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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: 484675

Reported Deaths: 9480
CountyCasesDeaths
Harrison33151493
Hinds31184589
DeSoto30803365
Jackson23735349
Rankin21390373
Lee14963221
Madison14206272
Jones13430227
Forrest13199241
Lauderdale11623307
Lowndes10501176
Lamar10258130
Pearl River9151221
Lafayette8268137
Hancock7534113
Washington7144152
Oktibbeha6989124
Monroe6533167
Neshoba6489201
Warren6486166
Pontotoc632993
Panola6278127
Marshall6165126
Bolivar6129145
Union576089
Pike5626138
Alcorn540590
Lincoln5310132
George473572
Scott461596
Leflore4495140
Tippah448180
Prentiss447979
Itawamba4457100
Adams4429117
Tate4420103
Wayne434667
Simpson4339114
Copiah432988
Yazoo423686
Covington417192
Sunflower4155104
Marion4111104
Coahoma3986100
Leake398286
Newton372375
Grenada3565104
Stone351360
Tishomingo338389
Attala325987
Jasper316062
Winston305691
Clay297374
Chickasaw287866
Clarke283290
Calhoun267741
Holmes262887
Smith252249
Yalobusha224347
Tallahatchie221150
Walthall211758
Greene209945
Lawrence207034
Perry201054
Amite199452
Webster196942
Noxubee179339
Montgomery172954
Jefferson Davis168342
Carroll162537
Tunica154235
Benton143035
Kemper138840
Choctaw128826
Claiborne127134
Humphreys127038
Franklin116928
Quitman104227
Wilkinson102036
Jefferson91533
Sharkey63020
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 790648

Reported Deaths: 14025
CountyCasesDeaths
Jefferson1117431765
Mobile709021237
Madison50032633
Shelby36350315
Baldwin36278495
Tuscaloosa34034548
Montgomery33229678
Lee22712220
Calhoun21297410
Morgan19852335
Etowah19341462
Marshall17716274
Houston16862386
St. Clair15479305
Cullman14659258
Limestone14609188
Elmore14507264
Lauderdale13557281
Talladega13015236
DeKalb12214237
Walker10604330
Blount9735157
Autauga9691137
Jackson9400158
Coffee8934175
Dale8631173
Colbert8545184
Tallapoosa6688181
Escambia6599121
Covington6466167
Chilton6395144
Russell608755
Franklin5805101
Chambers5425134
Marion4818120
Dallas4713189
Clarke464079
Pike463297
Geneva4433117
Winston427395
Lawrence4124108
Bibb410281
Barbour347470
Marengo326485
Monroe320253
Butler318490
Randolph306656
Pickens306474
Henry302658
Hale293085
Cherokee290855
Fayette280373
Washington245548
Crenshaw238770
Cleburne236751
Clay229265
Macon220658
Lamar200443
Conecuh182046
Coosa170835
Lowndes170858
Wilcox159736
Bullock149543
Perry136537
Sumter124736
Greene121443
Choctaw73427
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