Essure® Sterilization Coils: The Good, The Bad, and The Ugly

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Margaret Aranda, MD
The Essure ® Fallopian tube coils were manufactured by Conceptus, Inc. as a means for “permanent” birth control (click here for pictures). There was a need for something new and different that was a non-hormonal, non-invasive, and uncomplicated method of sterilization that did not require anesthesia. The surgical option, bilateral tubal ligation (BTL), had been introduced by Dr. Blundell in 1823 before the Medical Society of London, and while useful, was a drastic measure that many women were unwilling to take.

In the 1960’s, as the Women’s Liberation Movement first desired decreased numbers of children, and then no children at all, the need for permanent sterilization was rapidly evolving. Women were getting blood clots, weight gain and strokes from the pill. The IUD that released progesterone was falling out of favor.

The “T-shaped” Intrauterine Device (IUD) Mirena ® was approved by the FDA in 2000. In December 2009, The FDA sent a warning letter to Bayer, complaining that its campaign had “serious misrepresentations” of side effects including life-threatening ectopic pregnancies, uterine or intestinal perforations, internal scarring, serious infections, risk of pregnancy, organ damage, post-operative surgical complications, Streptococcal sepsis, intensive care unit stays, and more.

Enter Essure: The Solution for Permanent Birth Control

On November 4 2002, Bayer acquired the Essure coil product from Conceptus and its use was FDA approved through a “preemptive” process called “Expedited Review”. Expedited Review usually means that the product has already been in use (e.g., in another country).  The expedited review relies on data gathered from product use in other countries. The data presented to the FDA Panel are supposed to confirm the product’s use, safety, and effectiveness. We will see in subsequent posts that this was not the case for Essure. There were minimal data suggesting either the sufficient safety or efficacy to merit an expedited review.

The Good: How Essure was Supposed to Work

In an effort to offer a vaginal approach to permanent sterilization without hormone therapy or IUD complications, Essure was approved by the FDA in 2002.

Components of each tiny Essure coil include a spine of stainless steel, covered by 24 coils of expanding and elastic outer coil of nickel titanium. It is covered inside and out with polyethylene terephthalate (PET) fibers, that are wound in and around the inner coil of stainless steel. The specific goal of the Essure PET fibers is to cause inflammation, induce scar fibers, and thereby block fertilization of the egg with the sperm.

The proper placement of the Essure Fallopian tube coil is such that it is screwed into the tube from inside the uterus, in a counter – clockwise fashion with no screwdriver needed. To do this, a surgeon uses a surgical instrument by hysteroscopy so that the coil fills the fallopian tube, dangling into the uterus. Next an ‘ejector’ shoots the coil in a little further; a quick ‘tug’ is supposed to ‘prove’ that it is correctly placed and will not migrate.

A hysteroscope is too fat to fit past the cervical os, where the sperm travel up, often times the doctor cannot see the two holes where the Fallopian tubes empty into the uterus. So the doctor inserts the hysteroscope under IV sedation or local anesthesia block, to make the uterus numb. The doctor then tries to find two little holes, one on each side of the uterus, where the Fallopian tubes empty into the uterus.

Once the coil placements are confirmed, the procedure is complete. But this is just the beginning. The insides of Fallopian tubes still need to undergo a process fibrosis, a local inflammatory response around the coils, so the Fallopian tubes are blocked off, or occluded (See Illustration 3). The blockage needs to be double-confirmed, so a special procedure is done after three months.

The patient is instructed not to have unprotected sex for three months. Over these three months, an alternative form of birth control must be used.

At the end of the three-month period, a confirmation test must be done to show that the coils have done their job by fully occluding and blocking the Fallopian tubes. There is no other way to do this than to perform a  procedure called a hystero-salpingogram (HSG). The HSG uses dye injected past the vagina and cervix, past the uterus, and then hopefully it stops there, without going into the Fallopian tubes.

If the dye stays in the uterus and is blocked from going up both of the Fallopian tubes, the procedure is deemed a success and the patient is instructed that she can have unprotected sex now, because she can no longer have children.

If the contrast dye shows up inside the fallopian tube(s), however, then the patient can still get pregnant, and the coils have not finished doing their job at sclerosing the tubes shut. The doctor – patient relationship dictates what happens next; usually it is awaiting more time and then rechecking with another HSG at a later date. Although an area of controversy, removal of the coils is a possible choice.

