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.

Essure-962-939

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.