Essure Removed from Market, Experts Question Payments from Bayer to Doctors
As Bayer announces its plans to remove the contraceptive device Essure from the market, experts are questioning the ethics behind Bayer’s paying millions of dollars to doctors.
Payments Made to Essure Prescribing Doctors “Looks Like a Bribe”
Last week, the United States Food and Drug Administration (FDA) expressed new safety concerns about Essure, and Bayer Pharmaceuticals announced that they would be pulling the device off the market on December 31.
To make matters more alarming, a CNN analysis of federal data found that between August 2013 and December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services. While technically legal, these payments remain very controversial.
Three doctors were paid more than $100,000 by Bayer for services linked back to Essure.
In statements to CNN, a patients who suffered adversely from side effects related to Essure noted that her doctor was “very pushy” when prescribing the device.
Dr. Martin Makary, a professor of surgery and patient safety expert at Johns Hopkins Medicine, said that while payments from pharmaceutical company to doctors for research are not uncommon or unethical, he doubted that the more than 11,000 doctors paid by Bayer were involved in such work.
He added, “That looks like a bribe. That looks like gaming the system. That looks like the pharma company is paying of doctors.
Opinions Differ on Why Essure Was Removed from the Market
Bayer has announced that the reason they would be pulling the product is due to declining sales. adding that they completely stand by the safety of this product.
On Friday, Bayer published an “Open Letter to Patients and Providers About Essure,” which states that the company’s decision to stop selling Essure “was not based on concerns about the safety and efficacy of Essure. Essure has been on the market for more than 15 years and has been successfully used by hundreds of thousands of women.”
According to an FDA statement put out the same day, however, the device has been associated with “serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”
So far, the FDA has received more than 20,000 adverse event reports from women using Essure, with 11,854 of those reports being filed in 2018 along.
Oddly enough, Bayer’s announcement also came just days before Netflix premiered a documentary about the dangers of Essure and other medical devices, “The Bleeding Edge.”
Essure Side Effects and Warnings
The FDA estimates that Essure has been used by more than 750,000 patients worldwide since it was approved on November 4, 2002. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.
From 2002 through 2017, the patient problems most frequently reported to the FDA were:
- Pain/abdominal pain (21,215)
- Heavier menses/menstrual irregularities (9,846)
- Headache (7,231),
- Fatigue (5,842)
- Weight fluctuations (4,970)
According to the FDA, reported adverse events “cannot be interpreted or used in isolation to reach conclusions about the existence, severity or frequency of problems associated with devices” and “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”
In April, the FDA restricted sales of Essure to only doctors who give patients FDA-approved patient education materials that describe the risks. The FDA also ordered a black box warning be added to product packaging in May 2016.
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