--- title: Essure: FDA to Review Contraceptive Device Amid Complaints description: The FDA will convene a panel Thursday to review the Essure contraceptive device amid complaints that it causes harmful side effects. canonical: https://time.com/4048045/fda-review-essure-contraception/ author: Tessa Berenson article:opinion: false article:content_tier: free article:published_time: 2015-09-24T14:01:50.000Z article:modified_time: 2026-08-04T07:57:41.308Z article:section: Health og:title: FDA to Review Essure Contraceptive Device Amid Complaints og:description: Thousands of women have reported harmful side effects og:url: https://time.com/4048045/fda-review-essure-contraception/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt85db6b419ed6470a/698865318e0601b300462800/essure.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 1200 og:image:height: 675 og:image:alt: Essure og:type: article twitter:card: summary_large_image twitter:title: FDA to Review Essure Contraceptive Device Amid Complaints twitter:description: Thousands of women have reported harmful side effects twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt85db6b419ed6470a/698865318e0601b300462800/essure.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # FDA to Review Essure Contraceptive Device Amid Complaints > Sponsored content. 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Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-health-2026q3/newsletters?i=e4dcee07-e331-4d56-b5bd-cc51b08d4a91&cr=time-nl-health-2026q3-v1) ## Video: The Truth About Egg Freezing [Watch (HLS stream): The Truth About Egg Freezing](https://cdn.jwplayer.com/manifests/A1nDxOli.m3u8) (8:41)  _Published 2015-07-16. Vicki Rokhlin, 28, is relying on her 14 frozen eggs to have children. But will they work?_  by [Tessa Berenson](https://time.com/author/tessa-berenson/)  ## Tessa Berenson Sep 24, 2015 2:01 PM UTC  This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. AP  by [Tessa Berenson](https://time.com/author/tessa-berenson/)  ## Tessa Berenson Sep 24, 2015 2:01 PM UTC The Food and Drug Administration will convene a panel Thursday to review the Essure contraceptive device amid complaints that it causes harmful side effects. Essure is a permanent contraceptive device for women that is marketed as an alternative to tying the fallopian tubes, [NBC reports](http://www.nbcnews.com/health/womens-health/fda-reviews-essure-see-if-device-causes-problems-n432351). But of the roughly 750,000 women who have had Essure implanted, some 17,000 women say it harmed them, including by inducing chronic pain, bleeding, fatigue and skin allergies. An [FDA website page](http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm) about Essure said women had “\[described\] symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature.” Angela Lynch had Essure implanted when she was 28, and told NBC, “After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.” Once she had the device removed, “After three days it was like I woke up from a five-year flu.” Dr. Patricia Carney, Bayer AG’s medical director for Essure, said ,”We want to understand as a company what is going on. We want to know whether there is a link to the product.” Thursday’s panel will discuss potential changes to Essure’s label or whether more clinical studies should be conducted on the product, but the panel will not formally vote on any measures. The FDA approved Essure in 2002. ## Transcript I liken it to the feeling when my friends get engaged and they're so excited that they just solved this huge mystery in their life, and I'm happy for them. But, when I went through it and when I froze my eggs, I realized that I I've done this for myself. There was no man swooping in to fill in this puzzle piece. That was really empowering to know that I took fate into my own hands, and have changed the path of my life, because I wanted to, and I could. [ MUSIC ] I have a lot of these dreams that I wanna live out on my timeline. A lot of those dreams include long spans of international travel. I wanna write a novel. At one point, I'd love to be a TED talker. And so I was at my gynecologist office and she was so supportive when I was telling her about my dreams. And I was having a lot of anxiety How I was going to fulfill all these dreams before 32, 33, 34. And so we started talking about egg freezing. I kind of brought it up to her as a joke. And she said, you know, you should really think about this. And so she referred me to a doctor. We've seen a transformation in the type of patient who comes in for elective egg freezing. Six or seven years ago, it was often a woman who was experiencing concerns over her reproductive potential, Many of them already had diminished ovarian reserve. We could fast forward that today, where the woman are coming in. They're 35 years old, very frequently. The buzz is in the air at the company that Women her age, in her situation, are taking charge of their fertility, are coming in and freezing their eggs. So the culture has changed dramatically. [ MUSIC ] So I'll show you what we're basically trying to do is replace the water in the cell with a sugar- based cryoprotectant solution so that there are no ice crystals. Ice crystals cause damage to cell membranes [ BLANK_AUDIO ] Okay. Now I'm going