Bayer to stop selling Essure birth control device in US

Bayer will no longer distribute or sell the Essure permanent birth control device in the United States after December...

Posted: Jul 21, 2018 11:11 AM
Updated: Jul 21, 2018 11:11 AM

Bayer will no longer distribute or sell the Essure permanent birth control device in the United States after December 31, the company said Friday.

Essure, the only non-surgical permanent form of birth control for women marketed in the US, is inserted into the fallopian tubes, where scar tissue forms and builds a barrier to block sperm from reaching -- and fertilizing -- a woman's eggs.

Bayer will no longer sell or distribute Essure as of December 31

Essure is the only non-surgical permanent form of birth control for women marketed in the US

The company's decision follows the US Food and Drug Administration's patient safety action in April, when it ordered that sales and distribution of Essure be restricted, FDA Commissioner Dr. Scott Gottlieb said Friday after the Bayer announcement.

"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.

The FDA's April action was a "unique type of restriction" in which it imposed additional requirements "to provide a reasonable assurance of the device's safety and effectiveness," Gottlieb said.

Dr. Yesmean Wahdan, an obstetrician/gynecologist at Bayer US Medical Affairs, Women's Healthcare, said in a video statement Friday that the company "made a business decision to discontinue sales and distribution because of a decline in sales."

Courtney Mallon, a spokeswoman for Bayer, said the "voluntary discontinuation" is not indicative of safety issues and 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."

Bayer reiterated Friday that "The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades."

The news was welcomed by women who have advocated against the device.

"Seven long years of fighting to get Essure removed from the United States market has finally paid off," said Angie Firmalino, who formed a Facebook group in 2011 called Essure Problems and sparked a grass-roots movement of women advocating against the device.

The FDA estimates that Essure has been used by more than 750,000 patients worldwide since it was first approved by the agency on November 4, 2002. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.

From 2002 through 2017, the patient problems most frequently reported to the FDA were pain/abdominal pain (21,215), heavier menses/menstrual irregularities (9,846), headache (7,231), fatigue (5,842) and weight fluctuations (4,970).

Women who say they were harmed by Essure "have advocated for one another and on Capitol Hill to educate others about the safety of medical devices," said Madris Tomes, founder and CEO of Device Events. A self-described "data advocate," she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product.

"The women gave a voice to the data, and Bayer, at long last, heard what needed to be heard and did what needed to be done," Tomes said.

Dr. Christopher M. Zahn, vice president of the American College of Obstetricians and Gynecologists, said in a statement Friday that the safety data on hysteroscopic sterilization, the fallopian tube procedure by which Essure works, "has not changed."

Firmalino told CNN that Friday's announcement about Essure "has brought us all to our knees in gratitude, relief and celebration."

Women "will not be harmed by this device anymore," she said. "We have won. We have finally won."

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 471092

Reported Deaths: 9165
CountyCasesDeaths
Harrison32160471
Hinds30628574
DeSoto29693344
Jackson23098335
Rankin21062357
Lee14515218
Madison13993264
Jones13112218
Forrest12926231
Lauderdale11301294
Lowndes10206171
Lamar10017125
Pearl River8616208
Lafayette8052136
Hancock7172111
Washington6816146
Oktibbeha6799117
Neshoba6377201
Monroe6343158
Warren6310159
Pontotoc607692
Panola6056123
Bolivar5991143
Marshall5948116
Union562385
Pike5450133
Lincoln5217129
Alcorn516288
George456466
Scott450392
Leflore4392140
Prentiss435275
Itawamba433295
Tippah432480
Simpson4251110
Copiah424784
Wayne422363
Tate4202100
Adams4184110
Yazoo412486
Sunflower4077104
Covington406591
Marion4016100
Leake390485
Coahoma387098
Newton361674
Grenada3511100
Stone343757
Tishomingo323788
Attala319685
Jasper309562
Winston299191
Clay286172
Chickasaw280564
Clarke275587
Calhoun258539
Holmes258585
Smith242246
Yalobusha216447
Tallahatchie214949
Walthall204657
Lawrence203231
Greene202645
Perry195753
Webster191642
Amite191451
Noxubee174438
Montgomery169453
Jefferson Davis164341
Carroll159437
Tunica147634
Benton138232
Kemper136939
Claiborne125534
Choctaw124424
Humphreys123037
Franklin114327
Quitman101425
Wilkinson98435
Jefferson86332
Sharkey61720
Issaquena1916
Unassigned00

Alabama Coronavirus Cases

Cases: 761865

Reported Deaths: 12856
CountyCasesDeaths
Jefferson1087131712
Mobile696141168
Madison47959565
Baldwin35517431
Shelby34948283
Tuscaloosa32719498
Montgomery32358648
Lee21708200
Calhoun19823367
Morgan19140308
Etowah18450414
Marshall17138255
Houston15970340
St. Clair14803270
Limestone13986179
Elmore13893240
Cullman13892229
Lauderdale12986264
Talladega12235203
DeKalb11788220
Walker10110304
Autauga9416120
Blount9329149
Jackson9026132
Coffee8598153
Colbert8257160
Dale8204143
Escambia639399
Tallapoosa6315165
Covington6265153
Chilton6188128
Russell588353
Franklin560093
Chambers5182127
Dallas4595174
Marion4540114
Clarke447871
Pike441488
Geneva419499
Winston402682
Lawrence4018101
Bibb392976
Barbour335567
Marengo318878
Monroe308244
Butler307679
Pickens297366
Henry290752
Randolph290055
Hale284081
Cherokee277249
Fayette269769
Washington242244
Crenshaw229463
Clay220261
Macon212554
Cleburne207346
Lamar185538
Conecuh175237
Lowndes168156
Coosa161531
Wilcox153533
Bullock146242
Perry133132
Sumter122735
Greene118241
Choctaw71925
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