Bayer dismisses Essure concerns as safety, legal claims mount
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WH
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.
WIM
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.
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Forget science (for now); living longer is in your hands
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WH
Dr. Sanjay Gupta,
CNN Chief Medical Correspondent, writes in a
July 27, 2018 post that research shows only about 25% or our lifespan is explained by genetics.
WIM
Both the quality and quantity of our lives are very much in our own control, according to Dr. Gupta. When it comes to our longevity, we would be well-served to focus on nurture more than nature.
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CMS ends risk-adjustment freeze, releasing $10.4B to insurers
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WH
Evan Sweeney reports, for
Fierce Healthcare on
July 24, 2018, that the
Trump administration will release billions in risk-adjustment payments to insurers this fall, ending a relatively short-lived freeze that generated pushback from payers and providers alike.
WIM
"This rule will restore operation of the risk-adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,"
CMS Administrator
Seema Verma said in a statement. "Issuers that had expressed concerns about having to withdraw from markets or becoming insolvent should be assured by our actions today. Alleviating concerns in the market helps to protect consumer choices."
See the CMS announcement
HERE.
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| About Us |
Florida Health Industry Week in Review is published every Monday by
FHIcommunications.
Each Monday morning, we share the top healthcare headlines of the previous week and summarize
What Happened (WH) and
Why It Matters (WIM).
To learn how you can join our team of editorial contributors, contact
Jeffrey Herschler
.
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Inside FloridaHealthIndustry.com
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