to load the eggs onto the cryo device. All right, and then they get plunged into the liquid nitrogen. So this is the liquid nitrogen tank. [ BLANK_AUDIO ] This one here [ BLANK_AUDIO ] [ INAUDIBLE ] That's it. [ BLANK_AUDIO ] We've been fortunate enough to have dozens of women achieve a healthy pregnancy after using their thawed eggs. Recent reports in the literature suggests that over 10, 000 healthy babies have now been born from egg freezing technology. But some of those numbers that you just mentioned. Those are often just any births from a frozen egg. They don't necessarily distinguish between whether the egg was frozen by a donor or by a mother herself. Do you have any data about The number of babies that have been born from the mother's own frozen egg here at this clinic. [ BLANK_AUDIO ] So reports suggest that we've had over 10, 000 babies nationally and internationally from frozen eggs. But I know a lot of those babies aren't necessarily from women who have electively frozen their eggs for social reasons, many of them are from donor eggs. There is a difference from taking a 22 year old frozen egg and taking a 35 or 40 year old woman's egg. and someday thawing and fertilizing and transferring. So we have to be really careful about how we council patients. I know that many of the patients who freeze their eggs here are going to be able to someday have a healthy baby, but it won't be everybody. That's why it's not an insurance policy. It's just an opportunity to take some control over something we've really never had control of before. The truth about egg freezing is it's a relatively new procedure. It was just declassified as being experimental about a little over a year ago. So for that reason, there is not this large, comprehensive data pool of the number of eggs frozen, and then thawed, that have become babies. The vast majority of eggs that have been frozen have not been retrieved yet. So women have to understand that there are no numbers for them to call from when they are looking for will this work me. Because I'm 28 and my fertility is the best that it will ever get, I was able to do everything in one round. And I didn't understand the power of that until I woke up in the hospital right after surgery next to a 34 year old woman and she told me this was her third time trying this year, that's putting your body through three rounds of hormone injections, three surgeries And it's three times as expensive. And so the moment that really validated it for me was when this 34 year- old woman who had done 3 rounds in a year turned to me and said, wow. I wish someone had told me to do this at 28 cuz I would have. Some physicians and some marketing fertility arms do push women to freeze their eggs when they're at a very young age. Other clinics prefer that women wait until age 30 because what they've found is that the younger you are when you freeze, the less likely you are to need the eggs later on. However, as with most things in life, this is a double- edged sword. The younger you are, the better the quality of your eggs is going to be. Decreasing fertility starts during the time a woman is in her late puberty and goes throughout her life. Even when a woman is still getting her period in her late forties or even early fifties, it doesn't mean she's making normal eggs and that they're gonna be able to end up with healthy babies from that. It's not the success rate. It's the success rate for women like you. Are you 29? Are you 39? Are you 33? How are your tubes? Or do you have endometriosis? What's your hormonal health like? What's your body mass index? There are a huge number of varietal. That will determine conception success, whether it's natural or medically enhanced. Before I did all the research, I thought egg freezing was easy. And then I started reading blogs. And I started to get a sense of like whoa, your body goes through a lot. You're essentially forcing yourself to go into pregnancy mode in two weeks instead of nine months. I mean my estrogen shot up from 61 to 1900, I felt crazy. And I wasn't really prepared for that. Most of the women that have reached out to me The overall theme is, thank you for bringing awareness to the gravity of how much you put your body through, how much time this takes, how different your life is. Women shouldn't take this lightly, it's a big financial consideration, it's a big health consideration. It's a month of your life that you're sitting at home, you're not dating, you're not drinking, you're not smoking, you're not partying, you're not traveling. That was really hard for me Me. I mean I was up every morning at 7 AM to get an ultrasound, and a blood test. [ MUSIC ] I think there's no guarantee in life, right? No guarantee that I could have a child naturally, and there's no guarantee that one of these implanted embryos will stick. So, all that I can do is Is give my kids the best shot of a healthy future as possible. [ MUSIC ] Egg freezing is an amazing Oppurtunity but it is not. Absoutely not. An ironclad insurance policy. Know that going in. Hedging your bets is always a good idea in life. And you've got about $ 17000 in your back pocket that you're not gonna notice if it goes away Consider egg freezing. 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