Essure – Another Women’s Health Disaster
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:
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.
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:
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:
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.
* 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.
2 Essure contraceptive device: Hazard alert - labelling update relating to potential risks, 30 August 2017, Australian Therapuetic Goods Administration
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.