Essure – Another Women’s Health Disaster
It would be easy for women to come to the conclusion that the medico-pharmaceutical industry gives little thought and consideration to its approach to women’s reproductive health. There is a plethora of shameful examples in the last 60 years alone, in which women have suffered considerable harm as a result of “well-intentioned” devices, treatments, procedures and drugs to address issues associated with their reproductive health. To name a few:
- Diethylstilboestrol given to prevent miscarriage, which resulted in a significantly increased risk of breast cancer in the mothers (recipients of the drug), and reproductive tract deformities, infertility and pregnancy loss, as well as an astounding increase in the risk of an otherwise rare vaginal cancer and increased risk of breast cancer, in the daughters.
- Thalidomide prescribed for morning sickness which caused severe birth defects in the mothers’ babies.
- Primodos, a hormonally based pregnancy testing drug that led to severe birth defects in babies of mothers given the drug.
- HRT prescribed to women for menopausal symptoms, which led to a significantly increased risk of breast cancer.
- New Zealand’s rather underwhelmingly labelled “unfortunate experiment”, which should need no introduction and involved experimental lack of treatment for women with pre-cancerous cervical cell changes without the women’s consent.
- Surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence, which have left as many as 12 to 15% of women implanted with the mesh in crippling pain, with some unable to walk unaided or confined to a wheel chair, and many with no prospect of being able to have sex for the rest of their lives.
We can now add the Essure hysteroscopic sterilisation device to the list, albeit the apparently relatively low uptake of the treatment has meant that, in New Zealand at least, injury and ill health caused by the device appears to have been limited.
Essure Hysteroscopic Sterilisation
Essure is a permanent sterilisation device that has been offered as a less invasive alternative to tubal ligation, and which can be implanted in the fallopian tubes without an incision or anaesthetic. The device comprises an inner core of inner polyethylene terephthalate fibres, held in place by a flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. The polyethylene terephthalate fibres are designed to work by stimulating an inflammatory response causing the growth of benign fibrous tissue that blocks the fallopian tube over a period of three months. The procedure is non-reversible and if side-effects occur the only method of removal is surgery to remove the fallopian tubes. In New Zealand this is only offered as part of a full hysterectomy, although in the US some surgeons offer a limited surgery that removes only the fallopian tubes.
Lynda Williams wrote about the Essure device three times, in the October and November 2013 AWHC newsletters and in the December 2016 newsletter. All three articles can be found on the AWHC website.
In October 2013 Lynda introduced the device thus:
“Over the past ten years another insidious experiment has been undertaken 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.”
Over time, so significant were the adverse effects of the device, sales of Essure were suspended in Brazil and the European Union before manufacturer, Bayer, in 2017, withdrew it from sale from all countries around the globe, except the US.1
Despite the very poor safety profile, the banning of the device in several countries and the addition of an FDA black box warning in 2016, Bayer insisted that its decision to pull sales and distribution was “not related to a question of safety or dangerousness of the medical device whose positive benefit-risk profile remains unchanged.”1
In August 2017, Australasian Medical and Science Ltd (AMSL), in consultation with the Therapeutic Goods Administration, issued a hazard alert for Essure, recalled unused stock and withdrew the device from the Australian market.2
In Brazil in February 2017, the regulatory agency Agencia Nacional da Vigilancia Sanitaria (ANVISA) became the first to suspend sales and recall the device, and based their decision on technical and scientific reports.3 ANVISA categorised the device as presenting maximum risk owing to certain side effects, including:
- changes in menstrual bleeding,
- unwanted pregnancy,
- chronic pain,
- perforation/migration of the device,
- allergy and sensitivity or immune-type reactions.
The US FDA continues to support use of the device in the US, and as of December 2017 said on their website that “the FDA continues to monitor the safety of Essure. The FDA continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labelling helps to assure that women are appropriately informed of the risks.”4
Given the suspension of sales in many countries before Bayer withdrew the device, and the high number of lawsuits taken against Bayer over the device in the US, it seems that the FDA’s confidence in it is somewhat misplaced. The website Drugwatch says that Bayer faces thousands of lawsuits in the US as of October 2017 although they have yet to settle in any case.5
Drugwatch5 goes on to say that the lawsuits claim Essure complications, including device migration, bleeding, device fracture and other complications requiring surgery, damage to organs and the birth of children with birth defects after the failure of the device to prevent pregnancy. Apparently Bayer is protected against liability by pre-emption laws, but judges are allowing lawsuits to continue despite this.
