Bayer is standing by the safety of its permanent birth control device, Essure, despite pulling it off shelves. In mid-July, the company announced its decision to halt the sale of Essure by the end of the year. Ceasing the sale of the device ends the battle between the company and detractors. Thousands of women filed lawsuits against Bayer attributing persistent pain and perforations of the uterus and fallopian tubes to the device.
Bayer, however, claims the halt of the sales was a move that resulted from a decline in sales. The company says that sales have declined by as much as 40 percent.
The U.S. is the last country Essure is being sold. In September 2017, Bayer announced it was ending sales outside of the United States.
Bayer is a major pharmaceutical company with a long history of controversial drugs and devices. In the 1980s, the company single-handedly infected thousands of hemophiliac patients with HIV after selling a contaminated blood-clotting product. However, most recently the company is standing by its Essure device, despite pulling it from shelves. The device is responsible for injuring thousands of women who were looking for permanent birth control.
The company released a press release that calls the adverse events women have reported as ‘anecdotal’.
“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. Indeed, in 2015 FDA reviewed the safety data for Essure and did not identify new safety or efficacy concerns,” Bayer wrote in a press release.
The statement from Bayer comes on the heels on a flurry of bad press from a new documentary released to Netflix and CNN report. “The Bleeding Edges” takes a closer look at the complications in women who opted for the device. The film further documents their quest to get the U.S. Food and Drug Administration (FDA) to take action.
In addition, the company is facing blowback from a newly released CNN report. CNN released a report alleging the company paid more than $2.5 million to doctors. The payments were to push the Essure device on patients.
Between August 2013 to December 2017, Bayer paid 11,850 doctors $2.5 million in Essure consulting fees and other similar services. While these payments are legal, they are extremely controversial.
Patients report doctors being cheerleaders for the device while pushing it as the only option for permanent birth control. In the CNN report, Christina Potts wonders if her doctor pushed the device because it was best for her or because Bayer paid her tens of thousands of dollars. As a result of the device, Potts had to have a hysterectomy to remove her uterus and fallopian tubes to get rid of Essure.
Potts’ doctor, Dr. Cindy Basinski, was one of the highest paid doctors from Bayer’s Essure fees. Federal data shows Basinski was paid $168,068 for consulting fees and similar services from 2013 through the end of 2017.
Basinski says that she is so confident in Essure’s safety that she will continue to implant the device until the device comes off the market later this year.
Women who underwent an Essure procedure and experienced health complications should know that they have rights, including the right to take legal action against Bayer. If you or someone you know have suffered these serious injuries from the product, contact our team of defective product attorneys immediately for a free consultation.
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