Mesh Medical Device News Desk, April 17, 2019 ~ Mesh News Desk is trying to clear up some of the confusion concerning Tuesday’s FDA decision about POP mesh applications to market denied!
There is a lot of confusion about the Tuesday announcement by the FDA to stop the sale of the remaining POP transvaginal meshes. See MND story here.
That included the Boston Scientific Uphold, Xenform and Coloplast Restorelle Direct.
Many polypropylene pelvic meshes remain on the market and are not affected by this FDA decision!
This includes meshes used to treat pelvic organ prolapse (POP), a condition where pelvic organs sag with gravity and need shoring up.
Deborah Kotz at the FDA informs Mesh News Desk that the Y-shape mesh is still marketed for the treatment of POP.
They include Artisyn Y shaped mesh made by Ethicon, Upsylon Y mesh made by Boston Scientific, and the Restorelle Y shape for sacrocolpopexy. These can be placed robotically or laparoscopically.
These POP meshes are used through an abdominal surgery are considered moderate risk and are considered Class II medical devices. They therefore do not have to go through premarket approval and clinical trials as mandated in the up-classification of transvaginal POP mesh by the FDA in 2016.
A surgeon can still choose a sheet of polypropylene mesh and cut her own mesh implant for an abdominal POP implant. Sheets of mesh, the same mesh used for hernia repair, are still Class II and available on the market.
Of course, all of the meshes used for stress urinary incontinence remain on the market including the TVT, TVT-O, TVT-Abbrevo, TVT-Exact (all Ethicon); Boston Scientific Advantage Fit, Lynx Suprapubic and Obtryx. These are “slings” that hammock the urethra then enter through the groin or through the abdomen.
Slings, POP mesh and hernia mesh are primarily fashioned from polypropylene (PP) and continue to be used despite the thousands of complications experienced globally that include chronic pain and infection, mesh shrinkage, sexual dysfunction, systemic autoimmune reactions, nerve damage and mesh erosion, among other conditions.
Hernia mesh implant in about one million patients a year are reporting these same complications and litigation is underway as is the recognition that this is becoming a major public health issue.
The FDA decision marks a stop but in no way signals the end of the use of transvaginal mesh as a whole!
As the public becomes more aware, women and men seeking hernia repairs are asking more questions but doctors too are providing more answers, some untruthful such as “it’s different mesh,” or the “bad stuff has been recalled.”
Mesh News Desk has heard these reports from the newly implanted people and it is unfortunate.
Ultimately, we may find that polypropylene is the culprit and, as a search for a better more biocompatible material is underway, patients offered a mesh implant should ask about their other options, whether their doctor can perform a native tissue repair, a suture alone repair, and whether the material offered is polypropylene.
If so, you might seek another opinion. ###
MND, April 16, 2019, FDA Orders Mesh Makers to Stop Selling Prolapse Mesh