transvaginal mesh was thought to permanently fix these pelvic organ conditions. However, serious problems associated with the mesh have led to multiple transvaginal mesh lawsuits.
Unfortunately, the most common problem associated with transvaginal mesh is also the most dangerous: transvaginal mesh erosion. Also known as transvaginal mesh extrusion, transvaginal mesh erosion occurs when the rough edges of the synthetic mesh cut through the vaginal lining and the nearby organs.
Transvaginal mesh erosion causes organ perforation, bleeding, infection, pain while sitting, walking, or during intercourse and urinary problems. In addition, the FDA warns that there are also reports of recurrent prolapse, neuromuscular problems, vaginal scarring and emotional problems as a result of the transvaginal mesh recall treatment. Less severe side effects of the transvaginal mesh recall treatment include urinary inconvenience and constipation.
There were over 75,000 transvaginal mesh surgeries performed in 2010 and at least ten percent of these resulted in failure. Women who have experienced problems with the transvaginal mesh often turn to urogynecologists, who are specialists in the area, to help reverse the surgery. However, reversing the damage done by the transvaginal mesh is not always possible. Some women undergo multiple operations to remove pieces of the transvaginal mesh yet these revision surgeries do not always relieve the complications. Removing transvaginal mesh is particularly difficult as tissue grows in and around the mesh and multiple surgeries are often needed. Surgical removal of the transvaginal mesh is painful, costly and dangerous, involving both lengthy recovery periods and a high risk for further problems.
In addition to revision surgeries, some women must also undergo restorative treatments for transvaginal mesh issues including IV therapy, blood transfusions, and drainage of hematomas and abscesses.
Increasingly, medical experts report that complications with vaginal mesh are inevitable – meaning, if complications do not occur right away, they likely will occur within a few years of transvaginal mesh placement.
To learn more about the transvaginal mesh lawsuit, call us at 1.866.472.9108 today or contact us here.
The majority of people involved in the transvaginal mesh lawsuit blame mesh manufacturers, not the individual surgeons who implanted their mesh device. This is because surgeons typically relied upon the information given to them by the mesh manufacturer and the FDA. And, unfortunately, while the FDA issued several warnings regarding transvaginal mesh, the warnings were insufficient given the high number of severe transvaginal mesh side effects and other problems.
If you are suffering from complications due to transvaginal mesh revision surgery, you may be able to file a transvaginal mesh lawsuit.
A woman who participates in a transvaginal mesh lawsuit may be able to receive financial help to cover medical expenses, lost wages and related expenses as well as to help compensate for future medical care. Thousands of woman have already joined the transvaginal mesh lawsuit.
The transvaginal mesh lawsuit was consolidated into multi-district litigation because of the many lawsuits that were filed regarding similar issues with transvaginal mesh – even though transvaginal mesh is manufactured by a number of different companies. The transvaginal mesh lawsuit involves five companies: American Medical Systems, Boston Scientific Corp, C.R. Bard, Johnson & Johnson and Coloplast. Each of these companies’ various models, allege the transvaginal mesh lawsuit, share similar design flaws and associated risks.
To participate in the transvaginal mesh lawsuit, give us a call at 1.866.472.9108 today. Our transvaginal mesh lawyers will offer you a free and confidential consultation to determine if you qualify for a transvaginal mesh lawsuit.