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Essure complications 8 articles

FDA orders Bayer to conduct post-market safety studies on Essure birth control

The Food and Drug Administration (FDA) is requiring Bayer Healthcare to conduct a clinical study for its nonsurgical permanent birth control device Essure to determine any heightened risks for particular women. Bayer was ordered to collect data on its contraceptive device following an FDA safety review prompted by a growing number of complaints involving the implant. The agency is also requiring a black box warning be placed on the contraceptive’s safety label. A boxed warning is the strongest warning the FDA can issue and is reserved for products where, if used, there is reasonable evidence of a serious health consequence or ... Read More

Representative introduces bills to protect women from dangerous medical devices

A bill known as Ariel Grace’s Law, designed to help women who claim they were injured by the permanent birth control device Essure fight back against the manufacturer of the device, was introduced on the House floor this week. This happened just as a second bill, called the Medical Device Guardians Act, was filed, giving physicians a more effective way of reporting problems with medical devices to the Food and Drug Administration (FDA). Both bills were introduced by Rep. Mike Fitzpatrick, who is helping raise awareness of the need for closer scrutiny of medical devices. He has taken up the fight for ... Read More

Health Canada investigates Essure birth control complaints

Just months after the U.S. Food and Drug Administration (FDA) recommended a black box warning be placed on the safety labels of the permanent birth control device Essure in response to thousands of complaints, Health Canada announced it would be conducting a safety review of the controversial contraceptive. Essure, made by Bayer Healthcare, is the only non-surgical permanent birth control method available in Canada or the U.S. It consists of two nickel alloy coils that are implanted in the fallopian tubes. The coils work with the body to form a scar tissue barrier that prevents the sperm from reaching the ... Read More

Essure complications can present years after implantation

Side effects from the controversial birth control method Essure have surfaced almost immediately for some women, but for others, problems arose years later. Essure is the only non-surgical permanent birth control method on the market. It consists of nickel alloy coils that are implanted in each fallopian tube where they create a barrier that prevents sperm from reaching the egg. The implants have been associated with thousands of adverse event reports including allergic reactions, autoimmune disorders, pain, bleeding and infections. The coils can also migrate and puncture the fallopian tubes or uterine wall and perforate other organs. In February, the ... Read More

Health Canada investigating safety concerns with Essure birth control device

Canada’s governing body over pharmaceuticals and medical devices is expected to announce in May its recommendations on whether to ban the Essure permanent birth control device or beef up safety warnings on the contraceptive’s safety label. Health Canada launched a safety review on Essure in November, just months after the U.S. Food and Drug Administration (FDA) began its probe into safety concerns with the device. In February, the FDA fell short of pulling the device, recommending its strictest warning – a boxed warning – be placed on the birth control device. The agency also ordered Bayer Healthcare, maker of Essure, ... Read More

Bayer faces mountain of Essure lawsuits

Bayer faces more than 30 lawsuits from women who claim the company’s permanent birth control device Essure caused them severe health problems, and the number is expected to climb as awareness about Essure complications increases. The lawsuits claim that Bayer failed to warn that the contraceptive implant could cause injuries including abdominal cramping, migraines, and abnormal menstrual bleeding. The device has also been linked to allergic reactions, autoimmune problems and infections. In some cases, the device has migrated from its intended position in the fallopian tubes and punctured organs. Essure was approved in 2002 and remains the only FDA-approved non-surgical ... Read More

Woman who claims she was injured by Essure birth control becomes health advocate

For Taylor Wells, choosing to use the Essure contraceptive was an easy decision. She had two young children and had just terminated a pregnancy due to complications. During a follow-up appointment with her gynecologist, they discussed several birth control options. Essure seemed the best option. It was only nonsurgical permanent birth control method on the market. The device, made by Bayer Healthcare, consists of two small nickel alloy coils that are implanted into the fallopian tubes, where they build up scar tissue that acts as a barrier, preventing pregnancy by preventing the sperm from reaching the egg. “Immediately after my ... Read More

Woman sues Bayer over Essure birth control injuries

Monica O’Neal, a young mother of two, said she asked her doctor about having a surgical procedure known as tubal ligation to permanently prevent her from having more children. Her doctor recommended a nonsurgical option, the Essure permanent birth control method, explaining that it would offer her faster recovery. Instead, she says the device left her seething in pain. “I woke up (from the procedure to implant the device) in excruciating pain and I can remember feeling like, I’m having a baby,” she said. That was 2010, and her first clue she had made a huge mistake. Six years later, ... Read More