Washington, DCFrom 2011, the FDA has warned health professionals and the public that transvaginal mesh was associated with serious complications that were not rare, and recommended the mesh be bumped up from moderate to high risk. Almost five years later, the agency has reclassified mesh products designed and marketed for transvaginal treatment of POP to Class III “High Risk Devices,” which means more stringent regulatory requirements for the manufacturers.
Transvaginal mesh time frame: 2011-2016
2011
July: The FDA states that complications caused by transvaginal mesh devices are not rare, citing a dramatic increase in the number of adverse events reported between 2008 and 2010. (In 2008, the agency said in a public health notification that "Although rare, these complications [with TVM to treat POP and SUI] can have serious consequences.”) Here is the July 2011 FDA safety alert.
September: The FDA starts an advisory panel of pelvic surgeons to study and discuss transvaginal mesh products and recommend that the vaginal mesh be reclassified from a Class II device, requiring more tests. The FDA Advisory Obstetrics-Gynecology Devices Panel suggests that TVM implants be reclassified from moderate risk to high risk (Class III), which would mean that manufacturers would have to conduct studies based on human testing.
2012
The FDA orders 33 transvaginal mesh manufacturers to conduct 3-year post-market surveillance studies (“522 studies”) on the devices, to help the agency develop a better picture of the devices’ safety and effectiveness, focusing on stress urinary incontinence (SUI).
Mesh manufacturers face more than 650 lawsuits claiming mesh injuries. Lawsuits are filed against Johnson & Johnson, American Medical Systems, and Boston Scientific, and are centralized in the Southern District of West Virginia.
C.R. Bard is found negligent in its handling of TVM: it didn’t properly test the products (Avaulta) before putting them on the market. Johnson & Johnson’s Ethicon unit stops selling four lines of vaginal mesh devices and issues an Ethicon transvaginal mesh recall of its Gynecare line of TVM products, though the company maintains that the recall is not safety related.
More than 8,000 vaginal mesh lawsuits have been filed in federal and state courts. Three multidistrict litigations arising from transvaginal mesh cases are consolidated into one MDL.
2013
The FDA issues 95 study orders to a total of 34 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse (POP); and 14 post-market study orders to seven manufacturers of mini-slings for SUI.
Bellwether cases are resolved and settlements begin. Following a $2 million jury verdict against C.R. Bard, the company negotiates a settlement with an additional plaintiff.
With more than 8,000 transvaginal mesh implant claims in process, the first trial begins. Plaintiff claims 18 surgeries to correct problems associated with Johnson & Johnson’s transvaginal mesh product.
2014
The FDA proposes two orders for transvaginal mesh POP repair to address the risks involved. Once final, manufacturers will be required to provide clinical data in a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for transvaginal POP. If the orders are finalized and the mesh reclassified as a high-risk device, manufacturers will be required to submit a PMA (510k) application
November: Seven major TVM manufacturers are involved in an MDL in the U.S. District Court for the Southern District of West Virginia. Federal lawsuits are filed against American Medical Systems, Ethicon, Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic. According to the orders, the announced FDA actions only apply to mesh devices marketed for the transvaginal repair of POP. Surgical mesh devices for other indications, like SUI or abdominal repair of POP, are excluded.
2015
The jury’s first verdict against C.R. Bard, the manufacturer of Avaulta TVM, awards plaintiff damages of $3.6 million rather than a settlement.
Johnson & Johnson’s Ethicon trial is underway in a West Virginia federal court. The trial combines 37 cases as part of an MDL of more than 23,000 cases. Almost 80,000 lawsuits have been consolidated in six MDLs against a number of mesh manufacturers. Besides J&J, they are all working on settlements.
2016
The FDA announces that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the mesh devices.
The agency reclassifies transvaginal mesh products to treat POP only as Class III “High Risk Devices.” The FDA requires manufacturers to submit a PMA application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
Some advocacy groups, such as Public Citizen’s Health Research Group, criticize the FDA for allowing transvaginal mesh on the market. Based on the timeline for the new orders, devices that advocates say are potentially harmful will be able to stay on the market until at least 2018 - almost 10 years after serious complications with transvaginal mesh were first reported.
January: A jury awards one plaintiff $13.5 million in her transvaginal mesh lawsuit against Johnson & Johnson and its Ethicon subsidiary. (A plaintiff in December 2015 is awarded $12.5 million in her lawsuit.)
February: Johnson & Johnson settles between 2,000 to 3,000 TVM case of its 42,400 cases against the company with a $120 million settlement.
July 2018: Deadline for transvaginal mesh manufacturers to submit a PMA application for their devices.
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