Types of Mesh

 

Transvaginal Mesh & Transvaginal Mesh Brands

At one point, nearly 40 companies were producing nearly 100 vaginal mesh products. The U.S. Food and Drug Administration (FDA) in the late 1990’s and early 2000’s approved transvaginal mesh implants as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Early on, these products were embraced by doctors as a simpler, easier way to create a long-term solution for women suffering from these embarrassing and often debilitating conditions. With nearly 500,000 of these surgeries performed each year, many medical device companies saw a potentially lucrative market to enter. Since the first transvaginal mesh product was approved by the FDA, dozens of vaginal mesh products have entered the market.

Paving the way for so many companies to produce multiple brands of mesh was an FDA decision to make transvaginal mesh a Class II product. This classification put a lighter burden on manufacturers to gain approval for their new products. Under Class II guidelines, and the FDA 510k program,  manufacturers are only required to show that the device they are producing is substantially similar to a product that has already been approved and is on the market. This made it very easy for manufacturers to quickly and easily bring new vaginal mesh products to market.

Although there are a large number of companies manufacturing vaginal mesh, there are five companies considered dominant in the market: Johnson & Johnson, Bard Medical, American Medical Solutions, Boston Scientific and Coloplast. These companies produce multiple brands through multiple subsidiaries, making billions of dollars in profit every year.

 

Johnson & Johnson/Ethicon Transvaginal Mesh Products

Johnson & Johnson was eager to jump into the emerging mesh market and created a new mesh product line through its subsidiary, Ethicon Inc. Ethicon was charged with developing “easy-to-use” surgical mesh kits. These kits provided doctors with pre-cut mesh and the tools needed for the implant procedure.

Surgeons embraced the convenient new kits. They quickly became the preferred treatment for prolapse and incontinence. Ethicon’s Gynecare brands were believed to be superior to traditional surgery, but doctors had many more complications than they expected. The surgical mesh was difficult to implant, and complaints of severe post-surgery complications were common.

Gynecare Prolift Kit

J&J started selling the Gynecare Prolift Kit for prolapse treatment in 2005 without marketing approval from the FDA. The FDA scolded J&J for breaking the rules but approved the Prolift anyway in 2008.

Gynecare TVT Secur

The Gynecare TVT Secure was the first mini bladder sling used in the United States. Instead of using needles, the U-shaped TVT Secur has built-in blades for attaching the mesh. However, the TVT Secur is more likely to loosen after surgery.

Gynecare Prosima Pelvic Floor Repair System

J&J tried to perfect the mini bladder sling with the Gynecare Prosima Kit. It uses slits cut with scissors to implant the mesh, instead of needles. A tiny balloon is then placed on top of the anchored mesh and inflated to support organs after surgery. The balloon is removed 24 hours after the operation. Because of the way it is attached, this mesh is useful only if incontinence is caused by organs dropping to the back of the vagina; it is likely to fail if organs prolapse toward the front.

Gynecare Prolift + M Kit

In another effort to avoid patient complaints of vaginal scarring and perforation J&J created the Gynecare Prolift +M to treat prolapse. It was the first surgical mesh in the United States to use plastic fibers that could be partially absorbed by the body. This mesh isn’t as dense as the Prolift, and it has larger holes that are supposed to help patients heal after surgery. The mesh also resists folding and wrinkling. Despite J&J’s efforts, the Prolift + M eroded and shrank, just like many of its other mesh brands.

 

Bard Medical Transvaginal Mesh Products

Like Johnson & Johnson, Bard Medical’s brands were approved under the 510(k) process. Bard even outsourced the clinical testing for its Alyte Y-Mesh device, relying on data from a 2010 European survey of 17 surgeons to get the brand approved by the FDA. Bard makes transvaginal mesh kits for both prolapse and incontinence.

Bard Transvaginal Mesh Products

Prolapse Repair

Bladder Sling

Alyte Y-Mesh Graft

Ajust Adjustable Single-Incision Sling

Avaulta Solo Anterior and Posterior

Align Urethral Support System

Avaulta Plus Anterior and Posterior

Pelvilace BioUretral Support System

Pelvicol Acellular Collagen Matrix (Pelvicol Pelvisoft Tissue)

Pelvilace Trans-Obturator BioUrethral Support System

Pelvisoft BioMesh

Uretex Self-Anchoring Urethral Support System

Pelvitex

Uretex Trans-Obturator Urethral Support System

Faslata Allograft

 

Endo Pharmaceuticals/ American Medical Systems’ Transvaginal Mesh Products

American Medical Systems made mesh for both stress urinary incontinence and pelvic organ prolapse throughout the 2000s. In 2011, the company was purchased by Endo Pharmaceuticals.

American Medical Systems Transvaginal Mesh Products

Prolapse Repair

Bladder Sling

Apogee

MiniArc Precise Sling

Perigee

MiniArc Single-Incision Sling

Elevate Anterior and Posterior Repair

Monarc Subfascial Hammock

InteXen

In-Fast Ultra Transvaginal Sling

IntePro

BioArc SP Sling

The Straight-In

BioArc Trans Obturator Subfascial Hammock

IntePro

SPARC Sling

Elevate with InteXen LP

InVance Male Sling

 

InteMesh

 

AdVance

 

Monarc Sling

 

Boston Scientific Transvaginal Mesh Products

The company has stated it still believes transvaginal mesh is an important treatment for incontinence and pelvic organ prolapse. Boston Scientific’s revenue was $7.6 billion in 2011, and transvaginal mesh sales made up less than 5 percent of the company’s revenue.

Boston Scientific Transvaginal Mesh Products

Prolapse Repair

Bladder Sling

Pinnacle Pelvic Floor Repair Kit

Advantage Transvaginal Mid-Urethral Sling System

Uphold Vaginal Support System

Prefyx PPS Sling

Polyform Synthetic Mesh

Obtryx Sling

Uphold

Lynx Sling

Arise

Advantage Mesh

 

Advantage Fit

 

Lynx Suprapubic Mid-Urethral Sling

 

Obtryx Transobturator Mid-Urethral Sling

The FDA ordered dozens of manufacturers to conduct studies on their mesh products, including Johnson & Johnson/Ethicon, Bard Medical, Endo Pharmaceuticals/ American Medical Systems, Boston Scientific and Coloplast. While each company makes its own version of transvaginal mesh many of the products are similar in both their design and the material used to construct the mesh.

Other Transvaginal Mesh Manufacturers and Products

Manufacturer

Products

Coloplast

Exair, Supris Suprapubic Sling, T-Sling, Aris Transobturator Sling, Restorelle, Minitape, Omnisure, Novasilk sling

Organogenesis

Fortaflex, FortaPerm

Pegasus Biologics

Orthadapt, Orthadapt, Bioimplant

Prosurg

Easy Lift, Minisling, Zippere

RTI Biologics

Tutopatch Tutomesh

Tyco Healthcare

IVS Tunneller

Covidien

Duo, IVS Tunneler, Parietene Mesh, Surgipro Mesh

Mentor

ObTape

Sofradim

Pelvetex, Uretex, Uretex Sling, UretexTO, Uretex TO Avaulta BioSynthetic System

PM Devices

PeriPatch

Serica Technologies Inc.

SeriScaffold

Surgicraft

Surgicraft Surgical Mesh

 

https://www.drugwatch.com/transvaginal-mesh/brands/