New measure would block Essure device for women

WASHINGTON (MEDIA GENERAL) – After suffering symptoms of extreme pelvic pain, bleeding and migraines, former users of a birth control device known as Essure are pushing for Congress to immediately stop the sale of the device nationwide.

On Wednesday, Congressman Mike Fitzpatrick (R-PA) introduced the measure known as the “E-Free Act” which would remove Essure from the market and encourage the Food and Drug Administration to re-examine its approval of the product first launched in 2002.

Essure, produced by a branch of Bayer Pharmaceuticals, markets the product as the “only permanent birth control with a nonsurgical procedure.”

Since it’s launch, the company has fought back against accusations of complications from women who’ve complained of severe problems from the procedure.

“The failures of Essure are well documented and wide ranging. Yet, in the face of all these facts, this device remains on the market; certified with the FDA’s stamp of approval,” Rep. Fitzpatrick said outside the Capitol on Wednesday.

Surrounded by several former Essure customers, Fitzpatrick demanded more research into the product in an effort to protect consumers nationwide.

‘With these side effects, I couldn’t be the woman I used to be’

Essure patient
Former Essure patient pleads with lawmakers to review the FDA approval of the device labeled as a “non-surgical” form of permanent birth control. (Media General/Mark Meredith)

After suffering similar symptoms of pain, loss of hair and severe bleeding, former Essure patients began communicating through a Facebook group to launch a national campaign to pull Essure off the market.

“After finding the page, new members are always shocked to see how many women are experiencing the same problems,” said Amanda Rusmisell, a former Essure user and a member of the Essure Problems Group.

FDA: ‘We’ll continue to monitor the safety of Essure…’

The Food and Drug Administration, which is responsible for approving medical devices like Essure, has said its reviewed Essure both before and after allowing the product on the market.

In a statement released in September, the FDA said it believed Essure provided little to no complications for patients in the long term after looking at the product for consumers five years after implementation.

“To date, we have found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement,” the statement read.

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