January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
On Friday, the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee concluded a two-day meeting to review the safety and effectiveness of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Since 2002, the FDA has cleared more than 100 mesh products for POP repair and 78 mesh devices for SUI treatment.
During this two-day hearing, Herbert Lerner, Acting Division Director at the FDA, testified that in 2010, professional societies expressed concern about adverse events associated with vaginal mesh for POP repair. The FDA reported during this hearing that erosion is unique to mesh procedures and is not experienced by patients who undergo a traditional repair. The FDA further explained that erosion into the vagina is the most common and consistently reported mesh-related complication following POP repair in the literature. The weighted average of mesh erosion in the literature ranged from 7.7% to 19%. In addition, the FDA reported to the panel that 54% of patients experienced urinary problems within 48 months after mesh placement (reported from 2 treatment groups and 65 total patients) while 19% of patients reported erosion within the first 36 months.
The FDA also presented evidence that of the 1503 adverse event reports they reviewed, 27.6% needed an additional surgical procedure, 12.1% required partial or complete mesh removal and 4.8% of patients required additional hospitalization.
The FDA recommended that the Advisory Committee panel order post market surveillance of the transvaginal mesh products currently on the market. They stated that the literature does not prove that surgical mesh is effective compared to the traditional repair and that the rate and severity of mesh-specific adverse events calls the safety of mesh products into question. Jill Brown, testifying for the FDA’s Office of Device Evaluation, explained that serious adverse events related to vaginal repair using surgical mesh is not a rare occurrence. She also found that little is known as to long term implications from surgical mesh placement.
The transvaginal surgical mesh manufacturers attempted to argue that mesh exposure is different than erosion, and that the FDA database where the public reports device problems is not a proper database for evaluation. The surgical mesh manufacturers reported that only 10.3% of patients experienced mesh exposure resulting in the following treatment: 11% no treatment; 21% topical estrogen; 11% in office procedure; and 56% partial surgical excision.
John Pedersen, Senior Vice President and President of Boston Scientific’s Urology and Women’s Health Division issued a statement after the conclusion of the two days of testimony. Mr. Pedersen stated that “Boston Scientific believes that mesh products are a valuable option for surgeons who treatment women with pelvic floor disorders and stress urinary incontinence.” He further explained how Boston Scientific “believe[s] the current 510(k) requirements for Class II devices are appropriate for surgical mesh devices intended to treat pelvic organ prolapse and stress urinary incontinence.” Regardless, he stated that Boston Scientific would continue to work with the FDA and other transvaginal surgical mesh manufacturers regarding the safety and efficacy of this device.
At the conclusion of this two-day hearing on transvaginal surgical mesh, the Advisory Committee panel did not take any formal votes. However, the panel did seem to suggest that additional data on surgical mesh used for the newer generations of the SUI repair mesh devices might be useful. In addition, they indicated that mesh devices for treatment of POP may be reclassified from Class II to Class III, which would place transvaginal mesh as a high risk device due to safety concerns. Once the panel takes a formal vote, the panel submits its recommendation to the FDA. The FDA does not have to follow the advice of its advisory panels, but it often does.