Recent News Regarding Transvaginal Mesh

mesh

Johnson & Johnson ETHICON Women’s Health & Urology, a worldwide leader in surgical care, has announced its decision to cease sales and production of four GYNECARE products. The products that will be discontinued include:

The discontinuation of these ETHICON products and such decisions by other companies to remove mesh products from the market are commercial decisions based on the high cost of conducting and collecting additional research data. The decisions aren’t due to safety violations or lack of product effectiveness, but by the new demands from the FDA for additional data on products and already approved by the FDA for use on the market. The discontinuation of the four GYNECARE products is not due to a voluntary or mandatory recall by ETHICON or the FDA. ETHICON informed the FDA and other worldwide health regulatory authorities of the decision Monday, June 5, 2012.

The National Association For Continences (NAFC) Position Statement For Vaginal Mesh in Pelvic Surgery

  1. Every patient is unique, the individuality of the patient and her input must be considered. Patient centered care lies at the heart of evidence based health care.
  2. The patient needs to be educated well enough to understand her diagnosis and treatment options. These should be discussed openly with the doctor so together they can agree on a course of action. This process is referred to as shared decision making.
  3. The medical societies must establish standards for surgery and training of doctors treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Patients should be educated to see proof of such training and be offered options in care.
  4. NAFC does not support the withdrawl of all mesh from the marketplace. Women who have already had mesh implanted surgically have no reason to have it removed unless they are witnessing severe complications, such as pain.
  5. Long-term analysis of data for improved knowledge is necessary.
  6. NAFC encourages open dialogue with all parties industry, providers, payers and patient advocacy groups on issues of patient safety and patient access to innovation for continuously improved quality outcomes in care.

More Information Regarding Surgical Mesh

Surgical mesh is used to repair weakened or damaged tissue. Because of better outcomes, surgeons often prefer to use mesh for anterior repair in the case of a cystocele (dropped bladder) or in case of prior prolapse and thus already compromised. In urogynecologic procedures, it is permanently impanted to reinforce the vaginal wall or to support the urethra. The mesh is porous but may be synthetic or biologic.

In 2008 and 2011, the FDA issued safety communications regarding the potential for serious complications associated with vaginal mesh, of all constructions, in pelvic surgery for prolapse. Before reaching a decision and consenting to a surgical procedure, patients are urged to:

  1. Educate themselves and ask their surgeons about all treatment options
  2. Learn about the doctors experience with such repairs
  3. Learn about the doctors ability to address any and all complications that may occur during and after the surgery.

Urethral Sling Material/Device for Stress Urinary Incontinence

American Medical Systems           

  • MiniArc™ Single Incision Sling System
  • MiniArc Precise Single Incision Sling System
  • BioArc™ System
  • Monarc™ Subfascial Hammock
  • SPARC™ Female Sling System
Cook Urological

  • Surgisis® Biodesign™ Urethral Sling
  • Surgisis® Biodesign™ Tension
  • Free Urethral Sling Kit
Bard Urological

  • Ajust® Adjustable Single-Incision System
  • Align® Urethral Support System
  • Pelvicol® Acekkykar Collagen Matrix
  • PelviLace® Biourethral Support System
Coloplast Corporation

  • Aris® Vaginal Sling
  • Supris® Sling System
  • T-Sling® Universal Sling
  • Axis™ Allograft Tissue
  • Suspend® Allograft Tissue

 

Boston Scientific

  • Advantage® Transvaginal Mid-Urethral Sling System
  • Lynx® Suprapubic Mid-Urethral Sling System
  • Obtryx® Transobturator Mid-Urethral Sling System
  • Prefyxd PPS™ System
Neomedic

  • ContaSure™
  • TRT® Remeex System

 

Caldera Medical

  • Desara™ Sling Material/Device
  • Hydrix™ XM
  • T-Sling with centrasorb

 

Ethicons Womens Health & Urology

  • GYNECARE TVT EXACT™ Continence System
  • GYNECARE TVT ABBREVO™ Continence System
  • GYNECARE TVT™ RETROPUBIC SYSTEM Tension Free Support for Incontinence
  • GYNECARE TVT™ OBTURATOR System Tension Free Support for Incontinence

Graft Reinforcement Surgical Options for Pelvic Organ Prolapse Repair

American Medical Systems

  • Apogee™ Vaginal Vault Prolapse Repair System
  • Straight-In™ Sacral Copopexy System
  • Perigree™ Prolapse Repair System
  • Elevate® Anterior & Posterior Prolapse Repair System
Caldera Medical

  • POPmesh™
  • Hydrix™ XM

 

Bard Urological

  • Alyte® 4-Mesh Graft
  • PelviSoft® Biomesh
  • Pelvicol® Acellular Collagen Matrix

 

Cook Urological

  • Surgisis® Biodesign™ Four Layer Tissue Graft
  • Surgisis® Biodesign™ Posterior and Anterior Pelvic Floor Grafts
  • Surgisis® Biodesign™ Vaginal Erosion Repair Graft
Boston Scientific

  • Polyform® Synthetic Mesh
  • Xenform® Soft Tissue Repair Matrix
  • Repliform® Tissue Repair Matrix
Coloplast Corporation

  • Restorelle® Polypropylene Mesh
  • Exair® Prolapse Repair System
  • Novasilk® Polypropylene Mesh
  • Axis™ Allograft Tissue
  • Suspend® Allograft Tissue
Mpathy Medical Device, Ltd.

  • Restorelle™
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9 Responses to Recent News Regarding Transvaginal Mesh

  1. DR GOURI KUMRA says:

    there should be a substitute for the sling.my concept a silicon look alike uterus if anchored to the stumps following hysterectomy, would minimize vault prolapse,urinary discomfort,and defaecation problem.CHARACTERISTIC OF THIS IMPLANT will be discussed if the idea is acceptable

  2. Urology is the medical and surgical specialty that focuses on the urinary tracts of males and females, and on the reproductive system of males. Medical professionals specializing in the field of urology are called urologists and are trained to diagnose, treat, and manage patients with urological disorders. The organs covered by urology include the kidneys, adrenal glands, ureters, urinary bladder, urethra, and the male reproductive organs

  3. Nanch says:

    Has the GYNECARE TVT tension-free support been recalled?

  4. Informative article, just what I was looking for.

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  6. gMxbG says:

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  7. Google says:

    Wonderful story, reckoned we could combine a few unrelated data, nevertheless seriously worth taking a look, whoa did one particular learn about Mid East has got additional problerms too

  8. Christina Toledo says:

    You have ruined my life Bard Pharmaceutical! Twice, two separate slings and both times you failed!

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