The FDA says this warning is meant to increase understanding of the risks associated with the device for both patients and doctors. The label will include warnings of “perforation of the uterus and or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain and allergy of hypersensitivity reactions.” It also warns that some of the cases of reported adverse events required abdominal surgery. The proposed warning does not include ectopic pregnancies, miscarriages and babies stillborn. Nor does it mention that hysterectomy is sometimes required to correct internal damage caused by Essure.
Essure has caused the deaths of at least five unborn babies and four women, according to U.S. Rep. Mike Fitzpatrick. Essure recipient Angela Lynch told Drugwatch (Nov. 2015) that she had a hysterectomy to remove the device. And last fall, Emily had a hysterectomy because she believed it would be the only solution to having the device removed without leaving pieces of the coil behind and potentially harming a baby.
In August 2015 a doctor filed a report with FDA MedWatch Adverse Event Reporting database about a woman who died during Essure implantation due to necrotizing Streptococcus spp., an inflammatory infection associated with the device.
- About 900,000 Essure devices have been sold, according to Bayer.
- Of 62 percent of US women using some form of contraception, 25 percent of them choose sterilization.
- Essure is 99 percent effective at preventing pregnancy, according to Bayer.
- The FDA has received 631 reports of pregnancies in patients with Essure.
-150 of these pregnancies resulted in a live birth
-204 had no unknown outcome
-294 ended in “pregnancy loss” including 94 ectopic pregnancies, 43 elective terminations and 155 miscarriages.
(Pregnancy loss has been interpreted as fetal death: an analysis conducted by independent consultancy Device Events found that hundreds of fetal deaths were linked to Essure.)
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In Canada, a class action has been filed against Bayer, alleging it failed to adequately test the device in a way that would “fully disclose the magnitude of the risks associated with use,” and that failing to properly develop and test Essure increased the risk of side effects including “infections, perforated organs, implant migration, pelvic pain and autoimmune disorders.”
Health Canada is expected this month to announce whether to ban Essure or heighten warning risks on its safety label.