FDA orders studies on birth control device as Essure complaints grow in CNY

Some women calling for device to be banned, FDA calls for more warning labels

SYRACUSE (WSYR-TV) - Complaints about a permanent birth control device led the U.S. Food and Drug Administration to issue an order to the drug's maker, Bayer, calling for new studies about Essure.

The agency also wants more warnings on the label and a patient checklist to make sure women understand the risks.

The response follows a hearing last year, when the Obstetrics and Gynecology Devices Panel listened to patients who said they had serious problems with Essure.

The procedure involves placing tiny coils, containing a nickel-titanium alloy, into the fallopian tubes.

Syracuse-based doctor Myron Luthringer says the procedure creates an inflammatory response, so scar tissue surrounds the coil with the intention of permanently blocking pregnancy.

"I've seen patients that have coils that have migrated, fragmented, attached to the bowel, perforated through the uterus, perforated through the fallopian tubes causing pain to other organs," Dr. Luthringer said.

He estimates he's performed hysterectomies to remove the device for more than one hundred women from across Central New York. 

Online, Essure advertises a quick recovery — with most women going home in 45 minutes and resuming normal activities in a day or two.

Several women in Central New York contacted NewsChannel 9, insisting they experienced long-term pain.

"It increasingly gets worse and worse. It varies from cramping to stabbing," said Casey Downes of Homer.

Sheila Pitt of Chittenango compared the feeling to a sharp poking.

"The lower back pain that never ever went away and then the inflammation started and my whole body swelled," recalled Danielle Durant of Camden.

They call themselves E-sisters — a network of women, sharing their Essure stories.

"Both were perforated through my fallopian tubes, sticking straight out. So, every time ovulation occurred, I would have excruciating pain on top of the numbness," said Paula Lehtonen of Mexico.

Some of the women say symptoms began immediately when the coils were placed. Others say they noticed health issues months later, until the coils were removed.

"Probably 90 percent of my symptoms were gone as soon as I woke up from surgery," Durant added.

A statement from a Bayer spokesperson says the company will work with the FDA.

"Patient safety and appropriate use of Essure are our greatest priorities," stated Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer. "A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."

The company also posted a video statement on Youtube in late February. Click here to watch.

Pitt was among the women who shared her story with the FDA panel during the hearing last year. The results leave her with mixed emotions.

"It is definitely a step in the right direction for people who are considering Essure to be able to have the black box warning and the checklist that they are proposing. It fails to help the people who currently have Essure," Pitt said.

She has an attorney, but since the device was approved by the FDA more than a decade ago — she's been told the manufacturer may be legally protected.

Many of her E-sisters want that approval reversed.

"I'm angry," Lehtonen said. "I'm so mad that I'm not going to stop until this is taken off the market. I think somebody should be held accountable."

The women are part of a growing movement online, where Facebook pages have become a dedicated meeting ground for patients who said they didn't realize why they were in pain until they heard others share their stories.

"They are not taking us seriously. But, that's okay because we are not going away," Durant added


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