There is a lot of confusion about the April 16, 2019 announcement by the FDA to stop the sale of the remaining POP transvaginal meshes.
“Pelvic Mesh Off the Market” were the glaring headlines.
But that simply is not true.
Mesh used to treat incontinence, or stress urinary incontinence (SUI) as it’s commonly called, remains on the market and even one medical society, calls it the Gold Standard.
The majority of the product liability cases filed in federal court in West Virginia in multidistrict litigation and in various state courts are SUI mesh, which at this time numbers in excess of 126,000 cases.
Stress urinary incontinence mesh is sometimes called a “ribbon” or a “sling,” or a “hammock,” because it resembles a ribbon. It is made of polypropylene plastic and at about one inch wide and up to 18 inches long, transvaginal mesh is inserted through incisions in the vagina to cradle the urethra.
(A look at a youTube video and one would never undergo this procedure.).
The ends exit through the abdomen or groin.
This is a permanent medical device even though the U.S. Food and Drug Administration did not require any clinical trials.
We have the FDA’s 510(k) clearance process to thank for that oversight. A fast-track clearance to the market, it is intended to be the “least burdensome” path to the market.
The announcement last April concerns POP mesh, also known as pelvic organ prolapse mesh. This is a larger mesh made with more polypropylene and responsible for some of the most horrendous injuries. It too can never be removed.
In mid-2016, the FDA finally reclassified POP mesh as “high risk” from a moderate risk status (class II). That meant it had a higher bar to cross to the market. No more 510(k) fast track clearances, high risk meant it had to go through the same clearance as drugs, that is, clinical trials.
Most manufacturers simply removed their POP mesh from the market but a few held out hope.
That included the Boston Scientific Uphold, Xenform and Coloplast Restorelle Direct. The two companies had hoped their FDA mandated post-approval reviews would suffice for clinical trials.
In April, the FDA finally said No! Even though POP mesh dangers were discussed at an FDA expert panel that convened in September 2011, it took until April 2019 for the FDA to finally say No! You can’t enter the market without clinical trials.
Again, this FDA decision has no impact on the SUI meshes that remain on the market to treat incontinence.
For a woman who needs support of her pelvic organs that can fall with gravity and following childbirth, pelvic organ prolapse, there are alternatives. Suture repair is the standard and the Y-shaped mesh can still be implanted but through the abdomen, not the vagina.
These POP meshes are considered moderate risk and are 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.
With about one million hernia mesh implants a year, and complications emerging from some of those patients, we are beginning to understand that polypropylene mesh is 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.