Bayer to end Essure sales

23 July, 2018, 03:40 | Author: Sherman Richardson
  • Bayer to end Essure sales

Bayer has said it doesn't know how many women have the implants, just that about a million Essure "kits" have been sold worldwide, most in the U.S.

In its statement on Friday, Bayer said the "declining interest" in the device was attributable to the decreased use of permanent contraception overall, increased use of other birth control methods, and supposedly "inaccurate and misleading publicity about the device".

Bayer said Friday the safety of its Essure implant has not changed and it will stop selling the device at the end of the year due to weak sales.

The FDA has received 27,000 reports of injuries related to Essure implants in the past 16 years.

The Food and Drug Administration said earlier this year that over a 15-year period - November 2, 2002, when Essure was approved, through December 2017 - the agency received more than 26,000 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue. In April, the agency moved further, restricting Essure sales to medical practices that agree to inform patients of the risks involved.

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More than 16,000 US women are suing Bayer over Essure. The views expressed therein are not necessarily those of, its sponsors or advertisers.

New developments involving a controversial birth control implant that's prompted lawsuits from thousands of women.

Courtney Mallon, a spokeswoman for Bayer, said the "voluntary discontinuation" is not indicative of safety issues and added that the company is "working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported". They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. And we'll communicate publicly on any new findings or concerns. The company said it has gotten some thrown out, as well as narrowing the claims of the remaining suits. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.

Gottlieb noted that device removal "has its own risks".

Essure, a non-surgical sterilization device that is inserted into the fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing eggs, will no longer be available in the USA after December 31, 2018, Bayer announced in a statement. Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking. Those problems are listed in the current FDA labeling for the device, with the qualifier: "It is unknown if these symptoms are related to Essure or other causes". "Both the FDA and the company are responsible for a situation where women could not make informed decisions".



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