Health & Medical Pregnancy & Birth & Newborn

Contraceptive Implant Under Microscope Amid Questions of Safety, Altered Trial Data

Contraceptive Implant Under Microscope Amid Questions of Safety, Altered Trial Data

Contraceptive Implant Under FDA Panel Microscope


“These studies did not have a comparison group of women who did not get the Essure device, so the ability to conclude the relative rates of symptoms in Essure patients compared to other patients can’t be correctly done through these studies,” Maisel said.

Maisel said the FDA believes the benefits of Essure still outweigh the risks, and that all birth control choices have risks as well as benefits.

But to Zuckerman, telling a patient that the pain in the pelvis is definitely not related to the device is not defensible. “If you put something in the pelvic area, it’s ridiculous to assume that pelvic pain has nothing to do with it,” she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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