In their 2017 Annual Report, Bayer make the following statement:
Essure™: As of January 30, 2018, U.S. lawsuits from approximately 16,100 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated.
As of January 30, 2018, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.6
In their 2016 Annual Report, Bayer disclosed that they had impairment losses of €391 million (approximately US$413 million) in connection with Essure.7 In 2017 the Annual report specifically stated6 that expenses related to significant legal risks “amounted to €258 million in 2017 (2016: €262 million), which, as in the previous year, primarily included expenses in connection with litigation relating to the products Xarelto™, Essure™ and Cipro™/Avelox™.”*
Essure in New Zealand
It seems that New Zealand women may have gotten off fairly lightly in terms of the damage caused by Essure. There is not a lot of information available on the use of Essure in this country and there is currently no mention of it at all on the Ministry of Health website. We can ascertain from media reports that Essure became available in about 20038 and was then publicly funded through DHBs from about 2010.9 However, it is evident from responses to enquiries by other organisations, such as the Palmerston North Women’s Health Collective, in recent years, that not all DHBs offered Essure in their hospitals.10
The AWHC sent out requests for information on the use of Essure and any adverse impacts it caused to a number of agencies, including the Auckland metro DHBs including National Women’s Hospital, ACC, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Medsafe, and distributor from 2009, NZSL.
The requests sought information on:
- the period of time Essure was used/available here;
- if there are any residual stocks of the device in New Zealand;
- the number of women who had the devices implanted in New Zealand;
- if any adverse event/reaction reports were lodged with regard to Essure;
- if Medsafe ever received any information on, or issued any warning about, the safety of Essure;
- if any medical injury claims have been lodged with ACC as a result of women having had Essure implanted, and if so, were any accepted, and how many and what was the cost of those claims to ACC.
So far, the information that has come back is sparse and not very informative. Many of the requests were treated as OIA requests and we are still waiting on responses, including from Medsafe, the WDHB and ADHB/National Women’s Hospital.
The CMDHB responded that Essure was never used in the DHB.11
ACC responded that:
“After a search through our treatment injury database, as well as our database for personal injury claims, we have been unable to identify any claims relating to, or mentioning, the Essure device.”12
This appears to support an earlier letter to Lynda Williams in 2013, in which Medsafe said that at that time there had “been no reports of adverse events or complaints relating to the use of [Essure].”13
Jane Cumming from RANZCOG advised that ADHB started the Essure procedure in March 2010, did 240 procedures and did the last one in August 2017; one patient who had a previous background of chronic pain had the device removed.14 Ms Cumming added that residual supplies were removed by Bayer in August 2017.
Essure Update – May 2018
Since the article on Essure was published in the February-March 2018 edition was published, AWHC has received some further information on the use of the device in New Zealand. Bayer has confirmed that the device was removed from sale in 2017 and that no residual stocks remain in the country.
Initially the response from Medsafe was limited and did not include information over the entire time period that Essure was available in New Zealand, only for the period since Bayer bought the manufacturing rights from Conceptus. They also refused to answer some questions including a question about the number of devices used/procedures done in New Zealand for reasons of commercial confidentiality.
Medsafe did say that they had been notified by Bayer that “Essure was to be discontinued by the company based on low volume sales” and that Medsafe “did not issue any warnings to practitioners using Essure in sterilisations or to the general public.”
After further correspondence in which we asked for clarification Medsafe responded that until 2004, “there was no legislative requirement for medical device suppliers to notify Medsafe/Ministry of Health of devices supplied into New Zealand.”
They went on to say that “research into archived files has identified that Obex Medical Ltd (NZ) notified a contraceptive device manufactured by Conceptus to the WAND database on 7 August 2007 and transferred the rights to the product to New Zealand Medical & Scientific Ltd on 15 July 2009.” However, they don’t have any information of whether Essure was sold in this period, although other sources clearly prove that it was.
The Waitematā DHB responded that Essure is no longer being used in the WDHB, and that at the time Bayer discontinued supply WDHB had “four Essure devices in stock – all of which were discarded”. No devices were implanted after 5 September 2017, but between 2011 and 2017 there were 31 women who received an Essure device at WDHB; none have been removed at WDHB as a result of adverse reactions and/or side effects.
