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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: 159036

Reported Deaths: 3879
CountyCasesDeaths
DeSoto10563104
Hinds10414204
Harrison7397113
Jackson6655128
Rankin6057107
Lee540396
Madison5120107
Forrest394786
Jones376188
Lauderdale3663147
Lafayette341053
Washington3321108
Lamar301950
Oktibbeha255262
Lowndes252867
Bolivar248084
Panola237353
Neshoba2280122
Marshall225051
Leflore211191
Monroe209778
Pontotoc208131
Lincoln200566
Sunflower194155
Warren183058
Tate180451
Union172926
Copiah170840
Pike166760
Scott161330
Yazoo161340
Itawamba159936
Alcorn159328
Pearl River158969
Coahoma155943
Prentiss154931
Simpson154053
Adams147252
Grenada145445
Leake141844
Holmes134461
Covington130040
Tippah130030
George129525
Winston128726
Hancock127641
Wayne123024
Attala122834
Marion121447
Tishomingo114043
Chickasaw110732
Newton110529
Tallahatchie99427
Clay96127
Clarke94853
Jasper87023
Stone82015
Calhoun79513
Walthall79330
Montgomery78426
Carroll75515
Lawrence74614
Smith74216
Yalobusha74228
Noxubee73317
Perry68726
Tunica63019
Greene62422
Jefferson Davis59617
Claiborne59216
Amite57615
Humphreys55219
Quitman5107
Benton50418
Kemper48018
Webster47714
Wilkinson40722
Jefferson38312
Choctaw3637
Franklin3635
Sharkey32917
Issaquena1214
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Alabama Coronavirus Cases

Cases: 256828

Reported Deaths: 3711
CountyCasesDeaths
Jefferson34214511
Mobile20299366
Madison13925150
Tuscaloosa13591156
Montgomery12659238
Shelby1095877
Baldwin9163137
Lee792566
Morgan710851
Etowah677467
Calhoun6695121
Marshall665757
Houston548239
DeKalb504738
Cullman472043
St. Clair451857
Limestone447546
Lauderdale436054
Elmore427564
Walker3818111
Talladega374457
Jackson350723
Colbert336443
Blount310043
Autauga287342
Franklin259734
Coffee254115
Dale242054
Dallas232932
Chilton230841
Russell22813
Covington227934
Escambia206131
Tallapoosa189191
Chambers185950
Pike162214
Clarke161819
Marion146136
Winston141924
Lawrence135336
Pickens127720
Geneva12638
Marengo125224
Bibb123938
Barbour120629
Butler118842
Randolph105922
Cherokee105524
Hale99732
Fayette96316
Clay93525
Washington93319
Henry8946
Monroe83811
Lowndes82129
Cleburne79914
Macon76522
Crenshaw72930
Conecuh72414
Lamar7138
Bullock70919
Perry6927
Wilcox64918
Sumter58922
Greene44218
Choctaw43519
Coosa3724
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