Articles on Essure that have appeared in the AWHC Newsletter (in date order).
Over the past ten years another insidious experiment has been under-taken on women by obstetrician/ gynaecologists keen to be seen to offering women a new form of permanent contraception. Like many other medical devices it was released onto the market by the US Food & Drug Administration (FDA) without any decent sized long-term trials or adequate reporting of all the data. So it was utterly predictable that women began reporting severe problems with the device soon after it came onto the market.
Essure, a form of female sterilisation, was originally developed and manufactured by Conceptus which was then bought out by Bayer Pharmaceuticals. Essure is a thoroughly nasty piece of work. It consists of two micro-coils that are inserted into each fallopian tube. The coils are made up of a stainless steel inner coil, a nickel titanium (nitinol) expanding, super elastic outer coil, and polyethylene fibres or strings. The fibres are wound in and around the inner coil and are there for the purpose of creating irritation and inflammation which causes scar tissue to grow over the coils, blocking the tubes.
The “advantage” of Essure over the other form of female sterilisation – tubal ligation – is that the device does not contain any hormones, and it does not require surgery. It was developed to be inserted in an office setting by health professionals trained in the method of inserting this device. As it takes several months for the scar tissue to completely block off the fallopian tubes, the woman needs to use another form of contraception for the first three months. An x-ray, called a hysterosalpingography, is then done to confirm that the fallopian tubes are blocked. Sometimes an ultrasound scan is used instead.
Side effects of inserting the device
Women report experiencing a number of unpleasant side effects of the “hysteroscopic placement procedure.” These include cramping, nausea and vomiting, dizziness or light headedness, mild to moderate pain during and immediately after the procedure, and bleeding.
The ongoing risk of the harms caused by this device are many and include chronic inflammation, fibrosis, severe pelvic pain, perforation of the uterus or fallopian tubes, infections, and tubal blockage occurring on only one side. It is also not a good idea if you are allergic to nickel.
The Mayo Clinic website also states: “You may not be able to have some electropelvic procedures, such as some types of endometrial ablation, after having the Essure system implanted. This is because Essure inserts are metallic and can conduct electricity, possibly resulting in tissue damage.”1
There are also risks associated with the surgery needed to reverse the Essure procedure. Like the gynaecological mesh, Essure is not designed to be removed and problems can arise as a result of the surgery under-taken to remove the coils. Hundreds of women have had to have a hysterectomy in order to remove pieces of the device.
As if the side effects listed above weren’t enough to cause a woman to think twice about using this form of sterilisation, there is one more thing. The FDA’s 2002 briefing document “Essure: Instructions for use” contains the following statement – in bold type: “There is the potential that unknown risks exist.”2
The 304-page transcript of the FDA’s meeting at which approval was given to market the contraceptive device also makes for interesting and disturbing reading. It reveals just how closely the FDA works with the pharmaceutical industry during the process of designing and undertaking trials, with the result that meetings such as these are a mere formality as far as the FDA’s granting of approval for such a device with no strings attached (no pun intended).3
Issues were raised by some members of the FDA panel who expressed concerns about the small numbers of women in the phase two and phase three trials of the device, the age and ethnicity of the women when compared to the data on women who had a tubal ligation, the lack of long-term data for Essure, the use of ultrasound scans instead of x-rays to check if the fallopian tubes are completely blocked, how the device will be marketed and what women will be told. However these concerns were quickly smoothed over and dispensed with.
In 2002 the FDA approved Essure for use as a class 3 medical device which was the first time any contraception had received such a classification. The FDA also made it impossible for women to sue the company for damage.
Women in America have now turned to social media to voice their complaints about Essure.4 There is now a Facebook group page for women who have experienced problems with the device. It has got so bad that even Erin Brockovich recently got involved. She has established a website for women with the aim of creating “a movement to get this product off the market and find a remedy for those who have been harmed.”5 She has already heard from over 1,000 women.
What really frustrates Erin Brockovich is the fact that when the FDA approved Essure it gave it what is known as pre-emption status, meaning that women who have suffered as a result of Essure can’t sue the company that makes it.
