Wright & McGurk to Consumers: FDA Advisory Panel Classifies Transvaginal Mesh as High Risk

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Wright & McGurk is warning consumers of a recent FDA advisory panel recommendation to reclassify transvaginal mesh as a high risk device.

The FDA warned women that transvaginal mesh is a risky surgery whose results are less effective than traditional methods.

Wright & McGurk is warning consumers that transvaginal mesh continues to face scrutiny. Based upon the high number of complaints and alleged life altering consequences, an advisory panel to the FDA has looked deeper into the transvaginal mesh device. This advisory panel has recently recommended that transvaginal mesh be reclassified as a high risk device. This reclassification would force manufacturers to conduct rigorous testing to receive FDA approval to determine a device's safety prior to bringing the product to market.

Under the current system of 510(k) approval, products may gain immediate approval if they resemble previous products, even if their design is based on recalled products. As a result of this slapdash process, the number of surgeries to repair or remove faulty or defective transvaginal mesh is skyrocketing. Without the benefit of extensive product safety testing, women are facing dangerous and potentially irreversable complications.

In July 2011, the FDA warned women that transvaginal placement of surgical mesh is a risky surgery whose results are less effective than traditional methods. In a statement to the public, the FDA warned that the complications associated with transvaginal placement of surgical mesh could be irreversible. This includes significant risk of mesh erosion causing severe pain and discomfort. This condition is not rare and it can cause multiple surgeries, pain, and additional painful problems for women’s partners.

Transvaginal placement of surgical mesh is a polypropylene or xenograft (animal or human tissue) surgically implanted to strengthen the weakened vaginal wall. Introduced in the mid- 1990’s, this surgical procedure sought to permanently fix the problems that plague older women after childbirth, menopause, and hysterectomy. Prolapse occurs when the pelvic muscles weaken and the pelvic organs drop into the vagina. To repair this problem, a hammock shaped piece of surgical mesh is inserted into the vagina to support the organs.

The main problems that women experience are attributed to exposure of the mesh. Approximately 10% of women experience mesh erosion which could potentially lead to severe pelvis pain, painful sexual intercourse, or an inability to engage in sexual intercourse. Men may also experience pain during sexual intercourse due to the mesh erosion. In response to the thousands of reported problems, the FDA has released a warning that this device may expose women to significantly greater risks.

If you or a loved one has experienced complications as a result of your transvaginal mesh surgery, you may be entitled to compensation and equitable relief. Please call our firm today for a free and confidential consultation.

Extensive product liability experience gives attorney Candace McGurk the expertise necessary to handle your defective medical device case. She is a compassionate trial lawyer who fights for women’s rights. With over 20 years of experience as a trial lawyer, Candace McGurk is used to fighting defective medical device manufacturers and achieving results.

Wright & McGurk Law has over 30 years of experience fighting zealously on behalf of injured people and family members who have lost a loved one due to negligence. We are experts at fighting to achieve the fairness and justice our clients deserve. The lawyers at Wright & McGurk Law will not treat you like just another client. We are passionate about our role as your advocate and will treat you with the respect and compassion that you deserve. At Wright &McGurk, we understand that you may be in pain and we want to help get you the compensation you deserve. Cases are accepted nationwide; call us today for a free confidential consultation at (800) 471-0346. http://wrightmcgurk.com/

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Catherine Hess

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