FDA to conduct public hearing on Essure birth control device

The device is inserted into the fallopian tubes, and after some time, tissue grows around it and blocks the way to prevent sperm cells from reaching the egg cell. He says they need to establishe what, if any relationship exists between the side effects patients are reporting and the device itself. and the problems relayed by some patients.

Users are also warned that the birth control implant may slip out of its position and enter the user’s pelvis or lower abdomen, following which a surgery might be needed for removing the device.

The U.S. Food and Drug Administration posted a review of 90 pages on Monday prior to a meeting on Thursday where experts are set to re-examine Essure’s safety and its effectiveness.

The company admits that risks are involved with every medical device and procedure, but the highest priority for Bayer is the safety of the patient. Some of these include heavy bleeding, pain, depression, hair loss and fatigue. Studies carried out by the manufacturing company as well as other researchers are suggesting that long-term issues such as chronic pain are extremely rare with the Essure birth control implant. At the hearing, a Bayer representative said the company will present the benefits of Essure, including that it is non-surgical, non-hormonal and may be available at no cost to those with health insurance.

In 2012 she had the device removed and underwent a hysterectomy. To date, almost 17,000 women in the United States who have had Essence implanted have complained that it has hurt them.

This complaints came up on social media, mostly on Twitter and Facebook in a group called “Essure Problems”, runned by Angela Lynch, who had issues in the recent past with Essure. “Significant limitations must be taken into account when reviewing the data” said the FDA to ABC News.

Veersema said a stronger screening process might be warranted to avoid implanting Essure in women who already have a uterine problem, such as fibroids.

“I felt like a shark was on the side of my body and wouldn’t let go”, she said.

In addition, Essure is an alloy of nickel-titanium that can also cause an allergic reaction, such as hives and itching in certain patients.