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.

Minnesota Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 24190

Reported Deaths: 1036
CountyConfirmedDeaths
Hennepin8181606
Ramsey2863122
Stearns201413
Nobles15125
Anoka136370
Dakota126354
Washington61731
Olmsted60810
Kandiyohi4901
Rice4522
Clay42426
Scott4082
Todd3130
Wright3051
Mower3031
Sherburne2372
Carver2062
Benton1753
Steele1590
Blue Earth1380
Martin1295
St. Louis11814
Freeborn1150
Pine890
Nicollet8610
Unassigned8610
Winona7915
Carlton730
Watonwan710
Cottonwood700
Crow Wing682
Goodhue663
Otter Tail640
Chisago611
Polk612
Itasca5410
Dodge520
Chippewa491
Lyon490
Morrison450
Meeker450
Le Sueur441
Douglas410
Becker390
Jackson390
Murray390
McLeod340
Isanti320
Waseca260
Rock220
Mille Lacs191
Faribault180
Swift180
Wabasha180
Fillmore171
Pennington170
Sibley160
Brown152
Beltrami140
Cass132
Norman130
Pipestone120
Kanabec111
Wilkin113
Marshall100
Pope90
Wadena90
Aitkin80
Koochiching70
Yellow Medicine60
Mahnomen61
Lincoln50
Renville50
Big Stone40
Grant40
Red Lake40
Redwood40
Clearwater30
Hubbard30
Traverse30
Lac qui Parle30
Roseau30
Houston20
Lake10
Kittson10
Stevens10

Iowa Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 19217

Reported Deaths: 531
CountyConfirmedDeaths
Polk4160125
Woodbury274034
Black Hawk173944
Linn94976
Dallas89220
Marshall89216
Buena Vista7350
Johnson6149
Wapello5589
Muscatine55641
Crawford5142
Tama40227
Scott35810
Dubuque34518
Louisa34311
Jasper26116
Pottawattamie2578
Sioux2190
Washington1888
Wright1670
Plymouth1292
Warren1260
Allamakee1204
Story1091
Mahaska9310
Poweshiek908
Henry711
Bremer696
Des Moines621
Clinton611
Boone610
Taylor540
Clarke530
Guthrie503
Cedar461
Benton411
Webster391
Monroe385
Shelby370
Jones360
Hamilton350
Clayton343
Iowa330
Buchanan330
Osceola330
Marion320
Cerro Gordo281
Cherokee280
Madison282
Fayette270
Lee250
Winneshiek240
Monona240
Jefferson230
Harrison220
Davis210
Lyon210
Dickinson200
Grundy200
Mills190
Floyd191
Sac180
Humboldt170
Lucas170
Hardin160
Hancock160
Delaware150
Keokuk150
Clay150
Appanoose153
Butler151
Emmet140
Ida140
Page130
Greene130
Franklin130
Cass120
Howard120
Audubon121
Jackson120
Winnebago110
Pocahontas110
Chickasaw100
Carroll90
Van Buren90
Adair90
Kossuth90
Union70
Adams70
Montgomery70
Palo Alto60
Unassigned60
Fremont40
Mitchell40
Ringgold40
Worth30
Calhoun20
Wayne10
Decatur10
Rochester
Clear
67° wxIcon
Hi: 72° Lo: 60°
Feels Like: 67°
Mason City
Scattered Clouds
71° wxIcon
Hi: 73° Lo: 60°
Feels Like: 71°
Albert Lea
Clear
70° wxIcon
Hi: 73° Lo: 61°
Feels Like: 70°
Austin
Clear
72° wxIcon
Hi: 75° Lo: 62°
Feels Like: 72°
Charles City
Clear
70° wxIcon
Hi: 74° Lo: 60°
Feels Like: 70°
Sunnier skies for the weekend
KIMT Radar
KIMT Eye in the sky

Latest Video

Image

Rochester People's Rally

Image

Religious leaders call for justice for George Floyd

Image

Rochester downtown under curfew Saturday night

Image

Sean Weather 5/30

Image

Governor Walz GivesUpdate

Image

Gov. Walz Addresses Minnesotans in Overnight Press Conference

Image

Riots, Fires continue in Minneapolis

Image

Protesters in Downtown Rochester

Image

Mower County Fair will go on as planned

Image

Minneapolis Gas Stations Shut Down

Community Events