The US Food and Drug Administration (FDA) is continuing to review the safety of the permanent contraceptive device Essure (Bayer) and has provided an update on their efforts.
Marketed as a nonsurgical alternative to tubal ligation, Essure is a small, flexible metal coil that fits into each fallopian tube through the cervix and uterus. The ensuing inflammation and scarring permanently seal each tube within 3 months.
Since its approval in 2002, the FDA has received reports of adverse events with the device. In November 2016, the agency approved a boxed warning to the Essure label about the risk for implant perforation, device migration, allergic reaction, pain, and other possible adverse events.
In a statement issued today, FDA Commissioner Scott Gottlieb, MD, outlined steps the agency has taken thus far regarding Essure, and additional steps that are under way. He also reiterated his “commitment to regularly communicating with patients and physicians about this device as more information is made available and additional steps are taken.”
“As part of the FDA’s ongoing efforts to monitor Essure adverse events, we continue to review medical device reports submitted to our public database and provide updates about our ongoing analysis of the reports on our website,” Dr Gottlieb writes.
At present, the FDA is actively evaluating a “significant collection” of new medical device reports submitted to the agency on the Essure device, Dr Gottlieb reports. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year, he notes.
Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against Bayer, Dr Gottlieb says, adding that the FDA is working to evaluate whether these cases reflect “new safety concerns, as well as the extent to which they represent entirely new reports to the FDA or may have been reported in a prior safety filing.”
More than 90% of the reports in 2017 mention issues involving potential device removal, which the FDA is further investigating, Dr Gottlieb notes, although some of the reports do not state whether the device was removed.
“In short, we’re actively working to gain more information on these new reports and to better understand reasons for the device removal. The FDA will be following up on many of these individual reports to gather this additional information,” Dr Gottlieb writes.
He says the FDA continues to believe that Essure “may be appropriate for some women” based on current information, but the agency also recognizes that “serious problems” have been associated with its use.
The FDA says it will continue to monitor adverse events reported to their database, as well as other data sources, such as the postmarketing study, and will communicate to the public any new findings or concerns.
Dr Gottlieb added that the FDA will also “continue to consider regulatory options that appropriately balance the benefits and risks for the Essure device as new information becomes available” and will continue to communicate publicly on this issue, sharing what the agency has learned.
Bayer estimates that more than 750,000 women worldwide have been implanted with the Essure device since it was first approved by global regulatory authorities.
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