The Food and Drug Administration is threatening Bayer with civil and criminal penalties if it doesn't better inform women about risks from one of the company's contraceptive devices.
Separately, Germany-based Bayer said on Monday that the benefit or risk profile of Essure had not changed and remained positive.
"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information", Gottlieb continued. The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. Sales of the device have declined sharply since the warnings were added, and Bayer stopped selling the device outside the US past year.
The new checklist is now legally required when the product is offered to the patient and must be signed by the implanting physician.
The FDA on Monday announced strict new requirements on the controversial Essure sterilization device, which already comes with a "black box warning", the strongest warning label the agency can require. The patient must be given the opportunity to sign as well. That is simply unacceptable. "Every single woman receiving this device should fully understand the associated risk".
The required brochure includes comparative information on various other contraception methods - IUDs; hormonal pills, patches, and implants; male condoms; female barrier devices; and the so-called rhythm method. During a procedure that can be done in a doctor's office, the coils are implanted in the fallopian tubes to scar them shut, preventing pregnancy. Adverse events such as perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions have been reported in some women after Essure implantation. "It does look like it's going to restrict Bayer's sales until they are in compliance".
As the manufacturer, Bayer must ensure that providers comply with the new restrictions, the FDA said.
Bayer in September 2017 said it had made a decision to discontinue the sale of Essure in all countries except the United States.
Further action may await completion of a postmarketing study the FDA ordered Bayer to conduct in 2016. Although Bayer's post-market study now has demonstrated adequate progress, including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume.
"We really weren't expecting the FDA to do anything that actually benefited women, so this was a huge move for the commissioner to make", Firmalino said. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.
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