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: 319704

Reported Deaths: 7369
CountyCasesDeaths
DeSoto22276267
Hinds20677421
Harrison18407317
Rankin13880282
Jackson13689248
Madison10249224
Lee10056176
Jones8464167
Forrest7827153
Lauderdale7260242
Lowndes6509150
Lamar634888
Lafayette6310121
Washington5420137
Bolivar4837133
Panola4669110
Oktibbeha466098
Pearl River4604147
Marshall4573105
Warren4440121
Pontotoc425373
Union415777
Monroe4155135
Neshoba4061179
Lincoln4008112
Hancock386687
Leflore3515125
Tate342486
Sunflower339491
Pike3369111
Alcorn325972
Scott320174
Yazoo314171
Adams307486
Itawamba305178
Copiah299966
Coahoma298784
Simpson298189
Tippah291968
Prentiss283861
Leake271974
Marion271280
Covington267283
Wayne264442
Grenada264087
George252051
Newton248663
Tishomingo231568
Winston229981
Jasper222148
Attala215073
Chickasaw210559
Holmes190374
Clay187854
Stone187833
Tallahatchie180041
Clarke178980
Calhoun174132
Yalobusha167840
Smith164034
Walthall135347
Greene131833
Lawrence131024
Montgomery128643
Noxubee128034
Perry127138
Amite126342
Carroll122330
Webster115032
Jefferson Davis108033
Tunica108027
Claiborne103130
Benton102325
Humphreys97533
Kemper96629
Franklin85023
Quitman82216
Choctaw79118
Wilkinson69532
Jefferson66228
Sharkey50917
Issaquena1696
Unassigned00

Alabama Coronavirus Cases

Cases: 548323

Reported Deaths: 11288
CountyCasesDeaths
Jefferson809531565
Mobile42066826
Madison35663525
Tuscaloosa26162458
Shelby25595254
Montgomery25081612
Baldwin21839313
Lee16265176
Calhoun14718325
Morgan14626285
Etowah14171363
Marshall12449230
Houston10764288
Elmore10295213
Limestone10182157
St. Clair10160251
Cullman9941201
Lauderdale9596249
DeKalb8967189
Talladega8458184
Walker7335280
Autauga7230113
Blount6944139
Jackson6922113
Colbert6414140
Coffee5627127
Dale4929114
Russell454941
Chilton4472116
Franklin431083
Covington4273122
Tallapoosa4136155
Escambia401780
Chambers3726124
Dallas3607156
Clarke352961
Marion3242106
Pike314078
Lawrence3129100
Winston283572
Bibb268464
Geneva257581
Marengo250665
Pickens236862
Barbour234659
Hale226878
Butler224071
Fayette218162
Henry193843
Cherokee187245
Randolph187044
Monroe179341
Washington170439
Macon162951
Clay160159
Crenshaw155657
Cleburne153244
Lamar146537
Lowndes142054
Wilcox127030
Bullock124242
Conecuh113430
Coosa111429
Perry108626
Sumter105732
Greene93534
Choctaw62025
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