FYI: FDA Statement on Bayer’s announcement to halt Essure sales in the US

[Arcadia]

From https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm

“The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an orderrestricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness.

The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.

For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.”

From CNN https://amp.cnn.com/cnn/2018/07/20/health/essure-bayer-sales-stop-bn/index.html

“"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," according to Gottlieb.”

From Washington Post https://www.washingtonpost.com/news/to-your-health/wp/2018/07/20/sales-of-essure-birth-control-implant-halted-by-bayer-u-s-was-last-to-sell-controversial-device/?noredirect=on&utm_term=.0e7e97d24f1e

“In recent years, thousands of women have reported complications including autoimmune problems, unintended pregnancies and the migration of the coils into the pelvis or abdomen. Many said the problems were so severe that they had the devices surgically removed. Bayer has been served with lawsuits representing more than 16,000 patients, the company said earlier this year.”

[bethben]

This method was a possibility my gyn gave me years and years ago.  I thought it was too invasive at the time and now, I am glad I didn't go this direction!

[SamanthaCarter]

Yikes!