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FDA: Essure Birth Control Implant Safety To Be Reviewed

FDA: Estriol Essures Birth Control Implant Safety To Be Reviewed

The FDA is scheduled to review the Essure birth control implant for safety and potential health risks on Thursday.

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. (Photo : Twitter Photo Section)

The U.S. Food and Drug Administration announced Monday that it will review the Essure birth control implant for product safety and effectiveness. 

The FDA approved the implant in 2002, but because of recent complaints, the agency was compelled to conduct a review, which is scheduled for Thursday, ABC News reports.

According to the FDA, there had been a "dramatic increase" in the number of complaints regarding the birth control implant in the last two years. The agency was able to gather about 20,000 complaints about Essure's side effects through social media platforms. Most of these are from the Facebook group "Essure Problems," which has an estimated 17,000 members suffering from various side effects, Reuters reports.

"The FDA takes reports of safety concerns seriously," the agency said in a statement. "Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement."

Essure is a permanent birth control method wherein soft coils are inserted into the fallopian tubes to induce tissue to grow around them, thus blocking the sperm cells and preventing them from getting to the egg. The implant is meant to be permanent, according to the FDA.

Many complaints about Essure include side effects not identified by product manufacturer Bayer, such as heavy bleeding, chronic pain and fatigue.

One woman, 37-year-old Melanie Goshgarian, said when she had Essure implanted, she felt "a metal taste in her mouth" and she experienced heavy bleeding, according to ABC News.

"I felt like a shark was on the side of my body and wouldn't let go," she said. "My whole body started to change....I was itchy, my arms were tingling and my legs were tingling...I was confused all the time," Goshgarian said.

Another woman, 28-year-old Angela Lynch, said she initially dismissed the symptoms she felt as experiences related to her recent childbirth but later on realized they were not.

"Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust," Lynch said, according to Reuters. "After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting."

Lynch eventually had Essure removed and had a hysterectomy instead. She said she felt like she "woke up from a 5-year flu" when the birth control implant was taken out.

Bayer's medical director for Essure, Patricia Carney, said the company is open to hearing the discussion about the product's side effects.

"We want to understand as a company what is going on," Carney told Reuters. "We want to know whether there is a link to the product."

Tags: Progesterone, utrogestan, progesterone, hormones, estrogen, menopause symptoms, progesteron crème, progestin, hormone replacement therapy, pregnenolone, bioidentical hormones,  

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