How is transvaginal mesh made?
Transvaginal mesh is a net-like ribbon or strip of material which is attached to weakened bladder neck or vaginal tissue. It can be categorized based on the type of material it is constructed from.
- Non-absorbable synthetic – Constructed entirely of synthetic materials like plastics or polyesters, that will permanently remain in the body. Over half of all transvaginal mesh products fit into this category and most of these are made from polypropylene.
- Absorbable synthetic – Constructed of a synthetic material that will degrade over time. As it degrades, the mesh is replaced by new tissue growth which may be stronger than before surgery. Examples of absorbable synthetics include polycaprolactone and polyglactin.
- Biologic – Constructed of animal tissue which has been processed and disinfected. Biologic mesh is usually degraded in a similar way to absorbable synthetics and will eventually be replaced by the body. Biologic surgical mesh is most commonly made from cow (bovine) or pig (porcine) tissue.
- Composite – May also be referred to as hybrid mesh, is a combination of absorbable and non-absorbable. Most commonly, this has been a non-absorbable synthetic coated with biologic tissue.
Discontinued Transvaginal Mesh
Transvaginal mesh products have been used in over a million female patients, many of whom have experienced severe complications. More than 100,000 lawsuits have been filed against manufacturers, causing companies to discontinue some transvaginal mesh brands.
Discontinued transvaginal mesh products include:
- ProteGen, made by Boston Scientific Corporation
- ObTape, made by Mentor Corporation
- Avaulta Plus, made by C. R. Bard Incorporated
- Gynecare Prolift, made by Ethicon, a Johnson & Johnson company
- Gynecare Prolift + M, made by Ethicon, a Johnson & Johnson company
- Gynecare TVT Secure System, made by Ethicon, a Johnson & Johnson company
- Gynecare Prosima Pelvic Floor Repair System, made by Ethicon, a Johnson & Johnson company
- Apogee Vault Suspension System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
- Apogee Pelvic Floor System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
- BioArc Sling System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
- In-Fast Ultra Transvaginal Sling, made by American Medical Systems (AMS)/Endo Pharmaceuticals
- Perigee System, made by American Medical Systems (AMS), acquired by Endo Pharmaceuticals
Who manufactures transvaginal mesh?
Ethicon Transvaginal Mesh
Ethicon, a subsidiary of the health giant, Johnson & Johnson, produces medical devices used in the surgical field. Ethicon offers a number of products for female pelvic organ health, including several transvaginal mesh brands.
Brand names of Ethicon’s transvaginal mesh products have included:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
Ethicon and parent company, J&J have been the target of several class action and multidistrict litigation (mdl) lawsuits, some of which are still pending.
Bard Transvaginal Mesh
C.R. Bard is a medical products company which manufactures, distributes, and markets numerous products associated with the treatment of female pelvic health conditions.
Brand names of Bard’s transvaginal mesh products have included:
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
In 2012, a court ruled against Bard Medical in the first major transmedical lawsuit. The case revolved around a female patient who underwent eight surgeries due to complications from a Bard brand transvaginal mesh implant. Infections, nerve damage and organ perforation have been associated with Bard brand transvaginal mesh on a frequent basis. In 2012, The FDA required Bard to pull its Avaulta mesh kit from the market for further testing.
American Medical Systems Transvaginal Mesh
Medical device company, American Medical Systems (AMS) was acquired by Endo Pharmaceuticals in 2011. After a number of legal setbacks, chose to close down all manufacturing of female pelvic health devices including the transvaginal mesh products. Its other medical device lines were subsequently sold to other manufacturers.
AMS/Endo transvaginal mesh products have included:
- Apogee Vault Suspension System
- Apogee Pelvic Floor System
- BioArc Sling System
- In-Fast Ultra Transvaginal Sling
- Perigee System
- SPARC transvaginal products
Though Endo is no longer manufacturing any of the AMS products, the company still faces thousands of lawsuits for transvaginal mesh injuries.
Boston Scientific Transvaginal Mesh
Boston Scientific manufactures a wide variety of medical products, surgical devices and supplies for science and technology. Boston Scientific’s ProtoGen Sling was one of the first transvaginal mesh products but was recalled in 1999 due to serious medical injuries.
Boston Scientific’s transvaginal mesh brands have included:
- Advantage Sling System
- Obtryx Curved Sling
- Obtryx Mesh Sling
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
Boston Scientific has already settled thousands of lawsuits for transvaginal mesh injuries but many remain in federal, state and local courts. Despite these difficulties, the company continues to manufacture a number of transvaginal mesh brands.