Transvaginal mesh and its complications made headlines this week as a jury reached a $3.35 million compensatory damages verdict in a New Jersey Court, with punitive damages to follow. This bold action ignites concern and questions for thousands of other women implanted with the same device.
What is transvaginal mesh?
Transvaginal mesh is a medical device used to repair weakened or stretched tissue caused by conditions such as pelvic organ prolapse (POP) and stress urinary incontinence(SUI). The mesh is made from relatively cheap synthetic materials such as polyester and polypropylene (developed from petroleum). Surgical mesh is inserted through the vagina during pelvic surgery. 79,500 of these profitable devices were sold in 2010 at $2,000 apiece in the United States. In one of our cases, the Alabama surgeon performing the procedure told a patient he implanted 3-5 devices a week.
What conditions are transvaginal mesh used to treat?
- Pelvic organ prolapse (POP)
- Stress Urinary Incontinence (SUI)
What are the complications of transvaginal mesh?
- Erosion of Tissue
- Bladder Injury
- Bowel Injury
- Pain During Sexual Intercourse
According to an article in the July issue of Nursing 2009, Volume 39, Issue 7, "a patient, 67, had a transvaginal repair with synthetic mesh for pelvic organ prolapse. Four weeks later, she reported spotting, discomfort, and vaginal irritation. The surgeon found that the surgical mesh had eroded into her vagina and prescribed estrogen cream for a month, but it wasn't effective. The patient needed more surgery for resection of the exposed mesh and closure of eroded tissue." The injuries reported in this journal article are similar to those we have heard from many women while investigating these claims.
Has transvaginal mesh been tested and studied?
Available data on transvaginal mesh is limited, as testing of the device prior to placement on the market is inadequate. As a result, venerable organizations, such as the American Congress of Obstetricians and Gynecologists (ACOG), recommend that clinicians be vigilant for possible adverse events from mesh.
A review by the Society of Obstetricians and Gynaecologists of Canada (SOGC) found that 5-19% of the surgeries using mesh had erosion and 18% of women developed pelvic muscle dysfunction and pain. Similarly, a recent study by Danderyd Hospital in Sweden concluded that surgeries using mesh resulted in higher rates of surgical complications and postoperative adverse events than the traditional colporrhaphy surgery.
Are there government warnings for the use of transvaginal mesh?
The FDA alerted the public in 2008 to the complications associated with transvaginal mesh and followed with an update in 2011 reporting that the complications were not rare.
Has transvaginal mesh been recalled?
Johnson & Johnson recalled and removed vaginal mesh products associated with these complications from the market in June 2012.
Are the vaginal mesh manufacturers facing lawsuits?
Women across the country are taking action against the manufacturers of these surgical mesh products in an effort to battle the staggering medical costs, lost wages and other quality of life issues that have taken a beating due to this faulty product. The recent lawsuit involving $3.35 million in compensatory damages follows a a similar mesh lawsuit in California resulting in a jury decision of $5.5 million.
What companies manufacture transvaginal mesh?
- Johnson & Johnson/Ethicon
- American Medical Systems (AMS)
- Boston Scientific Corporation
- C.R. Bard
What to do if you have had complications with vaginal mesh:
I always stress to my clients that they should get the best medical care as quickly as possible. If you choose to seek legal counsel, look for a lawyer who has actual trial experience helping people who have suffered severe injuries and disabilities. Too many television lawyers simply push paper. The women injured by these products deserve an attorney with the knowledge, skill and desire to pursue their case to the courtroom if needed. I would be happy to answer any of your questions at (256) 650-5500.