WASHINGTON (AP) — Federal health regulators plan to warn consumers more strongly about Essure, a contraceptive implant that has drawn thousands of complaints from women reporting chronic pain, bleeding and other health problems.
The Food and Drug Administration announced Monday it would add a boxed warning — its most serious type — to alert doctors and patients to problems reported with the nickel-titanium implant.
But the FDA stopped short of removing the device from the market, a step favored by many women who have petitioned the agency in the last year. Instead, the agency is requiring manufacturer Bayer to conduct studies of the device to further assess its risks in different groups of women. […]
The proposed warning label will also take time. The FDA is seeking public input for 60 days on the language for the warning and another proposed “check-list” that doctors would use to make sure patients understand the device’s risks.
“We strongly support a black box warning, but it needs to be a very strong one,” said Diana Zuckerman of the National Center for Health Research. […]
Essure’s warning label previously noted that the device’s nickel can result in allergic reactions, such as itching and hives.
But many women have attributed more severe problems to the implant, including mood disorders, weight gain, hair loss and irregular bleeding. Many of those complaints have been shared through social media, including a Facebook page called Essure Problems, which has grown to over 27,000 members. […]
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