Transvaginal Mesh FAQ
Transvaginal mesh is a surgical mesh product that is used to treat conditions including stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Unfortunately, it is also a dangerous product and there have been thousands of lawsuits filed by women who have experienced serious and painful complications associated with the surgical mesh.
If you or a loved one has undergone a procedure with TVM and are experiencing complications, it is important to understand your legal rights. A Boston transvaginal mesh lawyer at the Law Offices of Jeffrey S. Glassman can evaluate your case and provide you with information on your claim, and you can also review some answers below to frequently asked questions about transvaginal mesh.
What is transvaginal mesh?
Transvaginal mesh is a surgical mesh product that is used to help reinforce the muscles in the pelvic region. It is used to treat pelvic organ prolapse or stress urinary incontinence. There are a number of manufacturers of transvaginal mesh products including Ethicon (a subsidiary of Johnson & Johnson), and C.R. Bard
Why are transvaginal mesh devices dangerous?
From 2005 to 2010, the FDA received more than 4,000 reports of injuries as a result of transvaginal mesh products. The FDA estimates that the failure rates of this surgical mesh product may be as high as 10 percent for patients using TVM as a treatment for SUI or POP.
What are some complications of transvaginal mesh products?
Transvaginal mesh products can cause a number of complications and side effects including recurrence of the POP or SUI; vaginal scarring or vaginal shrinkage; inflammation; infection; erosion of the mesh; perforation of the vagina or bladder; urinary problems; discomfort during sexual intercourse; bleeding and pain.
Will everyone experience complications?
Transvaginal mesh will not necessarily cause complications or problems in every patient. However, many thousands of patients have already begun to experience problems and many more patients will experience unexpected side effects and device failure.
How did transvaginal mesh products get approved if they are so dangerous?
There are special 501(K) clearance rules that allow medical devices to come to the market with minimal testing if they are substantially similar to devices and products already approved. The first transvaginal mesh product was given FDA clearance in 1996 based on its similarity to surgical mesh used for treating hernias. There were no human safety tests done before the product was released and the approval was based on a three-month study of the device using rats.
Have vaginal mesh products been recalled?
The FDA issued a 522 order, also called a post-market surveillance order, mandating that 33 manufacturers conduct in-depth studies as to the safety of their products. While the FDA has not instituted a full recall of all surgical mesh products, individual manufacturers have recalled their products and/or removed them from the market. This includes the first TVM product approved, the Boston Scientific ProteGen, which was recalled in 1999 three years after its launch. Ethicon, a Johnson & Johnson subsidiary, also stopped selling its Gynecare mesh products in 2012.
What should I do if I have a TVM implant?
If you are not experiencing complications, you do not need to take any action. However, you should undergo regular checkups annually to watch for signs of adverse reactions and you should be alert to the symptoms of problems including bleeding, persistent discharge and pain.
What should I do if I am experiencing complications?
If you are experiencing complications as a result of your transvaginal mesh device, you should contact an experienced attorney who can help you to pursue a claim for compensation against the manufacturer. Thousands of claims have already been filed and plaintiffs have successfully prevailed against TVM manufacturers, including one case in which an injured woman was awarded $2 million from C.R. Bard.
An experienced Boston transvaginal mesh lawyer at the Law Offices of Jeffrey S. Glassman can help with your case, so give us a call or contact us online today to schedule a free consultation.