* There was no breakdown of costs against specific products, so there is no way of telling what proportion of these figures were a result of legal action over Essure specifically.
1 Ennis, HK, 2017: Bayer Stops Essure Sales Worldwide Except For United States
2 Essure contraceptive device: Hazard alert – labelling update relating to potential risks, 30 August 2017, Australian Therapuetic Goods Administration
3 Essure: Suspended in Brazil, Business as Usual in the USA, 3 March 2017, Drugwatch
4 FDA Activities: Essure, last updated on 7 March 2018
5 Michelle Llamas, Essure Lawsuits, Drugwatch
6 Bayer Annual Report 2017 (augmented version)
7 Bayer Annual Report 2016 (augmented version)
8 Johnston, M. 2003: Sterilisation technique offers quicker recovery for women, New Zealand Herald, 30 July 2003.
9 Johnston, M. 2010: Less invasive sterilisation choice for women. New Zealand Herald, 18 August 2010.
10 Barbara Robson, Federation of Women’s Health Councils, personal communication.
11 Lauren Young, CMDHB, personal communication.
12 James Funnell, ACC Media, personal communication.
13 Chris James, 25 October 2013: letter to Lynda Williams, AWHC, re Concerns regarding the contraceptive device Essure, held in AWHC files.
14 Jane Cumming, RANZCOG, personal Communication.
Essure: Another Awful Medical Device
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.
Update on Essure
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.
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.
Free Long Lasting Contraceptives for Teens
In an article that appeared in late June in the British Journal of Obstetrics and Gynaecology, senior academics at the University of Otago made the case for an opt-out programme that would see teens started on long-acting reversible contraceptives (LARCs) before they become sexually active.1
The three long-acting contraceptives the academics had in mind are the copper IUD which lasts for ten years, the Mirena IUD which lasts for five years, and the Jadelle implant which lasts for five years. The latter device became funded by PHARMAC five years ago.
The resulting publicity in the New Zealand media focused solely on one side of this highly-charged debate and totally ignored the contrary view put forward on the same page and in the same issue by Alison Edelman who argued that pre-emptive use of such contraceptives without need or benefit may cause more harm than good. Referring to the three Otago University lecturers as “researchers” further confused the situation as it implied that the proposal was based on new research results when this was not the case at all.2
As women’s health groups around the country expressed their disbelief and outrage at the prospect of young girls being targeted as candidates for an opt-out programme involving the use of long-term hormonal contraceptives, Dr Neil Pickering was quoted as saying “We would see it happening as a normal part of a person’s health care through school, just in the same way children are vaccinated.” This would save adolescents from having to go and seek care, he said.2 Of course, the adolescents he was referring to were all female. Perhaps he was thinking of 12-year-old school girls having the HPV vaccine Gardasil in one arm while a contraceptive implant is inserted in the other arm.
For some of us the suggestion brought back memories of the bad old days when young Māori and Pacific young women were often injected with Depo Provera without their knowledge or consent.
Fortunately, this time round Family Planning was against the idea of young women being part of an opt-out contraceptive programme. Family Planning’s chief executive Jackie Edmond said most young women aren’t having sex before they turn 16. “We’re overkilling it putting implants in people who aren’t intending to or aren’t having sex,” she said.3
Teen pregnancy rates declining
It is worth noting at this point that a recent report published in January 2015 by the Social Policy Evaluation and Research Unit stated that while New Zealand has the second-highest teen pregnancy rate in the developed world, rates were declining in all regions except Northland. In 2013, the proportion of all births that were teen births was 5.9% – the lowest ever recorded – and 71% of the births were to 18 and 19 year old mothers.4
The Abortion Supervisory Committee reports over recent years have also recorded a declining teenage abortion rate. The rate has halved between 2007 and 2013.
So let’s not get too carried away here about the teen pregnancy “problem.”
Who takes responsibility?
Jackie Edmond also commented on the issue of young women being made to take full responsibility for contraception even before they become sexually active, thus giving young men a free pass, as it were.
Following on from this, radio show host Kerre McIvor wrote in her column in the Herald on Sunday that Family Planning “believe young women should be able to have a choice when it comes to contraception and that young men should be using condoms, no matter what form of contraception young women are on. Well, good luck with that message getting through.”5
She was one of the few commentators to question the health implications of hormones being released into the bodies of young women who are still growing, developing physically as well as emotionally.
