Bayer pushed back on the clinical safety of its Essure contraceptive implant—a week after the company said it would pull the device from the market at the end of the year due to poor sales—as public and legal pressure continue to mount regarding reports of excessive fatigue, pain and bleeding.
The company characterized safety concerns as "based on anecdotal reports, rather than science," telling women and healthcare providers that no "reliable scientific evidence" exists to suggest new problems with the permanent birth control implant, and sought to minimize the FDA’s adverse event system.
"While Bayer takes any adverse event report seriously, the FDA has repeatedly cautioned that adverse event reports can be ‘incomplete, inaccurate, untimely, unverified or biased’ and duplicative, and that adverse event reports alone cannot be used to determine rates of events or causation," the company said in its statement.
The missive came hours before a CNN report that Bayer had paid thousands of doctors to recommend the device to patients. Federal data showed that the company paid 11,850 doctors $2.5 million over four years for Essure consulting fees and services.
In addition, a Netflix documentary premiered the same day—focusing on Essure, the larger medical device industry and patient-reported adverse events—titled The Bleeding Edge.
First approved in 2002, Essure is a pair of two-inch-long metal coils implanted through the cervix into the fallopian tubes, requiring no surgical incision. Scar tissue builds around the coils over three months, forming a barrier that stops sperm from reaching and fertilizing eggs. Bayer has estimated that more than 750,000 women have received the device worldwide.
In February 2016, the FDA ordered Bayer to conduct a postmarket safety study and added a boxed warning to Essure’s label. The agency also added a decision checklist to be completed by new patients, to make sure they had full knowledge of the device’s risks and benefits.
Since those changes, Essure sales have dropped by about 70%, the FDA said in April, when it moved to further restrict the sales and distribution of the device to providers that use the checklist.
The agency has seen a surge in safety reports related to Essure, driven largely by an increasing number of lawsuits, with more than 16,000 women suing Bayer over the device, according to Bloomberg.
FDA Commissioner Scott Gottlieb said the agency received 12,000 reports related to Essure last year, with over 90% related to potential removal of the device, which can require a hysterectomy.
"Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against the product sponsor," Gottlieb said in a statement earlier this year. "We appreciate any opportunity to receive additional information about the safety of this product."
Last week, Bayer said it would discontinue the device in the U.S., starting Dec. 31.
"This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable," the Leverkusen, Germany-based company said in a statement, citing declining birth control use overall and the rise of long-acting reversible contraceptives, as well as "inaccurate and misleading publicity about the device."
Essure has already been withdrawn from markets in the rest of the world. Bayer said it will continue to enroll patients in the required postmarket surveillance study.
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