The Bad: Side Effects of Essure

On the day of surgical placement, the most common side effects are: abdominal cramps, pain, and nausea/vomiting. Since the egg will still continue to be released each month at ovulation each month, the patient will still have her monthly period. The egg is simply reabsorbed into the body.

In 2013, Essure became a controversial procedure, with thousands of women complaining of complications leading to surgical removal, miscarriages with coils in babies’ ears, body hives, immune disease, coils breaking up into fragments, perforating the fallopian tubes, perforating the uterus, perforating the colon, pregnancies, severe abdominal bloating, pain on intercourse, general malaise, and even cancer. The first lawsuit against Bayer has been filed in 2014. Campaigner Erin Brockovich has taken Essure up as a cause, hosting her own website in the hopes of banning the product. Patients’ individual stories can be found here. Bayer continues to stand by its product, its safety, effectiveness, and reassures the public that it has a primary concern for public safety but that may not be enough.

If we look more closely at the Essure side effects, one thing becomes abundantly clear, they were predictable had anyone looked beyond the promise of ‘non-invasive’ sterilization. From the beginning, controlling the placement of the device within the Fallopian tubes was problematic and depended heavily on the surgical skill of the physician. Several studies indicate that correct placement occurred in only 84% to 98% of the cases. With perforation a likely outcome of a misplaced device, in a market of potentially millions of women, even a 2% failure rate is unacceptable. A 16% failure rate should give anyone pause; but it didn’t.

As difficult as that may be to accept, it seems that perforation may have been the least of the possible side effects. The chemical coating of the Essure device, meant by design to induce inflammation and scar tissue, was a toxicant itself; one that was inserted directly into the body.

The Ugly: Essure Chemical Coating

The Essure coils were coated in polyethylene terephthalate or PET fibers. PET fibers are plasticizers used in all sorts of commercial products. We recognize them by their brand names like Dacron (in the US), Terylene (in Briton) and Mylar under different conformational states. While these products are fantastic as outer coatings of materials to repel stains or water, as plasticizers that will degrade if exposed to heat and over time their usage in products that come in contact with food and/or are internalized is problematic to say the least.

The by-products of PET degradation, are acetaldehyde, a toxic intermediate in the metabolism of alcohol responsible for much of the liver disease in chronic alcoholics and antimony, a semi-metallic chemical element that is deleterious to health. Acetaldehyde is pervasive in airborne environments as a by-product wood smoke and other thermal reactions. Whether by inhalation or ingestion, acetyladehyde is a carcinogen. Should pregnancy occur in the presence of acetaldehyde exposure, it does cross the placenta and induce skeletal malformations, reduced birth weight, and increased postnatal mortality. Given its placement in the Fallopian tubes, follicular acetylaldehyde exposure could be predicted to induce changes in follicular morphology and perhaps even germ cell health for subsequent generations. Acetaldehyde is not something one wants leaching into the fallopian tubes, particularly when device placement is incorrect and pregnancy prevention nowhere near 100%.

Similarly problematic, Antimony leaching; antimony is a toxicant when applied topically. It induces local necrosis (cell damage and death). Systemically, continuous exposure to small amounts of antimony leads to an array of symptoms from cardiac to hepatic diseases similar to arsenic poisoning. Due to its very a very long half-life, antimony can induce reproductive disorders and chromosome damage. Antimony is toxic to reproduction with mutagenic and oncogenic potential.

Both degradation compounds have been found to leach into drinking water from plastic bottles exposed to heat (>65 degrees). Imagine how they might leach from a device placed into the Fallopian tubes where the temperature is ~98 degrees. There are no data regarding the degradation rate of the Essure coils or regarding the rate or risk of chemical exposure to women who used the device.  Even when the device is placed appropriately and skillfully, and sterilization reached, the potential local and systemic exposure to PET degradation products should give anyone pause, but it did not.