“This is a law that will protect the company and if the product’s defective, the people who’ve been harmed by it basically have no recourse. That’s not fair,” Erin told NewsChannel 5 Investigates.6
What about New Zealand women?
There is no protection for New Zealanders who find themselves damaged and their lives turned upside down as a result of medical devices, such as metal-on-metal hip joint replacements, gynaecological and other sorts of mesh, and silicone breast implants, to name just a few.
There is Medsafe – the NZ Medicines and Medical Devices Safety Authority. “We are responsible for the regulation of medicines and medical devices in New Zealand. We ensure that medicines and medical devices are acceptably safe,” is the proclamation on their website.7 Unfortunately, Medsafe relies on the FDA and the European Medicines Agency for their information on whether drugs and medical devices are “acceptably safe.” Given what we now know about how closely the FDA works with the pharmaceutical industry – to the point of working for the industry rather than for the protection of the general public8, this leaves the New Zealand public very vulnerable.
In 2011 the FDA allowed Conceptus to remove a contraindication on Essure’s official packaging for women with a known hypersensitivity to nickel, as well as a recommendation that women undergo a skin test to see if they have an unknown nickel allergy. Profits before public safety is also the main driver in the FDA.
Although all medical devices must be notified to Medsafe’s Web Assisted Notification of Devices (WAND) database in order to be legally supplied in New Zealand, this is not an approval system. As we saw during the silicone breast implant saga this did not prevent health professionals importing and implanting cheap medical devices under the radar in the past. The sponsor, the person or organisation that imports a device, is required to notify the device to the WAND database within 30 days of becoming the sponsor of the device. There are no fees involved in a device being on WAND. However only the sponsors have access to this database; there is no public access to this information.
Essure is being used in NZ
The AWHC is aware that women in the Auckland, MidCentral and Bay of Plenty DHBs are having this device implanted. Some doctors seem to think that Essure is superior to a tubal ligation, and at Tauranga hospital are even inserting them under a general anaesthetic. So much for a quick insertion in the doctor’s surgery! These same health professionals also have no problems using scarce radiology resources when checking to see if the coils/fibres have done their job and the resulting inflammation has completely blocked the fallopian tubes. Even more important is the information women are getting prior to agreeing to try this method of contraception. Are they tested for an allergy to nickel? Do they really understand how the device works, that the inflammation caused by Essure may cause severe pain, and that removal of the device is problematic and may cause immense damage to their reproductive system?
At some stage the Accident Compensation Corporation (ACC) will become involved when women who have been damaged by Essure begin applying for compensation for the damage to their bodies and lives that this device has caused. It is unlikely that ACC will be very receptive if past experience with medical devices are anything to go by.
Taking a complaint to the Health and Disability Commissioner isn’t likely to be successful either as the current Commissioner has already refused requests to investigate other medical devices such as metal-on-metal hip joint replacements, silicone breast implants, and gynaecological mesh.
While PHARMAC has now been given responsibility for overseeing the purchase of medical devices as well as drugs, it is going to be too late to prevent the damage that this particular contraceptive device will have caused goodness knows how many women in New Zealand.
The message here is that women are much safer having a tubal ligation.
2. Essure Permanent Birth Control System: Instructions for use at http://www.fda.gov/ohrms/dockets/ac/02/briefing/3881b1_03.pdf (page 6).
3. Food and Drug Administration, Center For Devices and Radiological Health, Obstetrics and Gynecology Devices Panel at http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3881t1.doc
4. Gonzalez, D, 2012: Women Take to Social Media to Complain About Essure, NBC Miami.
6. http://www.newschannel5.com/story/22924769/women-report-painful-side-effects-from-birth-control (no longer available online)
8. Peter Gotzsche “Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare.” Radcliffe Publishing 2013.
The AWHC wrote to both Medsafe and the Minister of Health about our concerns over the use of the contraceptive device Essure, after researching and writing the article that appeared in the October issue of the AWHC newsletter. We sent a copy of the newsletter with each letter. In our letter to Medsafe we asked them to place a warning on their website about this device.
