In early July, Boston Scientific announced in a press release on the Boston Scientific website that the company would be giving a grant of more than a million dollars to the Pelvic Floor Disorders Network (PFDN). The grant is for further research into the effectiveness and safety of the company’s transvaginal mesh products.
Our Dallas personal injury attorneys know that 33 manufacturers were ordered by the Food and Drug Administration (FDA) in 2013 to conduct additional studies on transvaginal mesh. The FDA made this demand because of increasing reports of complications caused by the surgical mesh products. Boston Scientific’s new grant is a part of the company’s efforts to comply with the FDA mandate.
Boston Scientific Funds Study on Transvaginal Mesh Products
The Pelvic Floor Disorders Network will be conducting a study called SUPeR. The purpose of the study is compare transvaginal mesh with an alternative treatment option in order to determine if there are treatment advantages to the use of the mesh product as compared with other solutions to pelvic organ prolapse.
There will be a total of 180 women involved in the study. The participants are women who do not wish to have any more children and the two treatment alternatives being compared will be the Boston Scientific Uphold® LITE Vaginal Support System and a traditional surgery that includes a hysterectomy but that does not require the use of a transvaginal mesh product.
The treatment outcomes of the different women will be compared in order to determine whether the women with the vaginal mesh support have a better outcome. Researchers will check in with the women in the study every six months for five years after their pelvic organ prolapse treatment, both to determine the effectiveness of the treatment at stopping recurrent pelvic organ prolapse and to determine whether complications developed. The ongoing follow-ups will assess whether the surgery was safe and how the patient’s quality of life is after undergoing the specific pelvic organ prolapse care.
The Pelvic Floor Disorders Network is funded by the National Institutes of Health and is independent from Boston Scientific so the outcome of the study should not be influenced by the grant from the medical device manufacturer. Boston Scientific has made the grant available to comply with FDA demands prompted by concerns that vaginal mesh products are not worth the risk they present to patients.
Unlike most traditional pelvic organ prolapse treatment methods, vaginal mesh has been linked to serious complications including pain during intercourse; erosion of the mesh and recurrent prolapse. If there are no significant advantages to the use of the mesh, then there would be no reason for patients to accept the risks of these side effects by using transvaginal mesh to treat their condition.
The outcome of the new PFDN study is expected to be available in 2017 with an additional follow-up review coming a year later. While patients will thus have to wait a long time for these study results, there is already ample evidence to indicate that mesh products are dangerous and that the risks simply aren’t worth it for patients.
If you’ve been harmed by transvaginal mesh products, contact the Carse Law Firm. Call 877-865-2580 or complete our online contact form for a free consultation.