Prolene Hernia System explant from Rosenberg, 1.5 years
Mesh Medical Device News Desk, January 4, 2017 ~ The origin of the female surgical mesh devices is hernia mesh. It was assumed prolapse was simply the female form of a hernia.
Is all surgical mesh the same?
By now readers of Mesh News Desk understand whether mesh is used for hernia repair, to treat stress urinary incontinence or pelvic organ prolapse, pelvic mesh and hernia mesh is usually made of polypropylene.
Surgical mesh materials can be non-absorbable, absorbable, biologic or a composite. Animals are used to source biologic mesh, generally pig (porcine) or cow (bovine). The intestine or skin is processed and disinfected before being used as an implanted medical device.
Synthetic mesh, such as plastic polymeric polypropylene is more widely used to treat hernias and for gynecologic use, largely because it’s inexpensive and available.
Prolene Hernia System, sold by Medical Solutions
Polypropylene (PP) mesh
It is a polymer that originated from the oil industry and was isolated for all sorts of uses in the 1950s, including automotive components, carpets, clothing and structural foam, even the lid of a Tic Tac box. PP’s recycling code is a “5” inside the recycle symbol.
PP resin pellets are made into mesh threads and because of its low cost, PP has become the world’s second-most widely produced petroleum-based plastic after polyethylene.
Non-absorbable synthetic mesh is considered a permanent implant and intended to remain in the body indefinitely to provide reinforcement to a weakened abdominal wall, an incision site or prolapsing pelvic organs.
In the 1970s, gynecologists began to retrofit hernia mesh for gynecological use.
It was assumed POP (pelvic organ prolapse) was simply a female version of a hernia, where the uterus, colon or bladder dropped outside the body. The same principles applied - implant the surgical fabric to shore up the descending organs due to the force of gravity and the failure of weak connective tissues.
C-Qur Mesh animation, YouTube
The first surgical mesh used for female incontinence was ProteGen by Boston Scientific, approved by the FDA in 1996.
But the material, a woven polyester with pressure-injected bovine collagen, was voluntary removed from the market in 1999, branded as adulterated and misbranded, in other words defective.
That didn’t stop at least 60 newer meshes to be cleared by the FDA using ProteGen as a “predicate.”
Naming a predicate is all that is required under the FDA’s fast-tracked 510(K) clearance process. Hernia and pelvic meshes are all classified as Class II or moderate risk, even though safety and efficacy was never established through clinical trials.
Ulf Ulmsten, MD
By 1998, Ethicon, a division of Johnson & Johnson, played catch up with its Tension-Free Vaginal Tape (TVT). An enterprising Swedish gynecologist, Ulf Ulmsten, MD, approached Ethicon about creating a product to treat stress urinary incontinence (SUI).
Using the Ethicon Prolene hernia mesh, he created the first TVT mesh to treat SUI.
The 2002 Gynemesh, PS, another hernia mesh was configured to become the first surgical mesh to treat POP.
The next evolutionary phase were prepackaged “kits” that would include tools, such as stainless steel trocars, to insert the mesh. The first kits for POP repair were made by American Medical Systems. The AMS Apogee and Perigee System were cleared under 510(k) in 2004.
Along the way, the FDA did not require any additional evidence of safety or efficacy.
Between 1992 and 2010, the FDA cleared 168 applications for surgical hernia mesh for urogynecologic use.
With more than one million hernia repairs in the U.S. annually, non-mesh repairs now represent less than 10 percent of groin hernia repairs, according to the FDA.
What’s interesting is the complications for hernia repair mesh are virtually identical to complications from transvaginal mesh - pain, infection, scar formation, fistulas, mesh erosion, migration, perforation of organs, mesh shrinkage and a recurrence of the original condition. The consistency is often the polypropylene material used for both meshes.
Surgical mesh has become a multi-billion dollar industry that is growing in the U.S., India and China with no signs of slowing down. ###