As Bayer announces its plans to eliminate the Essure Expert Witness contraceptive market, experts are questioning the ethics behind paying Bayer doctors millions of dollars.
Paying doctors to prescribe “looks like bribes”
Last week, the United States Food and Drug Administration (FDA) revealed new safety concerns about Esau, and Bayer Pharmaceuticals announced on December 31 that the device would be pulled from the market.
To make matters worse, CNN’s analysis of federal data found that between August 2013 and December 2017, Bayer paid 11,850 physicians a $ 2.5 million Essure Expert Witness -related payment for consultation and similar services. Although technically legal, these payments are highly controversial.
Bayer paid more than $ 100,000 to three physicians for services linked to Essure.
In a statement to CNN, the doctor said his patients were “very excited” when the device was prescribed for patients who were badly affected by Essure-related side effects.
Ai. He added, “It looks like bribery. It looks like gaming the system. Looks like the pharm company is paying doctors.
Opinions differ as to why Essure was removed from the market
Friday, Bayer an “Essure Expert Witness patients about the provider’s Open Letter” issued, which Essure sales and ending the company’s decision “Essure the security and performance concerns are based on the claims. Essure 15 years, the market is in the hundreds of thousands of women who have successfully used Tuttukinranar. “
Notwithstanding, as indicated by an FDA report discharged that day, the gadget is “related with genuine dangers including relentless agony, penetrating of the uterus and Fallopian cylinders, and relocation of the winding hips or midriff.”
So far, the FDA has received more than 20,000 adverse event reports from women using Essure, of which 11,854 have been filed in 2018.
Oddly enough, Bayer’s announcement came just days before Netflix premiered the documentary “The Bleeding Edge” on the dangers of Essure and other medical devices.
Definite side effects and warnings
Since its approval on November 4, 2002, the FDA estimates that Essure has been used by more than 750,000 patients worldwide. At the time, it was manufactured and marketed by Essure Concepts Inc., which Bayer acquired in June 2013.
From 2002 to 2017, the most frequent patient problems reported to the FDA were:
• Pain / Abdominal Pain (21,215)
• Heavy menstrual/menstrual irregularities (9,846)
• Headache (7,231),
• Fatigue (5,842)
• Weight fluctuations (4,970)
As per the FDA, the detailed antagonistic occasions “can’t be clarified or utilized in disconnection to come to end results about the nearness, seriousness or recurrence of issues related with the gadget” and that “it is just hard to confirm that a gadget really caused a specific occasion.” Provided. “
In April, the FDA banned the sale of Essure only to physicians describing the dangers of FDA-approved patient education products. In May 2016, the FDA ordered a black box warning on product packaging.
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Permanent birth control
U.S. Court of Appeal in Essure Expert Witness Cases on Stopped Birth Control Device Nearly a dozen documents outlining Bayer’s transactions with the Food and Drug Administration are no longer confidential.
In a tentative ruling, Alameda County Superior Court Judge Winifred Smith partially removed a blanket protection order that contained approximately 70 million pages of discovery documents. If ordered, 16 court documents and a portion of a form will be made available to the public. The plaintiffs’ counsel alleges that Essure’s previous parent company, Conceptus, deliberately concealed records exposing the adverse side effects of the product.
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