FDA's New Restrictions for Essure: More Than Meets the Eye
Yesterday, the FDA issued an order restricting the sale and distribution of the Essure device to ensure that all women contemplating use of the sterilization device are provided with adequate risk information concerning the potential dangers of the device. Tens of thousands of Essure patients around the country rejoiced in the hard fought battle for this action to be implemented by the FDA. This "unique type of restriction" is based on a “review of a growing body of evidence” that led FDA to conclude “previous efforts to alert women to the potential complication of Essure” have not been enough to ensure they receive “this important information,” FDA Commissioner Scott Gottlieb said in a statement. The birth control product thus, “requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” Gottlieb added.
The new Essure labeling, which will now be legally required, restricts the sale and distribution of the device to only health care providers and facilites who provide the mandated information to patients about the risk and benefits of the device, "in the form and manner specified in approved labeling." This information must be signed by both the patient and the physician, and Bayer is required to ensure provider compliance. The FDA will enforce these requirements and will take appropriate actions, including civil and criminal penalties if necessary.
However, additional requirements were also imposed on Bayer which were not directly addressed in the FDA News Release. A strongly worded letter from FDA's Benjamin Fisher, Center for Devices and Radiological Health, to Bayer Pharma AG revealed several other requirements Bayer must comply with to continue to sell Essure. First, the FDA is also requiring a change in the product labeling to specify the specific training or experience practitioners need in order to use the device. This will hopefully curtail the use of the device by practitioners who do not posses the adequate training or skill to implant the device.
Additionally, the device labeling and any advertising must include the following warning: "The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer." The device is considered a restricted device and will be considered misbranded if the guideline are not followed. Further, Ben Fisher advised Bayer that, "continued approval of the PMA is contingent upon the submission of periodic reports of one year or less, from the date of approval of the PMA. Additionally, as of Septemenber 24, 2014, the reports must identify each device identifier currently in use for the subject device, and the device identifiers for devices that have been discontinued since the previous report. In addition, in order to provide continued assurance of the safety and effectiveness of the PMA device, the Annual Report must include, separately for each model number, the number of devices sold and distributed during the reporting period, including those distributed to distributors. This distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events. Although a more relevant number would be the number of devices implanted, this is an important requirment as Bayer has been manipulating the numbers of devices sold/impanted for years.
Finally, the letter reiterated the requirement for Bayer to report adverse events concerning Essure to the FDA, no later than 30 days after received by Bayer. The strongly worded letter also reminded Bayer that, "device labeling must be truthful and not misleading." Also noted was "failure to comply with any post-approval requirment constitutes a ground for withdrawal of approval of a PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in compliance with its conditions of approval is a violation of law."
Bayer was cautioned that as soon as possible and before commerical distribution of your device, you must submit an amendment to this PMA submission with copies of all final labeling. It appears that the sale and distribution of Essure is temporarily suspended until such labeling changes occur, much to the elation of Essure victims around the country.