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55 Comments

  1. I had my Essure put in May 2015. I have 3 girls I and was really done having children since they were 22,19 and 6 at the time. This was the best method possible (I thought) My OBGYN Dr. recommended it and remind you I didn’t even look into this myself bad on my part for sure and I live with that regret daily. I just thought this is what my Dr’s says is good so just go with it. I feel as if my bones are deteriorating slowly after the coils have been put in. I’m in constant pain I can’t sleep at night. I never had issues like this. My left side has been killing me behind my ribs and lower back for almost 2 years already I’ve had CT scans doe MRI’s done and Dr’s cant’ find anything wrong. I’ve seen two OBGYN’s as well they keep saying it has nothing to do with the coils I BELIEVE different I know my body! I feel like my bones are holding up slowly and it pains me that I feel helpless in this situation and noting can be done!

  2. So many great comments and while I cannot answer specific medical issues, encouraging you to Join Groups – e-sisters on FB is what most people are doing. Wishing you all well and will be writing an update soon. And to let you know that it isn’t just Essure – I call it the Terrible Triad: Essure, power morcellator and vaginal mesh. Pass it along to sisters and cousins. We need to keep looking out for one another.

    Dr. Margaret Aranda
    The Rebel Patient book includes Essure.
    Of course.

  3. HAS ANYONE HAD THESE PROBLEMS AFTER ESSURE?
    *Essure then following till now.
    *Shingles in the mouth
    *Bacterial Stomach infect
    *Fissure/Fistula Surgery
    *Anual Spincher Surgery
    *Pacreasitis
    *pilonidal abscess rupture
    *2016- cystiscope procedure (now IC disease )
    *Bladder sling surgery
    *Nerology diseases
    *Obgyn appt scheduled due to pain, bleeding, and lump near pelvic area

    1. Lump on left side. Lipotripsy and stend in urethra multiple cysts on both ovaries. Pain during sexual intercourse. And rashes hives out of nowhere uexplained by primary care physician

  4. I had the essure put in in 2012 and have not gotten pregnant, however I have been diagnosed with diseases and conditions I shouldn’t even have at age 35. Just recently I was diagnosed with elevated d-dimer in my blood after an ER visited because I had trouble breathing and pain. i just want my life back. I have 3 kids that need me and my energy levels are horrible and I forget everything nowadays. I’m afraid of another surgery and complications afterward. If u are thinking of getting essure, DONT GET ESSURE, not worse the risk of your health & your family values. I joined the essure problems facebook page and soon when I’m ready I will share my story. The e-sisters in there are all very supportive and I’m so grateful for them.

  5. I have just recently 2 days ago had the essure procedure as advised by a gynaecology consultant, due to it being non evasive as we have 8 children and a busy home life as you can imagine with the youngest being only 9 months. I couldn’t find anything negative about essure when I put searches in Google so felt happy that I could be protected from pregnancy.

    2 days post op and I am starting to get worsening pelvic pain and fatigue. Not sure if I should wait for 3 month marker x ray test to see if coils are in place or go to doctors to get hysterectomy booked to save future pain. The procedure was only supposed to take 10 minutes but took over 45 minutes due to one Coil bending before placement and my fallopian tubes not opening properly any advice welcomed. I live in uk.

  6. I had the procedure many years ago and I have problems with numbness of hands, feet legs and arms, issues with colon,panic attacks, bloating,back pain. I have been to the neurologist, which he didn’t find anything wrong and doesn’t know why these symptoms exist. Frustrated from no answers from previous doctors I did my own investigation.

    1. I have almost every thing you just stated there’s times I can’t lift my arms or legs doc and ob has no answers never had problems before essure

  7. I am writing from Netherlands (Europe), had Essure placed 4 years ago and experience many problems e.g. Graves disease, hair loss, fatigue, brain fog, concentration loss, very heavy menstruation and had Novasure done etc. etc. I am seeing my gynecologist soon and want to have them removed . I am in shock that this was approved and I thought it was “safe and natural” without anesthetics placed

    1. I too was diagnosed with Graves disease almost exactly 1 year after essure placement. I was 43 and had never had any major medical diagnoses. I wonder how many others have had Graves disease after placement?

      1. Had essure put in 18 months ago. I was just told I have hyperthyroidism.
        I’m also very dizzy all the time. Have horrible pelvic pain, headaches and hot flashes

  8. I have had nothing but issues with Essure. I have had a number of Pelvic InflammatoryInfections my doctor has confirmed is due to the Essure Coils (mind you I never had one in my entire life until Essure) i constantly have excessive abdominal pain, two periods sometimes, fatigue, hot flashes, headaches, dissiness so many issues. I can’t even do sit ups or push ups without my body becoming enflamed. I absolutely hate them!

