In January of 2012 the Food and Drug Administration (FDA) ordered 33 manufacturers to conduct post-marketing studies on the safety of transvaginal mesh products. The FDA imposed this requirement because it had become apparent that side effects and complications due to transvaginal mesh products were very common.
Now, Boston Scientific, one of the major manufacturers of transvaginal mesh products, will be conducting further studies. On July 3, 2013, Boston Scientific announced in a press release that a grant of more than $1 million would be given to the Pelvic Floor Disorders Network (PFDN) for a new clinical trial to evaluate the treatment outcomes of two different surgical options for women suffering from a specific form of pelvic organ prolapse.
Our Boston transvaginal mesh lawyers know that most studies have shown that transvaginal mesh provides minimal or no benefits over other treatment methods and creates significant complications. This further study will focus more in depth on the differing treatment outcomes in order to provide more information on whether vaginal mesh products are worth the risk.
New Study on Pelvic Mesh and Treatment Methods
According to the Boston Scientific press release, the new clinical trial is called SUPeR. The study will involve 180 women who are considering surgery for uterine prolapse and who do not intend to have any more children. The children will be randomly assigned to one of two different treatment methods: a uterine-preserving transvaginal mesh repair that makes use of the Boston Scientific Uphold® LITE Vaginal support system or a traditional surgery that does not use a mesh product and that instead includes a vaginal hysterectomy.
The study will involve a randomized trial to determine which of the patients has the better outcome in order to evaluate each of the differing treatment methods. The patients will be evaluated by researchers every six months for as long as five years in order to assess the success of the surgery; to determine how safe the patients are; to assess the cost-effectiveness of the surgery; and to get an idea of the quality of life that each patient is enjoying following the treatment.
The initial data from the clinical trial is expected to become available in 2017 and there will be a follow-up a year later. The study will be conducted by the Pelvic Floor Disorders Network (PFDN), which is funded by the National Institutes of health and which has eight different medical centers located throughout the United States.
Determining the Effectiveness of Vaginal Mesh Products
Different types of pelvic organ prolapse have differing treatment methods and not all women wish to undergo a hysterectomy as a method of treating their condition. Still, vaginal mesh is a dangerous product and many women have experienced serious complications because of the vaginal mesh that was used in treatment procedures.
Those who use vaginal mesh products face significant risks including a danger of mesh erosion, recurrent prolapse and significant pain during intercourse. Hopefully those women who are involved in this clinical trial will not experience unexpected and dangerous side effects due to the Boston Scientific transvaginal mesh.