The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. To ensure the ongoing safety and efficacy of approved drugs and medical devices, the FDA may order manufacturers to conduct post-market surveillance studies. The FDA recently published the results of post-market surveillance studies of two medical devices affecting women: Essure and mesh slings.


Essure is a permanently implanted birth control device for women.  Unfortunately, numerous women reported adverse events related to the implant. Injuries include abdominal pain, abdominal bleeding, organ perforation, metal poisoning, and accidental pregnancy. Many patients ended up having the device surgically removed. As a result, the manufacturer, Bayer, stopped selling Essure in 2018. However, there was no formal device recall.

Since then, the FDA has continued to monitor Essure’ safety and effectiveness through post-market surveillance studies and medical device reports. Recently, the FDA updated safety information concerning Essure on its website. Unsurprisingly, the number of adverse events reported to the agency increased. Additionally, the number of reported device removals increased. All post-market information concerning Essure can be found here.

Vaginal Mesh Slings

Surgical mesh slings are medical devices implanted to treat female stress urinary incontinence. Sadly, thousands of women reported adverse events related to their mesh implants. Injuries include vaginal bleeding, abdominal and vaginal pain, urinary problems, infections, mesh migration, and organ perforation. In 2008, the FDA issued the first of many safety warnings on various types of slings. Subsequently, thousands of lawsuits were filed against several mesh sling manufacturers.

As a result, the FDA required manufacturers to conduct long term post-market surveillance studies on specific products, including mini-slings. Mini-slings are shorter than other types of slings.

The FDA recently completed its evaluation of the studies, as well as recent scientific and medical literature. Amazingly, the agency still deems mini-slings safe and effective for use. Despite numerous reports of adverse events, mesh slings have not been recalled and are still being used. Study results, as well as the FDA’s unchanged recommendations for use, can be found here.

If you or a loved one has been injured by the aforementioned products, contact the FDA. You may also want to consult an attorney.

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After reviewing your medical costs, lost wages, and pain and suffering damages, we can help you understand what your case is worth and plan a road map going forward.
After reviewing your medical costs, lost wages, and pain and suffering damages, we can help you understand what your case is worth and plan a road map going forward.

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