  9. I don’t really understand the logic of women who have had nothing but positive experinces with Essure (which is wonderful, of course). But how exactly does it help the majority, who are suffering?

    “One happy slave imprisons all the other slaves”.

    1. I don’t believe it is possible to have metal devices coated with synthetic chemicals designed to create mass inflammation implanted anywhere in one’s body and not suffer adverse side-effects. I further believe there are thousands of women, if not more, who are sick from Essure and have not not made the connection.

      1. I had the procedure done in 2001. Up until a year ago, I never thought I had any problems associated with of linked to essure until I saw a program on our local news programs. I also found support groups on Facebook. There was 4 pages of possible symptoms linked to the procedure. After printing it out and highlighting what I have going on, I was incredibly shocked

  10. Ive had my Essure for six years and have not had any issues…knock on wood. Its the best decision i have ever made. The only negative for me is the alternative birth control. I was placed on the depo shot and it was horrible…otherwise, i am quite satisfied with my decision..

    1. That’s great you have no issues and hope you don’t develop any. However some of the complaints are not anything you would even think to link to birth control. Essure problems.com as well as the Essure problems Facebook page will show you the problems and just how many women are suffering from the same one’s. Good luck and hope you stay healthy.

      1. I completely agree – I didn’t think I had any issues either until I looked at the side effects. I have 10+ side effects that have started since I got Essure about 5 years ago. Nothing major, but things I NEVER had problems with in the past. IB – check out the site that Sara left and if you have no issues… that is soooo WONDERFUL, but there are things on there that I though were me just getting older, and now I know things are not right.

  11. I had only one Essure implanted as the Dr couldn’t get the Essure into the second tube, (So I was half sterilized)I wish the Dr had of just taken it out at the time as there was no point in leaving it in. This was about 10years plus ago. I’ve had pains & then post menopausal bleeding & it seems that the wires have came dislodged & were actually coming out through my cervix, I didn’t think this could happen. I’ve had to have a hysteroscopy & removal as far as possible of the Essure But I was told the bit in my fallopian was well fibrosised & wouldn’t move & the only bit of wire left was cut really close to the tube. I wish I’d researched the device before I’d it implanted, I was having another procedure done & thought it seemed a good idea, No adverse affects were explained

    1. If I were you, I’d count my blessings that you’ve discovered this so soon after your procedure. I’d be running back to get them out asap before the scar tissue grows over.

  12. Can someone please answer a question for me about the pet fibers I had the hysterectomy to have the coils removed March 20th of 2015 I still suffer from several side effects that did not go away after the removal is there any way that the pet fibers could still be in my body or in my bloodstream how can I find this out is there a certain test that can be performed to find this out I am very concerned I don’t know if I am ruined for life if this is something I am going to have to deal with for the rest of my life my children need me and I cannot be myself because I don’t feel good everyday I am struggling with problems and everyday I am sick and this is after Essure removal so if someone could please give me more information on the pet fibers I would greatly appreciate it thank you in advance

    1. Hello Stephany,

      OMG I had mine removed 8 days after you but also have symptoms still. I want to find out if there is a test for the PET plastic in blood and if you can get it out. I had relief from my symptoms after and EDTA detox but the symptoms came back. Let me know if you have any new info.

      April

    2. I had my coils removed with my Fallopian tubes on November 18th 2015, after only having the coils for 21 days, and my symptoms have only gotten worse. I’m planning a hysterectomy within the month, but I can’t help but wonder if the debilitating symptoms I am experiencing is due to the PET fibers… My life has not been the same since October 26th, 2015. Everyday is a living hell. I hope and pray that removal of my uterus will give me some peace.

      1. So sorry to hear this. I had Essure placed in May 2009 and 4 months later started having symptoms of Type 1 Diabetes. In January 2010, I was diagnosed with Type 1 Diabetes. The inflammation of the Essure coils in my body I believe gave me this disease. I am trying to make the decision to have a complete hysterectomy so that all will be removed and possibly reverse my diabetes? Please let me know if anyone has had this complication.

