Thousands of women have undergone invasive surgery to remove contraceptive implants that were designed to be permanent, according to research for the implant files.
The Essure implant, made by Bayer, was marketed as a “gentler” non-surgical alternative to traditional sterilisation methods, with women told the procedure could be carried out in a GP’s surgery in 15 minutes.
However, a Dutch surgeon who has carried out nearly 500 Essure removals described how the implant turned into a “calcified nail” inside the body and reported cases of devices having pierced through internal tissue and migrated into the abdomen.
Analysis of health records by more than 50 media partners working with the International Consortium of Investigative Journalists (ICIJ) shows large numbers of women in the UK, the US and Australia have suffered complications including chronic pelvic pain, persistent bleeding and allergic reactions.
Thousands have required keyhole surgery or hysterectomies to remove the devices.
There are no official figures in the UK for how many women have received the implants and the health regulator declined to release details of the numbers who have suffered complications or have had removal surgery.
The implants, which are 4cm long and 1mm across, are placed into the fallopian tubes. Scar tissue that builds up around them blocks the egg from reaching the womb, resulting in permanent contraception.
In a premarket trial of more than 400 women, 97% were reported to be “somewhat” to “very satisfied” at follow-up visits up to five years after the process. About 1 million women worldwide have received the implants since they were approved in Europe in 2001 and the US in 2002.
However, concerns about complications led to national health regulators issuing escalating safety warnings to patients and, behind the scenes, writing to Bayer about the number of “adverse incident” reports.
In Europe, the device’s CE (Conformité Européenne) mark for safety was suspended last year, and Bayer later withdrew a renewal application, citing commercial reasons.
In the US, the company has said it will voluntarily stop sales at the end of 2018 due to a decline in demand, which Bayer partly attributed to “inaccurate and misleading publicity about the device”.
In Australia, hundreds of women have reported severe complications. The country’s drugs and medical devices watchdog, the Therapeutic Goods Administration, announced last year that Bayer had discontinued Essure in Australia “for business reasons”.
Questions remain about whether the risks of the device are greater than initially thought. Doctors are concerned about the number of women having complex surgery to extract the implants.
An analysis of official data from the US Food and Drug Administration (FDA) database revealed 26,773 adverse incident reports, including nearly 10,000 related to implant removal.
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FDA records also contained descriptions of eight adult deaths linked to Essure, including a woman who suffered an embolism a few days after a hysterectomy to remove an implant.
The FDA said: “It is difficult for the FDA to determine whether the device caused the death with only the information provided in the report.”
Bayer challenged the figure of 10,000 removals in the US as “inconsistent with what we have seen” and said the risk-benefit profile of Essure had not changed since its approval in 2002.
The company said issues with the FDA’s reporting system, which allows members of the public to enter anecdotal reports, meant “it would be misleading to draw any conclusion about the cause or incidence of injuries based on adverse event reports”.
In the Netherlands, more than 2,000 removal operations have been performed, according to data collected on a Facebook patient forum.
A French surgeon told the Guardian his team had performed 120 removals since 2016 and estimated there may have been more than 1,000 removals nationally. Finnish doctors reported more than 100 removal surgeries.
In the UK, a freedom of information (FoI) request to the Medicines and Healthcare Products Regulatory Agency (MHRA) about the number of adverse events linked to Essure was turned down on the grounds that it was commercially sensitive information. A poll on a UK patient forum found 50 women who had had an Essure removal.
Bas Veersema, a Dutch gynaecologist who has removed implants from almost 500 women, said his clinic had to learn through trial and error how to take the implants out without the need for a hysterectomy and without leaving behind shards of metal.
During removals, he sometimes finds the devices in a “chicken wing” position with the implant swivelled so the tip is almost piercing the fallopian tube. Occasionally he has found implants floating in the abdomen, presumably after they have passed through the tube.
When placed in the body, the implants are soft and flexible, but Veersema said they hardened over time due to calcium deposits, and sometimes the surrounding tissue looked swollen and unhealthy.
“After a couple of years it’s almost a calcified nail,” he said. “We can imagine it’s causing pain. There are women in the recovery room after the procedure who tell me: ‘I feel the difference already. It’s like a nail has been pulled out of my body.’”
Veersema was an early adopter of Essure, trained other surgeons in its use and initially felt the procedure worked well and had only occasional complications.
In the past five years patient campaign groups have highlighted the problems experienced by some women. A US Facebook group formed in 2011, Essure Problems, has more than 40,000 members. A Netflix documentary, The Bleeding Edge, released in April, highlighted the traumatic complications suffered by some women.
At the same time, reporting to regulators has dramatically increased, with the FDA recording 5,019 adverse incidents in 2016 and 11,854 in 2017.
In correspondence obtained from the Dutch health regulator through FoI requests, Bayer blamed the “stimulated reporting” on media attention and a callout by the regulator that prompted 373 adverse event reports relating to Essure in 2016.
The Dutch healthcare inspectorate disagreed, telling Bayer in an email last year: “These cases show there is under-reporting of complaints without the media attention or proactive post-market surveillance by the manufacturer.”
Veersema said surveillance by healthcare systems, regulators and Bayer was not sufficient.“Because of all those stories that I’ve heard, I’m getting to believe that there’s a real relation between the problems women have [and Essure],” he said.
“If you introduce something and you think it’s safe and think it’s a nice device, you still have to follow what’s going on with those patients and it should be in a national registry.”
Bayer said: “Bayer’s highest priority is patient safety, and we are strongly committed to women’s health, an area in which we have long been a leader. This commitment requires that women have the accurate information – grounded in science and research – that they need to make health-related decisions.
“Known risks associated with Essure, like pain and bleeding, have been included in Essure’s labelling throughout the history of Essure’s commercial availability. It is important to note that the only other form of permanent contraception – tubal ligation – requires surgery and also carries significant risks.”
