Boston Scientific Announces New Transvaginal Mesh Study

Vaginal mesh manufacturer Boston Scientific has announced a partnership with the Pelvic Floor Disorders Network to study the effectiveness of vaginal mesh in treating pelvic organ prolapse (POP). The company will invest more than $1 million in the SUPeR study to determine whether these devices work better than traditional surgical procedures at keeping the uncomfortable symptoms of POP at bay. The study comes at a time when thousands of reports concerning transvaginal mesh complications have hit the FDA and courthouses across the country.

Announcement follows FDA surgical mesh warning

The announcement of the study follows an FDA safety communication issued in 2011 that stated there was no significant benefit in treating women diagnosed with POP with vaginal mesh products rather than traditional surgical procedures. That same safety announcement also claimed that serious transvaginal mesh complications are not rare, and recommended health care providers and patients carefully weigh the risks and potential benefits before choosing a pelvic mesh device to treat POP.

Shortly after releasing that safety announcement, the FDA also sent letters to manufacturers of vaginal mesh devices, including Boston Scientific. The letter ordered the companies to conduct additional studies to evaluate the safety of the devices. Originally, these devices were approved by the FDA under the agency’s controversial 510(k) program, which allows for approval of devices without pre-market studies if the manufacturer can show the new device is similar to another product already on the market.

New study to examine transvaginal mesh complications

Researchers for the new study plan to enroll 180 women seeking treatment for uterine prolapse. The women, who do not plan to have any more children, will be randomly treated with either the Boston Scientific Uphold LITE Vaginal Support System or a traditional vaginal hysterectomy. Researchers will then follow the women for five years through six-month evaluations to determine the success and safety of both the devices and surgery. Data from the study is expected to be compiled by 2017 and final study results should be released the following year.

“The data from this study will give physicians reliable evidence from a randomized trial on surgical treatment for women with uterine prolapse,” Charles Nager, M.D., director of UC San Diego School of Medicine’s Urogynecology and Reconstructive Pelvic Surgery Division, stated in a press release on the Boston Scientific website.

Vaginal mesh lawsuits alleging serious injury continue to mount

The first vaginal mesh devices were approved to treat stress urinary incontinence in 1996. In 2002, approval was extended to allow vaginal mesh to be used as treatment for pelvic organ prolapse as well. Unfortunately, many women have reported serious side effects from their mesh devices since that time, including mesh erosion and extrusion, pain and recurring infections. Some women have undergone vaginal mesh revision surgery to address the complications, but the subsequent procedures are not always effective in eliminating painful symptoms.

More than 20,000 women have filed lawsuits against mesh manufacturers like Johnson & Johnson, C.R. Bard, American Medical Systems and Boston Scientific. Federal transvaginal mesh lawsuits against Boston Scientific that have been coordinated into District Court in West Virginia now exceed 4,500.