The link between oral hormonal contraceptives and breast cancer has been known for a decade or more. Extreme caution must be used before health authorities begin planning a mass programme of inserting hormonal implants in young teenage girls. Then there is the issue of it being much easier to implant these devices than it is to remove them.
Kerre McIvor went on to say:
“Sex is about so much more than not getting pregnant and I think the researchers are missing the point on that. It’s about a desire to be wanted, a desire to belong, and, far too often, it’s about power and control.
One of the correspondents to my radio show had an excellent take on the issue: vasectomies are a low cost, relatively simple operation these days. What’s more, they’re reversible. So why not offer free, universal vasectomies to all 13-year-old boys who can then reverse the vasectomy if they want children in the future? Surely that’s a suggestion as worthy of debate as inserting IUDs in the uteruses of the nation’s adolescent girls, or pumping them full of hormones.”5
It certainly is. So let’s begin the debate about a school-based programme for Gardasil and vasectomies for 13-year-old boys.
- BJOG Debate. British Journal of Obstetrics and Gynaecology. June 2015
- 5. http://www.nzherald.co.nz/lifestyle/news/article.cfm?c_id=6&objectid=11475884
Free Access to the Emergency Contraceptive Pill
Pharmacists have joined the call for the emergency contraceptive pill (ECP) to be made freely available to young women after three DHBs found that subsidising the ECP resulted in a drop in both the number of abortions and in the teen pregnancy rate.
Currently two DHBs are still funding free access to the ECP for women under the age of 25.
Waikato DHB has subsidised access to the ECP for almost four years, after pharmacists in the area reported that young women were coming into their pharmacy requesting the ECP and then leaving without it when told that it would cost $35. Around 400 women a month are accessing the ECP and the DHB has noted a reduction in the number of teen pregnancies and in the number of abortions. There is no restriction on the number of ECPs as Waikato DHB funds the service on a as needs basis.
Mid Central DHB
Mid Central DHB is reaching the end of a two-year trial of subsidising free access to the ECP and have reported a 7.5% drop in the number of abortions at the end of the first year. The current funding for the trial is due to end at the end of June 2011 and costs the DHB $98,000 a year. Around 170 women a month are provided with free access to the ECP. A Board spokesperson described the service as a fence at the top of the cliff instead of an ambulance at the bottom.
The Auckland DHB ran a 5-month trial of providing free access to the ECP from October 2008 to March 2009 at a cost of $300,000. Pharmacists were reimbursed at a cost of $47+GST per ECP which included the cost of the drug, the dispensing fee, the cost of condoms, and the cost of the pamphlet detailing how the ECP should be taken. Around 1700 women per month were provided with free access to the ECP. A subsequent report to the Auckland DHB Community & Public Health Advisory Committee on 16 June 2010 stated that the busiest pharmacies were those situated in malls or in high pedestrian zones. There was a 13% drop in the abortion rate but this was regarded as not statistically significant because of the short period of the trial and the relatively low numbers.
It was noted that “the ‘other’ ethnic category utilised the service most (65%), followed by Asian (21%), Pacific (8%) and Maori (6%). This parallels with the ADHB population which consists of 59% ‘other’, 22% Asian, 12% Pacific and 7% Maori.”
The report pointed out that the price of a first trimester termination of pregnancy at Epsom Day Unit is $994, and that termination of pregnancy rates for Maori and Pacific women are considerably higher than for European and Asian women.
Despite that fact that one of the key findings was the clear downward trend in terminations rates in Asian and European ethnic groups, and that “the positive trend observed provides confidence that this type of service will be of benefit to ADHB financially and the population on a psychological and social level,” Auckland DHB has no plans to extend the ECP pilot at this stage.
Women in the Auckland DHB area are still able to obtain the ECP free from family planning, and are able to purchase it over the counter from a pharmacy, or by visiting a GP and obtaining a prescription – and some funding is directed towards making this service free with Procare Network Auckland for under 18-year-olds.
West Coast DHB
The West Coast DHB provides access to the ECP to under 22-year-old young women at a cost of $3.
Other DHBs have different schemes in place regarding access to the ECP.
Family Planning Support
Jackie Edmond, the CEO of the Family Planning Association (FPA), appeared on Radio NZ Checkpoint on 3 February saying FPA would like to see the ECP subsidised across all pharmacies.
