Controversial Essure Device Gets FDA Scrutiny

Chris Newmarker

September 24, 2015

2 Min Read
Controversial Essure Device Gets FDA Scrutiny

Thousands of women have complained to FDA about abdominal pain, headaches, and other complications after having the Essure coils implanted in their fallopian tubes.

Qmed Staff

U.S. FDA's Obstetrics and Gynecology Devices Panel heard sometimes emotional testimony on Thursday as a string of women blamed a Bayer's Essure contraceptive device for ruining their health, according to media reports.

Chandra Farmer, 33, said she experienced muscle weakness so severe that she collapsed in front of her kids; she finally had a hysterectomy to remove Essure last year, according to The New York Times. Gabriella Avina, who once worked for the company and helped explain Essure to women, said she's changed her mind after going through celiac disease and myasthenia gravis.

Planned Parenthood and the American College of Obstetricians and Gynecologists still back the device, saying there have been few problems overall.

Edio Zampaglione, Bayer's vice president for women's health care, tells NPR that complications are rare with the nickel-titanium alloy coils. "What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it," Zampaglione says.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press.

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).

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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