Update on Essure
No action from Medsafe
Medsafe has responded to our letter, and predictably the letter states that Medsafe does not plan to take any action as “there have been no reports of adverse events or complaints relating to the use of this product.” Translation: we need some New Zealand victims to make a complaint before we are willing to do anything. If past experience is anything to go by, even then Medsafe is unlikely to do anything.
Chris James, Acting Group Manager of Medsafe acknowledges that the US Food and Drug Administration (FDA) has recently released safety information relating to Essure on its website,1 but goes on to say “at the present time there is insufficient evidence to justify further investigation of this issue or the publication of safety information on the Medsafe website.” Translation: if the FDA, whose by-line is “Promoting and Protecting Your Health”, doesn’t think there is anything to worry about then neither do we.
The FDA claims it has conducted a thorough review of the available information about Essure since they approved it in 2002. The FDA states it has received 943 reports of adverse events related to Essure. The most frequently reported problems were pain (606), haemorrhage (140), headache (130), menstrual irregularities (95), fatigue (88), and weight fluctuations (77). Some of the device problems reported were migration of the device or device component (116), patient device incompatibility, e.g. allergy to nickel (113), device operating differently than expected (73), malposition of the device (46), and device breakage (37).
While some of these problems “are known through clinical studies” and included in the Essure product information, extreme fatigue, depression and weight gain “were not observed in post-approval studies, or described in the clinical literature.”
No action from the FDA
The problem with this is that we have to take the FDA’s word that there were post-approval studies, and that the clinical literature wasn’t just more bullshit produced by Conceptus, the company that manufactured this device. Conceptus conducted its own 5-year study which simply cannot be relied on to report the truth about its one and only product. It is also extremely convenient that Conceptus was “acquired” by Bayer on 5 June 2013 – shortly before the problems women were experiencing with device began to surface in the media.
“Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known,” the FDA disingenuously maintains.1
It is well known internationally that the FDA lost its credibility years ago. As noted in last month’s newsletter article, in 2011 the FDA allowed Conceptus to remove a contraindication on Essure’s official packaging for women with a known hypersensitivity to nickel, as well as a recommenda-tion that women undergo a skin test to see if they have an unknown nickel allergy.
Peter Gotzsche in his book “Deadly Medicines and Organised Crime” describes in depth how corrupt the FDA has become. “The FDA, by spinelessly knuckling under to every whim of the drug companies, has thrown away its high reputation, and in so doing, forfeited our trust,” he concludes after describing numerous instances of corruption within the upper echelons of the FDA.2 That Medsafe is still expecting the New Zealand public to trust the FDA’s judgement and advice is therefore extremely worrying.
Over the past month the AWHC has become aware that the Auckland DHB is also involved in providing women in Auckland with this form of contraception and has been using an operating theatre to insert this device, although this is about to change.3
The AWHC is concerned about the information women are getting prior to agreeing to this method of contraception. Do they understand how the device works and that it may take more than three months for the scar tissue to completely block the fallopian tubes necessitating the need for several scans before they can be assured that they are completely sterilised? Do they know that removal of the device is problematic and may cause immense damage to their reproductive system?
Meanwhile back in the USA, Mitchell Creinin, Professor & Chair of Obstetrics and Gynecology at the University of California, Davis published a study in 2011 comparing the reliability of sterilisation with Essure compared with tubal ligation at one year. He found that “the efficacy of hystero-scopic sterilisation (Essure) is inferior at a population level.”4
This is because a successful Essure procedure requires all of these steps:
- Visualisation of both tubal ostia on hysteroscopy.
- Successful placement of the microinserts in the correct position.
- Hysterosalpingogaphy at least three months later with the use of an alternate form of contraception in the interim.
- Demonstrated tubal occlusion by the Essure devices.
In 2002 Conceptus pulled out all stops to convince the FDA panel that Essure was a superior, more reliable method of permanent contraception than tubal ligation. An independent study has now shown that it is not.
