The agency will accept public comments on the language of a new black box warning, the strongest warning label the agency can require.
But many women who claim to have suffered serious complications after having the device inserted — including pain, perforation of the uterus, and even pregnancy — say that the FDA’s new recommendations are too little, too late. […]
“While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the FDA said in the statement. “These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.” […]
“We agree with the FDA that a new post-market study is needed,” Diana Zuckerman, president of the National Center for Health Research, told BuzzFeed News. “But we think the FDA should take over control of the study, because there’s so many questions about the previous studies on Essure being inaccurate and intentionally misleading.”
Because the device was developed as a permanent birth control option, women who have experienced serious side effects and wanted the devices removed have come across a big roadblock: there is no official protocol from Bayer on how doctors can remove the coils.
Some doctors will remove the coils through procedures like hysterectomies and cutting a woman’s fallopian tubes out. But Zuckerman notes that many recipients of Essure are poor women on Medicaid, and are less likely to have access to those doctors.
“When a low-income woman on Medicaid gets sterilized with Essure,” Zuckerman said, “if something goes wrong, the chances that she’ll find a physician who knows how to remove it safely are not very high.”
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