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Ethicon Media Monitoring 11/23/2018
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FDA Convenes Panel on POP Mesh in February 2019
Nov 22, 2018 | Mesh Medical Device News Desk
By Jane Akre
The FDA continues to explore what went wrong with mesh for pelvic organ prolapse and will rely on the public and experts to weigh in in February 2019.
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FDA Convenes Panel on POP Mesh in February 2019
Nov 22, 2018 | Mesh Medical Device News Desk
By Jane Akre
The FDA continues to explore what went wrong with mesh for pelvic organ prolapse and will rely on the public and experts to weigh in in February 2019.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 kits in a one-size-fits all 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.
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.
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.
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.BACKGROUND
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 most experts in mesh removal says he stopped putting it in when he saw complications ten years later. Dr. 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. Discovery at trial has shown us that J&J didn’t feel it needed to alert the FDA because the basic PP suture material called Prolene had already received FDA clearance. (see 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 decidedthat 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.WHAT TO DOMark your calendar – A public turnout for this meeting will allow mesh recipients to talk directly to regulators.Enter comments into the Federal Register when it is posted. Mesh News Desk will will publishing the time and place and federal register locations.
Watch who is on the panel – Scrutiny of those selected to be on the panel will be watched, as in the past, some members looking to approve devices have been in financial conflicts of interest with the very companies they are reviewing.
https://www.meshmedicaldevicenewsdesk.com/fda-convenes-panel-on-pop-mesh-in-february-2019/
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