      2. Hello my name is johana How did it go after hysterectomy im wondering. Cuz i planing to do the same this essure coils are hell nothing but problems did relief your symptoms? If so plz tell me i get uti so bad hot flashes ughh

  13. For anyone who has had the Essure coils, past or present, this is a wonderful source of information, support, and resources. These ladies are doing everything they can to see Essure pulled off the market. Facebook page- Essure Problems

  14. what a great article. If only the doctors had this much knowledge. I’m not sure anyone was thinking about the fibers before putting them in our bodies to cause constant inflammation. I feel blessed that my symptoms aren’t as bad as most. I had an eleven week long period, followed by heavy and long periods, pelvic pain, hair loss and bloating. I’m having a hysterectomy next month to get them out before I end up with Autoimmune issues from the inflammation. Thanks for wiring this and making others aware so they can make an informed choice.

    1. I was told that there were no chemicals or hormones in the essure. They were simply the coils themselves. This is truly alarming, especially after I was told I have high grade pre cancerous cell in my uterus. One of my coils has ruptured my uterus and is tangled. They now have to be removed. And maybe a hysterectomy.

  15. I had Essure implanted in 2004. I have been through hell ever since. I have debilitating fatigue, severe headaches daily, blood pressure issues, chest pain, extreme joint pain, tremors, tingling, digestive issues, severe bloating, neck and back pain, loss of motor skills in hands, loss of feeling in extremities when lying down, constipation, gas, diarrhea, food allergies I didn’t have before, a new allergy to Gluten, heart palpitations, stabbing pain in ovary/ fallopian tube area, heavy bleeding during periods, only 2 1/2 to 3 weeks in between periods, dizziness, “foggy” thinking, trouble concentrating, trouble deciphering words and sentences, unexplained sudden fevers, weakened immune system, all over body aches and pains, and a whole list of other issues. For those of us that cannot tolerate Essure, life is literally a living hell!!!!

    1. This is also how I have begun to feel. Does this mean we have an allergy to it’s materials? Have you had them removed? Just recently got diagnosed with an autoimmune disease (PSA) and I’m very miserable.

      1. Robin and Gina, Hello my name is Diane. I had a double knee replacement in 2013 and shortly after start experiencing systemic pain and fatigue. My whole life changed. My research lead me to a metal allergy. After many hurdles I found out through an LTT blood test that I was allergic to all the metals that were in my prosthesis. In 2014 I had two revision surgeries to remove the prosthesis that contained nickel and cobalt. I no longer have systemic pain or fatigue. My story was published by the Hospital for special Surgery in NYC. Many people from around the country have read my story online and have contacted me with similar symptoms. I believe there is a common link between the people suffering from essure coils and joint replacements which is the metals these devices are made out of. Our immune system rejects the metal therefore creating the similar side effects.

  16. I had essure done in 2004, I’ve never had problems cramps, pains and I pray I never do.. I feel bad for the woman that is going thorough so much.. May God bless you lady’s… over 10 years still no problems…

  17. I had the Essure device from 2009 till 2015. I still have problems.I lost my sense of smell almost completely. I have chronic arthritis/gout symptoms that travel to different joints in my body. I had a tubal ligation to remove them, but now I worry about the PET fibers and where they went. I have read that titanium and cadmium can cause arthritis symptoms and loss of smell. Thank you for printing this article to warn others of the toxicity of this product.

  18. I had this procedure done in 2008. By the sounds of things I am in the minority and have had no negative side effects at all.
    I am so sorry for all the women that age had such trouble.

  19. This is a huge, monstrosity of a problem for unwary women. But it is not the only one. Going in for a hysterectomy? Are they going to use a morcellator for that, to drill out scoops of uterus? Well come to find out that if you have uterine cancer in there, a HUGE injustice has just been done. The morcellator has increased you from Stage I (only in 1 place) to Stage 4 (all over the place) cancer; this is almost literally a death sentence. Hooman Noorchasm, MD PhD is fighting the morcellation battle because it happened to his Harvard MD, PhD wife! Cancer!

    Our biggest goal: To remove the FDA’s power to “fastly approve” medical devices through the process known as 501(c) Pre-emption. To get the root of the problem out of these scenarios for women, see: https://www.change.org/p/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy . As of Dec 3, there are 86,705 Supporters and 913,295 needed. Ladies, Speak Up!

