Boston Scientific’s ProtoGen was the first vaginal mesh sling to be manufactured. The company pulled it from the market in 1999 after just a few years of sales over safety concerns. However, other manufacturers had by that point developed their own mesh products based on the ProtoGen’s design. These copycat devices made it to market through the U.S. Food & Drug Administration’s (FDA) 510 (k) fast-track approval process, which allows new products that are structurally similar to one previously approved to receive automatic approval without any oversight. The manufacturers of dangerous transvaginal mesh devices, which are based on a faulty prior-generation design, have been able to slide them into surgeon’s hands through this loophole. There is currently no legislation in place to prevent more of these dangerous vaginal mesh products from coming to market.

While a few products have been recalled, many are still being sold and implanted into women despite the fact that some manufacturers have known for years about the flawed, recalled ProtoGen. If you have received a vaginal mesh implant, this is information you should have been given prior to your surgery.

Obligation to Disclose

As protection for you, medical device manufacturers are required by the FDA to fully disclose the widest range of adverse effects that might occur from use of their devices. Manufacturers are supposed to tell your physician, and your physician should tell you, about all risks of transvaginal mesh of which they know or should know. Only with this information in hand can you weigh the benefits of a particular surgical procedure against the possible risks and consequences and decide whether you want it or not.

If the manufacturer of a medical device does not fully disclose the extent to which its device could harm you or your loved one, it is impossible for you to make an educated decision. You might choose to go forward with a procedure, completely ignorant of the fact that it could hurt you. You might never know to ask, “Is there another alternative that is less risky?”

In the case of transvaginal mesh products, this is exactly what has happened. Innocent women agreed to surgery thinking it was safe. Although the manufacturers knew, these women were never told that the mesh might fail inside their bodies and cause a cascade of worse problems or even death.

This failure to disclose can form the basis for a lawsuit against the manufacturer of your transvaginal mesh implant. It is important to know which manufacturer made the device used in your surgery before any legal action on your behalf can begin. Following is a list of vaginal mesh products by manufacturer with notes on those that have been removed from the market (meaning the manufacturer simply stopped selling additional units of the item) or recalled (meaning the manufacturer took back units of the item that had already been sold to doctors and hospitals).

Transvaginal Mesh Manufacturers

American Medical Systems (owned by Endo International)

• Prolapse Repair Products
  • Apogee (no longer sold in the U.S.)
  • Perigee
  • Elevate
  • IntePro Y-graft

• Incontinence Repair Products
• RetroArc Retropubic Sling
• MiniArc Precise Sling
• MiniArc
• Monarc Subfascial Hammock
• In-Fast Ultra Subfascial Hammock
• BioArc SP Sling
• BioArc Transobturator Subfascial Hammock
• SPARC Sling

C. R. Bard, Inc.

• Pelvilace
• Pelvitex
• Pelvisoft BioMesh
• Pelivicol Acellular
• Collagen Matrix Avaulta (no longer sold in U.S. as of July 2012)

Boston Scientific

• Prolapse Repair Devices
  • ProtoGen Sling (voluntarily recalled in 1999)
  • Pinnacle Pelvic Floor Repair Kit (Class II recall issued in Summer 2011)
  • Uphold Vaginal Support System
  • Polyform Synthetic Mesh
  • Arise Vaginal Support System

• Bladder Slings
  • Advantage Transvaginal Mid-Urethral Sling System
  • Prefyx PPS System
  • Obtryx Sling System
  • Lynx Suprapubic Mid-Urethral Sling System
  • Advantage Fit Transvaginal Mid-Urethral Sling System
  • Obtryx Transobturator Mid-Urethral Sling

Coloplast

• Pelvic Organ Prolapse Products
  • Exair Mesh
  • Novasilk
  • Restorelle
• Stress Urinary Incontinence Products
  • Altis Single Incision Sling
  • Aris Sling
  • Supris Sling

Cook Medical

• Biodesign Urethral Sling
• Biodesign Tension-Free Urethral Sling
• Biodesign Anterior Pelvic Floor Graft
• Biodesign Posterior Pelvic Floor Graft
• Biodesign 1-Layer Tissue Graft
• Biodesign 4-Layer Tissue Graft
• Biodesign 8-Layer Tissue Graft
• Biodesign Vaginal Erosion Repair Graft
• Biodesign Peyronie’s Repair Graft
• Stratasis Urethral Sling
• Surgisis Urethral Sling
• Surgisis Tension-Free Urethral Sling
• Surgisis Anterior Pelvic Floor Graft
• Surgisis Posterior Pelvic Floor Graft
• Surgisis 1-Layer Tissue Graft
• Surgisis 4-Layer Tissue Graft
• Surgisis 8-Layer Tissue Graft
• Surgisis Vaginal Erosion Repair Graft
• Surgisis Peyronie’s Repair Graft

Ethicon (division of Johnson & Johnson)

• Gynecare Prolift Kit (stopped manufacturing in August 2012)
• Gynecare Prolift + M Kit (stopped manufacturing in August 2012)
• Gynecare TVT Secure (stopped manufacturing in August 2012)
• Gynecare Prosima Pelvic Floor Repair System Kit (stopped manufacturing in August 2012)

Mentor

• ObTape Bladder Sling