April 13, 2012
Transvaginal Mesh Product Sold Without FDA Clearance
By Jonathan Damashek
Originally used to treat those suffering from an abdominal hernia, transvaginal mesh is a synthetic barrier that is used today to deal with cases of Pelvic Organ Prolapse as well as Stress Urinary Incontinence. Many women may face issues of their pelvic muscles and ligaments weakening as a result of age or other occurrences. This can cause the organs to begin dropping down, affecting the function of important parts of the body. This can lead to a number of uncomfortable and serious symptoms that in many cases may require surgery.
While the device has been a great benefit to many people that are suffering from these issues, there have also been many complications with the product that is causing additional problems in those that have undergone the surgery. For those that have experienced a personal injury as the result of a faulty transvaginal mesh product, the representation of a New York City injury attorney should be sought.
Since not every product that is out on the market ends up proving to be safe, the Federal US Food and Drug Administration requires a certain standard for an item to be cleared by them. While clearance does not guarantee the safety of a product, products approved by the FDA should always be sought since there is the additional protection provided by their inspection. One commonly known brand, Johnson & Johnson has their Gynecare Prolift vaginal mesh product out on the market. They have come under fire when it was brought to public attention as well as the attention of the FDA that this product was being sold for three years without being passed by the FDA. While the company tries to claim that they had clearance under the 510K for an earlier product, the FDA disputes the claim and says an additional 510K should have been sought for the Prolift.
During the time the item was on the market without clearance, tens of thousands of women underwent surgery for the product believing that it had passed regulations and gained clearance. Since the issue has become known, many medical professionals and consumers have come out claiming the issues they have seen with the product, further testifying to the lack of care that was taken by the company. If you or a loved one are suffering from an issue related to a transvaginal procedure, contact a lawyer from Hecht Kleeger & Damashek as soon as possible to learn more about how they can assist you when you have been wronged.