It would certainly be extremely beneficial for women. And for cash-strapped DHBs is makes good economic sense – a $35 pill compared to nearly $1,000 for an abortion is a no-brainer.
- Radio NZ Checkpoint. 3 Feb 2011
- ADHB CPHAC Agenda papers 16 June 2010
Third Generation Pill Story
On 4th March 2011 the University of Otago’s department of Preventative & Social Medicine celebrated 125 years Public Health Teaching and Research by hosting a symposium in Dunedin in honour of Professor Sir David Skegg. Lynda Williams attended the symposium and reports on the presentation given by Lianne Parkin, a senior lecturer in Epidemiology in the Department of Preventative and Social Medicine at the University of Otago. Before undertaking training in public health medicine and epidemiology, Lianne worked for several years in general practice and in sexual and reproductive health clinics. She is currently involved in a project which aims to improve post-marketing surveillance of medicine safety in New Zealand.
Lianne Parkin’s presentation at the Dunedin symposium described the events surrounding the use of the third generation contraceptive pill in New Zealand.
In 1995 following the publication of three European studies showing that there was an increased risk of venous thromboembolism (blood clots) in women using third generation contraceptive pills, a warning was issued about the safety of four brands of these contraceptive pills – Minulet, Mercilon, Marvelon, and Femodene.
The risk of blood clots for third generation contraceptive pills which contain gestodene as well as oestrogen, was estimated to around twice that of second generation pills. Although the risks of blood clots for both are comparatively low, the sudden deaths of healthy young women created a great deal of publicity both in New Zealand and in other countries. In New Zealand in 1995 80% of oral contraceptive pill users were taking a third generation contraceptive pill, the highest percentage in the world. The Netherlands the figure was 63%, in the UK 50%, in both Canada and the USA 15%, and in Australia 5%.
Following the publication of the European studies, an urgent meeting was convened in Geneva in July 1995. A vast amount of reanalysis of the data was subsequently undertaken, mainly by the pharmaceutical industry and by pharmaceutical-industry sponsored groups. Eventually, independent research confirmed the original results.
When the story of the increased risk broke the Ministry of Health sent out a warning to doctors, but then withdrew it a week later. Once the results of the reanalysis were available, the MOH sent out new information that basically said that it was not necessary to alter prescribing advice if women are told of the risks in using third generation contraceptive pills. Not surprisingly, the Ministry’s prescribing advice had minimal impact on doctors’ prescribing practice. The Medicines Adverse Reactions Committee (MARC) objected to such a low key approach, as did a number of women’s groups.
In May 2000 a letter from the Royal Australia and New Zealand College of Obstetricians and Gynaecologists was published in the NZ Medical Journal maintaining that there was no difference between the second generation and third generation pills. An article by Christine Roke from Family Planning and Paul Egermayer was also published in New Ethicals Journal in January 2000. The letter and article were criticised as being misleading and inaccurate as both misrepresented the research data.1
Professor David Skegg commented at the time: “The debate on third generation oral contraceptives has been acrimonious, partly because it has challenged both strong commercial interests and the natural reluctance of prescribers to accept that trusted products have potentially done harm.”
20 healthy young women died
The MOH subsequently released figures that showed in the decade between 1990 – 2001, 20 NZ women using combined contraceptive pills died of a blood clot in the lungs. Of those who died, 15 were using third generation pills. Five of those deaths occurred in the years 1997/1998. Many other women suffered a blood clot and survived, although with a vastly reduced quality of life. By 2001 the use of third generation pills in NZ had more than halved.
Unfortunately the story doesn’t end there. A recent study published in the British Medical Journal in April 2011 showed that women using Yasmin, an oral contraceptive pill containing drospirenone (a new progestogen) were about three times more likely to develop blood clots. Concerns about this pill have been around for almost a decade.2 But once again the pharmaceutical industry – in this instance, Bayer – has been reluctant to admit that their “new” oral contraceptive pill containing drospirenone carried almost three times the risk of blood clots than the second generation contraceptive pills containing the older form of progestogen. The much touted reduced side effects with Yasmin have also turned out to be little more than a marketing ploy. And once again healthy young women have paid with their lives.
1. Letter to New Zealand doctors, midwives and pharmacists about third generation oral contraceptive pills – June 2000
2. Parkin, L, Sharples, K, Hernandez, RK, and Jick SS, 2011, Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ, Apr 21;342:d2139.