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Monday, Jul 23 2018

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Bayer To Stop Selling Essure Birth-Control Implant That Has Been Linked To Severe Injuries

Bayer cited a decrease in demand and said the decision was not related to the safety of the device or the thousands of lawsuits that have been filed against the company.

Bayer announced on Friday that it would discontinue sales of its Essure birth control implant by the end of the year, bowing to a lengthy campaign by health advocates and thousands of women to get the device off the market. The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it. (Kaplan, 7/20)

The German company had billed the device as the only non-surgery sterilization method for women. As complaints mounted and demand slipped, it stopped Essure sales in Canada, Europe, South America, South Africa and the United Kingdom. The U.S. Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place. (Perrone and Tanner, 7/20)

In April, the U.S. Food and Drug Administration tightened restrictions on the sale and distribution of the birth-control implant, requiring both patients and health-care providers to sign an acceptance-of-risk form. That move followed an FDA decision in 2016 requiring Bayer to add a prominent warning to call attention to serious risks associated with the device, after studies linked it to pain and other health issues among women. In April the FDA said since adding the warnings, Essure sales have declined about 70% in the U.S. (Mohan, 7/20)

In other women's health news聽鈥

The average woman has her period for 2,535 days of her life. That鈥檚 nearly seven years鈥 time of making sure you have a pad or tampon, finding a makeshift solution if you don鈥檛, and managing pain and discomfort. And lately, women 鈥 and transgender and nonbinary people who menstruate 鈥 are talking about it in public more than ever before. There are new products and services on the market, from menstrual cups to period underwear to medicinal cannabis and 鈥減eriod coaches.鈥 Globally, advocates are pushing for recognition of a woman鈥檚 right to manage her period with dignity. And in the United States, activists are bringing the concept of 鈥渕enstrual equity鈥 into the public debate. (Zraick, 7/22)

In 1998, 25 weeks into her pregnancy, Sara Arey's cervix dilated and her amniotic sac started to descend into the birth canal. She was rushed to a hospital an hour and a half away from her home near Hickory, N.C., where she stayed for more than a week before her baby was born via emergency C-section. The baby, a girl, died 12 hours later in the hospital. Arey had already had two prior miscarriages and one preterm birth in 1994. Had she been able to take a test for her risk of preterm birth, she says that she would have. She would have liked to have known her risk as early as possible, she says. (Watson, 7/22)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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