The U.S. Food and Drug Administration has slowly reacted to events concerning polypropylene mesh for pelvic organ prolapse or POP.
These larger meshes packaged into one-size-fits-all kits have resulted in some of the most severe complications among the women who were permanently implanted. Estimates are up to 200-thousand woman received these PP mesh implants made by AMS, Boston Scientific, Johnson & Johnson and C.R. Bard. They are among the most difficult to remove and most agree the anchors that hold them in place are permanent.
POP mesh is used to support the pelvic organ that can drop or prolapse from their normal position. They include the vagina, cervix, uterus, bladder, urethra and rectum. A traditional repair, before mesh, involved suturing the organs in place.
Prolift, MedTech Marketing
All but a few have been quietly removed from the market
This week the FDA announced it will convene an expert advisory committee on POP in February to share the available evidence and hear from the public. *New Add*
Here are panel members.
Panel members will weigh in on the transvaginal placement of POP mesh in the anterior vaginal compartment - its risks and benefits and identify the appropriate patient population. Also physician training will be addressed.
There is no mention of the smaller but also problematic mesh for stress urinary incontinence (SUI) which largely remains on the market and which one largely industry funded medical lobbying group refers to as the Gold Standard.
Of the 150-thousand or so defective product lawsuits filed in the U.S. the majority are for SUI mesh.
Dr. Shlomo Raz, UCLA Urologist
The history of PP mesh is a short one but full of stories of pain and lives lost.
While PP mesh works for some people, at least in the short run, one of the world's experts in mesh removal says he stopped putting it in when he saw complications up to a decade later. Dr. Shlomo Raz now spends his years at the urology department of UCLA seeing the most seriously injured women from around the world.
Prolift, made by Johnson & Johnson, entered the market in March 2005, with no FDA clearance. The company felt it was similar enough to its polyproylene Polene suture already on the market so it didn't need to alert the FDA, according to discovery shown at trial. (Use Searchbar to see the Linda Gross trial).
By 2008, the FDA noted an increase in mesh-related injuries and concluded that pain, chronic infection, mesh shrinkage and erosion were “rare” occurrences.
By 2011, the FDA convened a public meeting of the Obstetrics and Gynecology Devices panel which decided that POP mesh complications are “not rare” and that POP mesh may not be more effective over traditional non-mesh repair.
The FDA agreed to review POP mesh on the market, a difficult task because there is no reliable and consistent post-market registry. The responsibility fell on the mesh manufacturers.
The FDA’s 522 orders, as they are called went to 34 manufacturers to find out how women were doing after their implant. Currently there are four ongoing 522 studies for five devices. Some such as J&J, opted to remove Prolift from the market by mid-2012.
The FDA then relieved the company of looking any further into the complications from Prolift recipients, despite the fact that the mesh was permanently implanted and for some, continued to do harm.
By January 2016, the FDA reclassified POP surgical mesh as class III, normally reserved for high risk devices, which many argue it should have already been considered. Class III means a manufacturer could not market its POP mesh unless and until it passed a higher level of scrutiny by the FDA known as premarket approval or PMA. The expert panel had suggested this move back when it met in 2011, five years earlier.
While most POP meshes were removed three surgical meshes for POP remain on the market while the FDA considers whether they should be there. They are Artisyn- Y-Shaped mesh, used for sacrocopopexy by Ethicon, Uphold Lite vaginal support system Boston Scientific, and Upsylon Y-Mesh by Boston Scientific. All are made of 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)