Transvaginal Surgical Mesh

MEDICAL ALERT: Another medical implant product is having issues and is causing thousands of women serious complications.

Transvaginal, or Urogynecological, surgical mesh implants are used to support and repair a weakened bladder or urethra in patients. The medical device is also used to reinforce and improve the function of the vaginal wall.

According to the Food and Drug Administration, alternative methods of providing support and repair for the fore mentioned conditions are still being investigated because of concerning side effects reported by consumers.

To date over 100,000 women a year are fitted with surgical mesh to offer additional support for conditions of pelvic organ prolapsed, despite other successful treatments made available within the medical community.

The side effects can be devastating and can cause severe pain, bleeding and urinary incontinence are just some of the side effects some patients experience after being implanted with surgical mesh products.

These products are being manufactured by Boston Scientific Corp. (BSX) and Johnson & Johnson, American Medical Systems (AMS), Cook, Covidien and C.R. Bard.

"The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn't be used routinely for all transvaginal prolapsed repairs," said Dr. William Maisel the FDA's deputy director of the Center for Devices and Radiological Health.

Of the 67,500 mesh medical devices implanted in patients last year, the FDA has been notified of over 1,500 instances of complication and adverse side effects, with some complainants seeking medical device failure damages against manufacturers and distributors.

"Even the FDA seriously questions the safety and effectiveness of these mesh products," deputy director of Public Citizen's Health research Group, said. Negative side effects noted by medical device attorneys and health care professionals have even included some instances of death as a result of the pelvic organ prolapse repair device.

Additional symptoms and adverse side effects documented by the FDA include:

• Infection
• Continual issues with prolapsed or incontinence even after device procedure
• Bladder, blood vessel and bowel perforation
• Dyspareunia
• Vaginal scarring

Although the medical device has not yet been recalled, non-profit organization, Public Citizen, is calling for the manufacturers of the transvaginal mesh to take action and the FDA has, similarly, issued a public health notification in October 2008.

The size, shape, materials and surgical techniques used have all been noted as factors that have provoked instances of serious injury, sometimes requiring the aid of a medical device attorney. Additional surgery may be needed to correct negligent procedures or replace poor quality mesh devices.

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