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What Is A Vaginal Mesh, Transvaginal Mesh or Bladder Sling Implant?

Transvaginal mesh implants are surgical mesh implants used to treat or prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. POP causes the womb to fall into the vaginal area, and can also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, causing considerable pain and discomfort, as well as urinary incontinence in some cases. The vaginal mesh implants may also be used to treat incontinence.

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.

Vaginal mesh has been used since the 1950s to repair abdominal hernias. In the 1970s, gynecologists began using these products indicated for hernia repair for abdominal repair of pelvic organ prolapse (POP), and in the 1990s, gynecologists began using it for surgical treatment of stress urinary incontinence (SUI) and transvaginal repair of pelvic organ prolapse (POP). To do so, surgeons cut the vaginal mesh to the desired shape and placed it through a corresponding incision. Over time, in response to a perceived demand in the surgical community, manufacturers developed products specifically designed for SUI and POP. In 1996, the FDA cleared the first bladder sling like surgical mesh product specifically for use in SUI, and in 2002, the FDA cleared the first surgical mesh product specifically for use in POP. Over the next few years, vaginal mesh products for transvaginal POP repair became incorporated into “kits” that included tools to aid in the delivery and insertion of the vaginal mesh. Transvaginal mesh kits continue to evolve, adding new insertion tools, tissue fixation anchors, surgical techniques, and absorbable and biologic materials.

Surgical mesh products are currently regulated as Class II devices and are reviewed under the 510(k) Premarket Notification Program. The FDA’s premarket review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety. Bench and/or animal testing have been used to confirm that engineering specifications are met and that the material is biocompatible. Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products.

Vaginal mesh materials can be divided into four general categories:

·  non-absorbable synthetic (e.g., polypropylene or polyester)

·  absorbable synthetic (e.g., poly(lactic-co-glycolic acid) or poly(caprolactone))

·  biologic (e.g., acellular collagen derived from bovine or porcine sources)

·  composite (i.e., a combination of any of the previous three categories)

Most vaginal mesh devices cleared for urogynecologic procedures are composed of non­ absorbable synthetic polypropylene.

Vaginal Mesh FDA Warning

On October 20, 2008, the U.S. Food and Drug Administration issued an FDA Warning regarding serious complications associated with transvaginal mesh placement. The FDA warning stated that, over the last three years, it has received more than 1,000 reports from nine different manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence.

The FDA Executive Summery on Vaginal Mesh

In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients.

Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh. A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008 - December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions. Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.

The FDA also conducted a systematic review of the scientific literature to learn more about the safety and effectiveness of POP and SUI using surgical mesh. The FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN, and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.

The FDA is providing this update to advise the public and the medical community of complications related to transvaginal POP repair with mesh. The FDA plans to convene an advisory panel meeting of outside experts in September 2011 to discuss these findings and the types of clinical studies necessary to better assess the risks and benefits of using mesh to treat POP and SUI. In addition FDA is considering regulatory changes that may improve our understanding of the safety and effectiveness of this device.

The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.

To read more of the summary follow the link below.

FDA Executive Summary On Vaginal Mesh For Treatment of Women WIth Pelvic Organ Prolapsee And Stress Urinary Incontinence Study.

 

 

Ennis & Ennis, P.A. is investigating claims for all Vaginal Mesh Implants including the following major manufacturers:

Johnson & Johnson

Boston Scientific

  • Advantage Sling System
  • Arise
  • Lynx
  • Obtryx Curved Single
  • Obtryx Mesh Sling
  • Pinnacle
  • Prefyx Mid U Mesh Sling System
  • Prefyx PPS System
  • Solyx

C.R. Bard

American Medical Systems

  • Apogee
  • BioArc
  • Elevate
  • In-Fast
  • MiniArc
  • Monarc
  • SPARC

Acell Inc

  • Acell UBM Surgical Mesh ML and MLPlus

Brennen Medical, Inc.

