The FDA this week updated on its monitoring and investigations into issues related to Bayer‘s (ETR:BAYN) Essure contraceptive, saying it is currently evaluating approximately 12,000 reports received in 2017 related to the device, but that still believes the device to be appropriate for some women.
The agency said the total number of medical device reports it received in 2017 was 11,854, though it specified that the majority of those reports were submitted by the manufacturer.
“At the current time, the FDA is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device. 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,” FDA head Dr. Scott Gottlieb said in a press release. “We’re 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.”
The total number of MDRs the FDA has received related to the Essure contraceptive device is up to 26,773, according to an agency press release. In 2016, the FDA said it received a total of 5,019 reports.
The federal watchdog said that 78% of reports submitted last year by the manufacturer cited litigation, and that they may be referencing previously submitted reports.
A total of 92.7% of the nearly 12,000 reports submitted last year were related to device removals, the FDA said, adding that it is currently evaluating individual reports to “better understand reasons for the device removal and patient outcomes where that information is provided.”
The most frequently-reported patient problems were related to pain, or more specifically abdominal pain, with a total of 21,215 reports. Heavy menses or menstrual irregularities were also common with 9,846 reports, followed by headache with 7,231, fatigue with 5,842 and weight fluctuations, with 4,970, according to the FDA.
For device problems, the most frequently reported issues were possible nickel allergies at 4,481, migration of the device or its components at 2,396, dislodgment or dislocation at 1,356 and device breakage at 1,044. Devices operating differently than expected, difficulty to remove devices, difficulty to insert devices and malposition issues all received less than 1,000 reports, the FDA said.
A total of 48 reports were coded related to death, though the FDA said that eight of those reports were incorrectly coded. Of the 40 valid reports, 10 related to eight adult deaths, 23 related to 20 incidences of pregnancy loss, four related to incidents of the death of an infant after live birth, two related to incidences of ectopic pregnancies and one specified a death but did not state whether it was before or after birth, the agency said.
“We’ll provide updates on our evaluation of this data. The FDA will use the new information to continue to inform our assessment of the benefits and risks of Essure. We also rely on peer-reviewed medical studies to inform our thinking on Essure. Those peer-reviewed, published study results have been generally consistent with our previous assessments on the product’s safety profile,” Gottlieb said in a prepared statement. “While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use.”
Last September, Bayer said it halted sales of its Essure contraceptive device outside the US in response to “commercial reasons” and not due to safety or product quality issues.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.