Clark, Love & Hutson, PLLC

FDA classifies transvaginal mesh devices as high risk

Many women in this Houston area have had issues with uterine prolapse. This is a common ailment for women who have had children. A transvaginal mesh implant has been commonly used to treat this condition but it has led to serious injuries in many women and has been considered a defective medical device by many.

Pelvic organ prolapse occurs when muscles in the pelvic region grow weak and are no longer able to hold organs up. This can cause embarrassing problems for women including incontinence. A transvaginal mesh implant is put in place to hold the organs up. But there have been many serious injuries reported by women who have had the device implanted. The injuries include infection, constipation and other injuries. The FDA recently announced that is now classifying these devices as "high risk" and will carry a class III warning. This means that the device has the highest risk of injury.

Thousands of patients have filed lawsuits against these medical device manufacturers Johnson & Johnson, Boston Scientific and Endo International. The individuals involved in these cases are seeking compensation for the negligence of these companies in manufacturing these defective devices. These cases are not always easy. They a review of the medical records, an investigation of the medical device manufacturer and a determination of what happened to cause the injury.

Still, these women and their families deserve answers. They can hold the medical device manufacturer responsible for their negligence and compensation may be available for medical expenses, pain and suffering and other damages. Medical devices have come a long way in a short amount of time. Most medical devices are safe and effective but occasionally some cause serious injuries. It is important for medical device manufacturers to be held responsible for their negligence so that they don't harm anyone else.

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