Mesh Medical Device News Desk, February 11, 2019 ~ Today, February 11th, is the last day to submit comments to the Federal Register as the FDA convenes its Obstetrics and Gynecology Devices panel Tuesday to decide the future of transvaginal pelvic mesh used to treat pelvic organ prolapse (POP).
Industry and the anti-mesh community will testify to an expert panel gathered Tuesday as two mesh manufacturers attempt to convince the panel to keep three POP meshes on the market.
They include Boston Scientific’s Uphold LITE and Xenform, and Coloplast’s Restorelle DirectFix Anterior mesh.
Image: Rectocele, FDA
POP mesh is larger than mesh used to treat incontinence and is placed through the vagina to support the colon, uterus or bladder from prolapsing through the pelvic floor.
Transvaginal mesh, (placed through the vagina), to support the urethra to treat incontinence will not be the subject of this advisory committee made up of medical doctors, industry and patient reps. It is a smaller mesh, also sold in kits and referred to as the Gold Standard treatment by at least one medical society.
The FDA does not have to follow the advice of its expert panel but usually does.
Three years ago, POP mesh was reclassified by the U.S. Food and Drug Administration (FDA) as “High Risk” or class III due to the high numbers of complications being reported to the agency.
In response, the FDA required 33 companies to conduct post approval monitoring studies and industry quietly removed from the market three of the worst offending POP meshes including Ethicon’s Prolift, Boston Scientific’s Pinnacle and Bard’s Avaulta pelvic mesh kits. In doing so, they were relieved of conducting any post approval monitoring.
59 COMMENTS – THE FEDERAL REGISTER
View the comments from the Federal Register here.
With more than 104,000 product liability lawsuits consolidated in federal court in West Virginia, as of today there are only 59 comments. They include Dr. Vincent Lucente, MD, a preceptor for Ethicon who in court testimony has admitted to being paid at least $2 million by the company.
Here’s the link to the Federal Register to submit:
The Meeting will be at the Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D
620 Perry Pkwy. Gaithersburg, MD 20877
Time: 8:00 am ET to 6:30 pm
Note the proceedings will be called to order at 8 AM. At 8:30 AM the public will be invited to testify in 5 minute statements until approximately 10:00 AM. Then after lunch, manufacturers are given approximately one-half hour to present information on the particular meshes they would like to reintroduce into the marketplace.
After an afternoon break, the panel will deliberate at approximately 3 pm. Here are the questions the panel will consider. The meeting should adjourn at 6:15 PM.
The public can watch in a webcast with the meeting scheduled to start at 8:00 AM EST. The Webcast will be on-line at 7:00 AM EST so you can log on and check your system. Use Google Chrome as your browser. No password is required.
In September 2011, an FDA expert panel concluded mesh placed transvaginally to treat pelvic organ prolapse did not have a “well-established benefit/risk profile,”
“It is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair,” said the FDA on July 13, 2011.
After counting the growing numbers of complication reports, the FDA concluded POP mesh complications were “not rare.”
By 2016, the FDA moved to reclassify POP mesh from Class II or moderate risk, to Class III or high risk. Incontinence mesh remains a moderate risk Class II even though at least half of the defective product lawsuits are due to incontinence pelvic mesh, also known as slings.
The agency also gave industry 30 months before it had to submit safety studies or remove its mesh from the market. Earlier the FDA ordered 34 mesh makers to conduct post approval studies, called 522 studies to assess the health of women who had received a mesh medical device. Instead, most POP meshes were removed from the market, relieving the company of the 522 study requirement.
The 30 month time frame concluded in July 2018. See story here.
Four of the postmarket surveillance studies for five surgical meshes are currently ongoing.
Among those testifying are Madris Tomes of Device Events. Formerly an IT project manager in its adverse event reporting program, she created her own more user-friendly database after leaving the FDA. Today, she investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.
Tomes will testify that through January of this year there have been more than 139,000 adverse events reports for mesh products with 1,107 patient dying. The rest of her report is embargoed until after her presentation. MND will report its contents then.
Mesh injured women have vowed to have their voices heard before the FDA panel, but some tell Mesh News Desk, they are too sick to travel or are unable to afford the trip.
While polypropylene (PP) mesh works for some people, at least in the short run, one of the world’s experts in mesh removal, UCLA urologist, Dr. Shlomo Raz, has stated he stopped putting it in when he saw complications up to a decade later.
Mesh trials have proven that traditional polypropylene mesh had a small pore size of less than 1 mm which caused bridging fibrosis or a scar plate that would cause the mesh and surrounding tissue to shrink, causing pain. That with injuries during placement, chronic infections, nerve damage, mesh erosion have led to personal injury trials yielding millions in awards to injured plaintiffs.
Interestingly, the meshes that industry will try to keep marketing have a larger pore size.
Uphold LITE Boston Scientific – A light weight PP mesh with a pore size of 2.8 mm smaller mesh footprint is used for anterior and apical compartments with a trocar-free approach. Boston Scientific has upgraded its warning to physicians here.
Xenform by Boston Scientific is a bovine (cow) dermis xenograft used for POP repair.
Coloplast Restorelle DirectFix Anterior is called a “Smartmesh technology” in an “ultra-lightweight mesh.” It too is polypropylene.
FDA Announcement, November 20, 2018
2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel
December 2015, Orders Federal Register, PMA required by July 5, 2018 for POP mesh, Class III
Mesh News Desk, July 10, 2018, 30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many
Federal Register, January 5, 2016, Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use with Urogynecologic Surgical Mesh (here)
FDA Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, July 2011 (here)
FDA, Concerns about Surgical Mesh for POP, July 13, 2011 (here)
MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders (here)
MND, March 2013, SUI Injury Reports to FDA up 36 Percent (here)
FDA Final Order – Letter to mesh makers for 522 studies, January 2012 (here)
MND, January 9, 2012, Mesh Makers who Received FDA Letter Requiring Postmarket Surveillance (here)
MND, AUGS Prolapse Consensus Conference Announced with Patient Advocates, October 16, 2016 (here)
Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” from the Pelvic Surgeons Network, January 2012 (here)
MND, What Happened to the FDA Request for Transvaginal Mesh Studies? September 19, 2012 (here)
June 4, 2012, Ethicon letter to Judge Goodwin, it plans to stop commercialization of four meshes (here)
MND Mesh-Injured Patient Researches ProteGen Mesh Predicate, November 8, 2011 (here)
News Release, April 4, 2018, Female Pelvic Implants Market to reach a value of over US $300 Mn by the End of 2027 (here)
BMJ, December 2017, Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process (here)