In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.
Bayer has said it doesn't know how many women have the implants, just that about a million Essure "kits" have been sold worldwide, most in the U.S.
The April action was a "unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device's safety and effectiveness", according to Gottlieb.
Essure is made of two inch-long flexible metal coils. We expect Bayer to meet its postmarket obligations concerning this device.
In their press statement, Bayer notes that the "increased reliance on other birth control options, such as long-acting reversible contraceptives, and inaccurate and misleading publicity about the device" is what contributed to the decline in interest for Essure. "I long expressed my concern that the product's risks were not being fully communicated to patients", stated Congresswoman Rosa DeLauro (D., Conn.) "Bayer's decision to take Essure off the market is a huge win for women and their health". About 750,000 women have been implanted with the device since its approval. Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure.
In a statement released Friday, agency Commissioner Dr. Scott Gottlieb said that "even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted".
October 2016: The FDA issued the final guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization" and in November 2016, the FDA approved updated labeling for Essure consistent with the guidance that added a boxed warning and a Patient Decision Checklist. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. A self-described "data advocate", she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product.
Bayer halted sales of Essure in every country besides the US last fall. It was not immediately clear what impact Bayer's decision would have on the studies. Not one more woman will be harmed by this device.
Bayer, however, maintains that other factors are behind the product's drop in popularity.