MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

The Revolt Against Bayer's Essure

As with laparoscopic power morcellators, something appears not right when it comes to a device that has seen widespread use over the years.

Qmed Staff

Arrow  back

Bayer claims that only a small portion of the hundreds of thousands of women implanted with its Essure contraceptive device have had a bad experience with it. But the needle appears to be moving amid vocal criticisms from thousands of women reporting problems.

FDA has received nearly 6000 reports of problems related to Essure, many listing multiple health problems. They include pain/abdominal pain (3353), menstruation irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). 

Erin Brockovich has helped lead protest against the product and has organized a petition that to date has received nearly 16,000 signatures. Testimony was emotional during a September meeting of FDA's Obstetrics and Gynecology Devices Panel.

FDA has described the issue as high priority, with the agency's next steps expected at the end of February. 

In September, an FDA advisory panel recommended more limited use of Bayer's Essure contraceptive device amid complaints of health problems.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.