FDA tightens restrictions on Essure birth control device

Since it was approved to go on the market in 2002, Essure, an implantable permanent contraceptive device, has been pl...

Posted: Apr 10, 2018 9:06 AM
Updated: Apr 10, 2018 9:06 AM

Since it was approved to go on the market in 2002, Essure, an implantable permanent contraceptive device, has been plagued by controversy. Thousands of women have filed grievances with the US Food and Drug Administration about unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding.

In its latest response to ongoing concerns, the FDA issued an order Monday to restrict sales and distribution of the device.

The only implantable permanent women's contraceptive, Essure, faces new restrictions

The FDA is responding to complaints from women about the device

"We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option," FDA Commissioner Dr. Scott Gottlieb said in a written statement.

"Despite previous efforts to alert women to the potential complications of Essure," he continued, "we know that some patients still aren't receiving this important information. That is simply unacceptable."

Essure is the only non-surgical permanent form of birth control for women on the market in the US. A health care provider inserts the flexible coils of the device into the fallopian tubes by going through a woman's vagina and cervix. When it works as intended, scar tissue forms around the device over the course of about three months and builds a barrier to block sperm from reaching -- and fertilizing -- a woman's eggs.

Between November 2002 and May 2015, more than 5,000 complaints about the device were registered, prompting the FDA to order manufacturer Bayer to complete a post-market study, including effectiveness and adverse events. The agency also required Bayer to add a black box warning label to the product, to call attention to the risks. Sales of Essure fell in the US by about 70%, the FDA reports.

Bayer said in a statement Monday that "The benefit/risk profile of Essure has not changed and remains positive."

But, the pharmaceutical company added, "Patients deserve the most accurate and comprehensive information to help make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasize this point."

The company touted its commitment to "Providing women with safe and effective healthcare options that meet their individual needs."

The online support group Essure Problems, which has more than 36,000 members, said in a statement Monday that it reported to the FDA commissioner that 95% of women implanted with the device after the FDA's previous guidance still weren't getting warnings about Essure.

Last year, nearly 12,000 "adverse event reports" were submitted, including stories of device removals that required hysterectomies, said Madris Tomes, founder and CEO of Device Events, which seeks to bolster patient safety by sharing information about negative reactions to medical devices.

The FDA outlined in its Monday release how some patients experienced "perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain" and more.

Bayer mentioned in a recent financial report that as of January 30, more than 16,000 Essure users had filed lawsuits against the company, alleging outcomes that included hysterectomies, perforations, depression and weight gain.

The new legally required labeling on Essure will permit the sale and distribution of the cotraceptive device only to facilities and health care providers that review, complete and sign with patients a brochure entitled a "Patient-Doctor Discussion Checklist -- Acceptance of Risk and Informed Decision Acknowledgement."

It is on Bayer to implement these restrictions, the FDA reports. Failure to comply will result in FDA action "including applicable criminal and civil penalties."

It was welcome news to the Essure Problems community, though its members still would prefer that the device be taken off the market.

"While it doesn't take Essure off the shelves, it certainly holds Bayer accountable," the group said in its statement.

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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