Study Urges Tougher FDA Rules for Women’s Medical Devices

Women who used medical devices such as Essure permanent birth control, or underwent a surgical procedure involving a power morcellator had no idea they could possibly suffer irreparable harm. A recent study suggests that if the U.S. Food and Drug Administration (FDA) had more stringent approval processes, many women could have possibly avoided complications.

Extensive Research

In late May, researchers at Northwestern University studied nearly 20 medical devices that gained FDA approval between 2000 and 2015. According to the study, four devices were approved without demonstrating effectiveness and six gained approval without the need for post-marketing safety studies. Three of those devices were pulled from the marked due to either safety issues or other defects. The study focused on devices used for contraception, uterine bleeding and fetal monitoring.

Essure has led to many complications in women, including severe pain during intercourse and menstruation, device migration and more. The FDA mandated that Essure’s labeling provide additional warnings, but that edict came far too late for thousands of women.

A History of Issues

The study found that many medical devices have been approved using lax standards – and recent controversies have placed a harsh spotlight on the FDA’s approval process. Power morcellators, for example, have been found to spread malignant tissue throughout the abdomen, leading to the development of uterine and other forms of cancer.

One of the researchers summed the situation up perfectly, saying that the regulation of medical devices is a great deal weaker than drug regulation – “and it doesn’t make any sense.”

If you have suffered harm after undergoing a procedure using a power morcellator or use of the Essure birth control device, Baron & Budd may be able to help. Please complete our contact form or call 866-520-2755 for a confidential consultation.

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