  20. I had these coils implanted back in May of 2010! I was only 21 years young and trusted the doctor that recommended this procedure. I just turned 26 years young in October and now have to have a hysterectomy on December 29th at St . Francis hospital in Hartford Ct! I thought at 21 years old I didn’t want anymore children but never expected almost 5yrs later, I would have to undergo a hysterectomy due to the procedure. I’m not looking for any compensation, I am looking for Bayer and the FDA to take this product off of the market so, present and future women do not have to endure the constant pain that I go through on a daily basis!

  21. Excellent article. I had this procedure done in 2012. My doctor did not give me another choice. He told me that tubal ligation was medical malpractice and negligence. I should have run screaming but I trusted him. I had immediate pelvic pain and low back pain, breathing problems, heart palpitations, extreme anxiety, and severe fatigue. I found a doc through the University of Iowa and had them removed seven weeks later. My pain did not go away though, as I had only the coils and tubes removed. I have had countless health issues over the last two years to the point of round the clock narcotic pain meds. This has destroyed my vitality and my life. I am now learning that PET fibers can be left behind when they are removed in this manner and am now scheduled January 2 for a hysterectomy. My only hope is that I may be symptom free though who knows what future damage may be in store. This procedure is a disastrous failure. I whole-heartedly believe that with all of our voices, this device will soon be off the market and those of us that have been injured will be compensated for being guinea pigs.

    1. Hello Tisha,

      I wanted to know if you had the hysterectomy done and did it help you? I had the coils out also but still have symptoms also. Just want to know if it would help me too.

      April

  22. Thank you for this article specifically what the material that Essure is manufactured from and the PET fibers are doing to our bodies. One year post total hysto leaving ovaries and the internal inflammation is still a struggle. You learn to be your own physician and advocate as the time, money and energy explaining your story over and over again to doctors and specialists is overwhelming and disheartening. Essure does exactly what it was designed to do, but at a far more over all and debilitating manner than was ever publicized. My pathology stated chronic inflammation from an “unknown source” my organs were fused by adhesions and my uterus tested positive for nickle. As an educated and well informed woman I am disappointed that I chose this route as I may never know exactly what this device took from me long term. I can tell you that it’s still a struggle everyday.

  23. Essure is marketed as non surgical and non hormonal, that is why I fell for it. At the time I could not find any negative information on it. We need to be our own advocates and do our own research. Sadly we cannot trust the FDA, Bayer or even our doctors to guide us.

  24. Dear DS,
    Please excuse the delayed response due to my shoulder surgery (OUCH)…I knew it would hurt, but I didn’t know it would hurt THIS much. But it was a necessary evil.

    Yes, it seems that those whose purpose is to protect the public from harm, can jump through loopholes faster that a lion can run through a row of hula-hoops set on fire for a circus.

    I applaud you for your advocacy in sending women to the FDA For Consumers site, and congratulate you for becoming an Advocate. Help women. Inform them. Let them get this epiphany, and let us work together for all so that our daughters have better choices. We CAN make things better for our daughters.We WILL make things better for them. God is with us!

  25. Had mine removed four weeks ago, along with my entire uterus. Now that I’m telling people what I had put in me and the reason for my hysterectomy, they gape open-mouthed when I say “metal coils”. I SURE AS HECK wish I had had this exact response when I was first introduced to the idea.

    We are so quick to accept the magic pill. 🙁

    1. Would you be interested in writing and sharing your story on the blog? Personal stories are incredibly important.

  26. I urge every woman who has experienced side effects from Essure to file an adverse event report with the FDA. If enough adverse events are reported for a medical device or drug, the FDA is supposed to issue a warning or remove the product from the market. The form can be found here – http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm. Just click on the “new consumer-friendly form” link on that webpage and it will download a PDF form.

  27. Dr. Aranda,
    Thank you for this article. I have read of many problems with Essure. It is a shame that dangerous devices and drugs continue to be approved by the FDA. The medical pharmaceutical industry is constantly coming out with more and more products to increase profits when they have no benefits (and oftentimes have more risks) than older products. Although tubal ligation also has side effects, at least it does not involve a foreign object that can cause so many other problems. But of course, that means there are no revenues and profits for a medical device!

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