The Food and Drug Administration (FDA) Commissioner Scott Gottlieb first announced the agency would meet on surgical mesh safety and effectiveness of transvaginal pelvic organ prolapse repair in a statement November 20, 2018. The FDA reported approximately 2, 874 adverse events from January 1, 2008 until December 31, 2010. The most common adverse events for pelvic organ prolapse included erosion (35.1%), pain (31.4%), infection (16.8%), bleeding (8.2%) and dyspareunia (7.2%).
“The advisory committee meeting will seek expert opinion regarding the available evidence of the benefits and risks of mesh for transvaginal POP repair and provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions,” Gottlieb said in November.
On October 20, 2008, the FDA warned of serious complications associated with transvaginal placement of surgical mesh of pelvic organ prolapse and stress urinary incontinence. Specifically, the FDA received over 1,000 reports from nine mesh manufacturers of serious complications including erosion through vaginal epithelium, infection and pain.
On July 13, 2011, the FDA issued a Safety Communication to physicians and patients stating that vaginal mesh had been associated with complications including erosion through the vaginal epithelium, infections, pain, urinary problems and bladder perforation. The FDA ordered 34 manufacturers to conduct postmarket surveillance studies, resulting in the companies halting marketing of their products. Manufacturers included: American Medical Systems (AMS); C.R. Bard, Ethicon (Johnson & Johnson subsidiary); Boston Scientific; Coloplast; and Mentor.
For instance, in June 2012, Johnson & Johnson’s Ethicon division stopped selling four types of their mesh implants, GynecareTVTSecur™, System, GynecareProsima™ Pelvic Floor Repair System, GynecareProlift™ Pelvic Floor Repair System, and GynecareProlift+M™ Pelvic Floor Repair System, used to treat stress urinary incontinence. The company said that it was removing the products “in light of changing market dynamics and is not related to safety or efficacy.” However, the timing was coincidental, given the FDA’s demand that the manufacturers test these products and monitor adverse event reports. Also, in July 2012, C.R. Bard stopped selling the AvaultaPlus Biosynthetic Support System. This was after a $5.5 million verdict was obtained for a Plaintiff in California against C.R. Bard based on the AvaultaPlus Biosynthetic Support System
The FDA found little evidence to support the use of mesh in pelvic organ prolapse and reclassified the mesh as a “high-risk” product. Approximately 300,000 women received vaginal mesh implants in the United States in 2010. The FDA has asked mesh manufacturers including Ethicon (J&J subsidiary), C.R. Bard and AMS to conduct three years of trials on the safety and effectiveness of their products.
On February 12, 2019, the FDA’s Obstetrics and Gynecology Devices Panel of its Medical Devices Advisory Committee will assess the effectiveness, safety, risks and benefits of mesh placed transvaginally in the anterior vaginal compartment.