1. FDA Website: Essure Permanent Birth Control
2. Peter Gotzsche. “Deadly Medicines and Organised Crime.” Radcliffe Publishing 2013.
3. Auckland DHB Hospital Advisory Committee meeting 30 October 2013. “Commencement of ESSURE procedures in a procedure room (previously performed in OR).”
4. Hou, MY and Creinin, MD, 2013: Update on Contraception, OBG Management; 25(8):22-19,37
Essure Now Carries an FDA Warning
It is over three years since the AWHC began reporting on the problems associated with the use of Essure, a form of permanent contraception that began causing havoc as soon as it was approved by the USA Food and Drug Administration (FDA) and released on to the market in both the USA and many other countries.1
Essure consists of two coils made of a nickel alloy and a polyester-like fibre that are inserted in each fallopian tube through the vagina. The fibres are wound in and around the inner coil and are there for the purpose of creating irritation and inflammation which causes scar tissue to grow over the coils, blocking the tubes.
The FDA approved the use of Essure in 2002 after a fast-track review process that prioritised the device because it was the first sterilisation procedure for women that could be done in a doctor’s office, without requiring an incision or a general anaesthetic. It was promoted as being a better option to tubal ligation but for thousands of women this has not turned out to be the case.
The original clinical trials also did not include control groups for comparison, so it has never been clear whether complications like back pain or heavy bleeding are higher in women who use Essure compared to those who have a tubal ligation.
Fourteen months ago dozens of women injured by Essure testified before the FDA, urging officials to pull the device from the market. FDA officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.”2 However, at the end of November 2016 the agency ordered a black box warning be placed on the device’s packaging saying it could cause cramping, nausea and vomiting, dizziness, mild to moderate pain during and immediately after the insertion of the device, and bleeding.
After insertion there are the risks of chronic inflammation, fibrosis, infect-ions, tubal blockage on only one side, perforation of the uterus or fallopian tubes followed by travel into the abdomen and pelvic cavity causing persistent pain and requiring surgical removal. Although the device was not made to be removed hundreds of women have had to undergo a hysterectomy in order to remove pieces of the coils.
Officials at Bayer, the manufacturer of Essure, claim that poor surgical skills are to blame for complications, and insist there is no proof that the device causes chronic pain and autoimmune disorders.
If all this sounds very familiar, it is. The women struggling to get recognition of the suffering caused by surgical mesh have faced similar hurdles and met with the same denials about the damage caused by that particular medical device.
However, in the case of Essure, the FDA has also taken the very unusual step of “guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.
The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.”2
As with the surgical mesh, many doctors who insert the Essure coils do not know how to remove them. It is also not known what the best method of removal is.
As noted previously in the AWHC newsletter (see below), some members of the FDA panel that approved the device in 2002 did raise a number of concerns about the device including the small numbers of women in the phase two and phase three trials, and the lack of long-term data.1 Despite the fact that Essure was meant to last for life, the FDA approved it after trials lasting only a year or two.
As well as the pain and other serious side effects that emerged in the clinical trials, it was reported that the device could not always be implanted, and it failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in ten women who try Essure cannot rely on it to prevent pregnancy. So much for the claims that it is a better alternative to tubal ligation.
By the end of 2015 the FDA had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a small number of fatalities.2
Bayer has now agreed to begin tracking 1,400 women who have the device implanted over the next five to six years. The study is supposed to report final results in 2023, but it is already behind schedule. There will also be a comparison group of sorts in that 1,400 women who choose the traditional form of sterilisation using laparoscopic surgery will also be followed.
The women in each group will be followed for three years after sterilisation to see how many develop complications such as chronic pain, heavy bleeding and autoimmune diseases, as well as how often each intervention fails, leading to pregnancy. Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.
In 2013 the AWHC reported that several DHBs were already implanting Essure. This raises the issue of the information that women are given prior to having these nasty devices inserted.
1. Williams, L. 2013: Essure: Another awful medical device, AWHC Newsletter, October 2013
2. Rabin, RC, 2016: Bayer’s Essure Contraceptive Implant, Now With a Warning, New York Times.