  • Brennen Medical Surgical Mesh, Glucamesh/Glucatex
  • Brennen Biosynthetic Surgical Mesh Matrix

Caldera Medical Inc.

  • T-Sling
  • Caldera Mesh
  • Ascend Blue Mesh AC
  • Desara Mesh Sling
  • Popmesh

Carbon Medical Technologies, Inc.

  • Dermatrix Surgical Mesh

Coloplast A/S

  • Restorelle Polypropylene Mesh

GFE Medizintechnik GMBH

  • Timesh-TC

Herniamesh,Inc.

  • Herniamesh T-Sling

Injectx, Inc.

  • Biosling - Bioabsorbable Polymer Sling & Surgical Mesh
  • Cousin Biotech S.A.R.L.
  • p1 and Biomesh Plug and Patch

Kensey Nash Corp.

  • Bioblanket Surgical Mesh

Marketing Solutions Inc.

  • iPelvimesh/Hermesh 7

Mpathy Medical Devices, Inc.

  • Restorelle Polypropylene Mesh
  • Minimesh Polypropylene Mesh

Organogenesis, Inc.

  • Fortaflex Surgical Mesh

Promethean Surgical Devices

  • Hydrocoat Mesh

Prosburg, Inc.

  • Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System
  • Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh

Proxy Biomedical, Ltd.

  • Polyform Synthetic Mesh

RTI Biologics, Inc.

  • Tutopatch, Tutomesh

Sofradim

  • Pelvetex
  • Uretex
  • Ugytex Mesh/Pelvitex Polypropylene Mesh
  • Parietex Surgical Meshes
  • Parietex Optimized Composite Mesh & Parietex Optimized Composite Mesh (PCO-OSX References)
  • Parietene Duo and Quadra Polypropylene Meshes
  • Ugytex Sual Knit Mesh

Tepha, Inc.

  • Tephaflex Surgical Mesh

W. L. Gore & Associates

  • Gore Bioabsorbable Mesh

Xylos Corp.

  • Xylose Porous Surgical Mesh


Vaginal Mesh, Transvaginal Mesh, Surgical Mesh and Bladder Sling Lawsuit

Complications resulting from these implants may include the following:

  • Infection
  • Erosion of the mesh into the vagina
  • Recurrences of prolapse
  • Urinary problems
  • Bowel, bladder and blood vessel perforations
  • Injury to nearby organs
  • Pain during sexual intercourse
  • Pelvic pain
  • Extrusion of the mesh device

In many cases, implant problems have required multiple surgeries to remove the vaginal mesh. Even after surgery, women may be left with permanent and disfugiring injuries.

Vaginal Mesh Lawsuit - Lawyer

If you have had a Transvaginal Mesh or Bladder, Sling implanted and experienced serious side effects call our vaginal mesh lawyers today to find out if you meet the criteria for a vaginal mesh lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help victims nationwide. Let our Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.

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Ennis & Ennis, P.A. is currently handling cases for the following Vaginal Mesh Side Effects:

Infection

Erosion of into the vagina

Recurrences of prolapse

Urinary problems

Bowel, bladder and blood vessel perforations

Injury to nearby organs

Pain during sexual intercourse

Pelvic pain

Extrusion of the mesh device


If you have experienced vaginal mesh side effects you may be entitled to compensation. Contact the lawyers of Ennis & Ennis, P.A. today for information regarding your potential lawsuit or for information about a possible vaginal mesh implant class action lawsuit. Fill out our free case evaluation form and one of our Attorneys will contact you regarding your potential case.
Offices:
Washington DC Office
1101 Pennsylvania Ave.
Suite 600
Washington, DC 20004
Telephone: 202.756.2972
Miami Office
1111 Brickell Avenue
11th Floor
Miami, FL 33131
Telephone: 305.913.7199
Fort Lauderdale Office
110 E. Broward Blvd.
Suite 1700
Fort Lauderdale, FL 33301
Telephone: 954.315.3934
Facsimile: 954.315.3914


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