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