Recent News Regarding Transvaginal Mesh

Bladder Health Awareness

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:

• GYNECARE PROSIMA™ pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE PROLIFT® pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE PROLIFT +M™ pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE TVT SECUR™ system used for stress urinary incontinence surgery

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 Continence’s (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 doctor’s experience with such repairs
3. Learn about the doctor’s ability to address any and all complications that may occur during and after the surgery.

Urethral Sling Material/Device for Stress Urinary Incontinence

Graft Reinforcement Surgical Options for Pelvic Organ Prolapse Repair

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