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FDA Calls for Black Box Warnings for Essure Birth Control

doctor-talking-to-female-patientThe Food and Drug Administration (FDA) has ordered the addition of a black box warning – its most serious type – to the warning label for the contraceptive implant Essure. Thousands of women have issued complaints that the implant can lead to severe pain, bleeding and other health issues.

The nickel-titanium implants have been distributed for more than ten years. They are touted as the only nonsurgical option for women seeking permanent birth control.

Essure implants consist of two nickel-titanium coils that are placed inside a woman’s fallopian tubes. It promotes scar tissue growth that blocks sperm from fertilizing women’s eggs.

Although Essure’s current label warns of possible allergic reactions to the nickel, many women have attributed the device to much worse side effects. Many have reported severe back pain, organ perforation, severe fatigue, depression, pelvic pain and cramping, headaches, device breakage and more.

Additionally, the FDA has reviewed more than 600 reports documenting women who became pregnant after having Essure implanted.

Rather than remove the device from the market as many have called for, the FDA has required Bayer, the manufacturer of Essure, to conduct a study on the effectiveness and safety of the product. The study will include 2,000 female patients and will compare problems like unplanned pregnancies and pelvic pain in patients receiving Essure implants versus tube tying surgeries.

If you or someone you love has been injured by a defective product like an Essure implant, the skilled class action attorneys at the law offices of GWC Injury Lawyers can help you recover the compensation you deserve.