Bayer has announced that it will halt Essure sales in all markets with the exception of the United States. The female sterilization device has been linked to numerous instances of chronic pain, bleeding and other health problems, but Bayer insists that the decision is purely commercial, and is not ceasing sales due to medical or legal reasons. According to a statement from Bayer:
“We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue.”
Essure’s safety has been questioned frequently in recent years. The device was made available to the market in 2002 after gaining FDA approval. The FDA has reported a number of adverse effects connected to Essure:
Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.
Essure currently carries a “black box” warning, the highest level advisory issued by the FDA, and according to the Agency it “will continue to monitor the safety of this device to ensure that its benefits of continue to outweigh its risks.”
The FDA emphasizes that it has “taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device.”
Essure is marketed as a permanent birth control solution. The product is comprised of two nickel-titanium coils placed inside the fallopian tubes. The implant promotes the growth of scar tissue that blocks the tubes, preventing pregnancy.
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