Over 250 women across Finland have had their Essure birth implants surgically removed since early 2017 after experiencing unexplained side effects, according to data collected from hospitals countrywide for an Yle survey.
According to the National Institute for Health and Welfare (THL), the exact figure for those who chose to remove the implant is not available yet. The National Supervisory Authority for Welfare and Health (Valvira) has reportedly received over 500 incident alerts from the Essure manufacturer, healthcare professionals and citizens about symptoms purportedly triggered by the implant.
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Essure is a permanent female sterilisation device — a metal coil inserted into the fallopian tubes which creates a barrier that keeps the sperm from reaching the eggs. Around 8,000 women in Finland have undergone the Essure implantation procedure.
After the procedure, many of the women have reported symptoms ranging from acute abdominal pain, swelling and headaches to weight gain and mood swings. Medical professionals were unable to directly link any of the symptoms to the implant, which the women said added to their frustration as they would often come back from the doctor feeling clueless.
Some women denied removal surgery
Johanna Kortesluoma is one such woman who got the Essure surgically removed after she started experiencing adverse side effects after it was implanted in 2014. A couple of weeks after the procedure, the 39-year-old experienced inflammation and pain in the lower abdomen, apart from a constant sense of unease. Her doctor dismissed her symptoms during a follow-up examination.
"It was clear to me that the swelling was due to Essure as it started right after the implantation. But I was afraid that the doctor would associate my symptom with my thyroid gland," said Kortesluoman, who suffers from hyperthyroidism.
In 2016, her symptoms worsened — she suffered from fever, fluctuating blood pressure and shaking fits. It was only after she joined a Facebook group of women who suffered from similar issues that she learnt that some women stopped experiencing symptoms after they got their implants surgically removed. After being dismissed by the Turku University Hospital, she chose to get the removal surgery done in Tampere.
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"Even if only a few of the women have problems, this should not be a reason to dismiss or neglect symptoms. I still wonder how this can happen in Finland," Kortesluoma exclaimed.
Bayer, the manufacturer of Essure discontinued sales in Finland in 2017, citing lack of demand. Since then, sales in Europe and the US have been terminated due to lack of demand. Essure has come under fire for years with women around the world reporting adverse side effects after implantation.
Yet, doctors are sceptical about the symptoms.
"In some patients, symptoms have already started before the Essure implants are inserted. Tiredness, fatigue or depression are not enough reasons for surgery," Jaana Fraser, chief of gynecology and obstetrics at North Karelia Central Hospital, said.
"Fortunately, the Essure hysteria has not spread to our area," Liisa Tikkala, chief physician at Kymenlaakso Central Hospital noted.
Many respondents revealed that they had to travel to another hospital district to get their implants removed as they were denied surgery in their area or their symptoms were not taken seriously enough.
Most of the Essure devices were removed over a period of less than three years at Helsinki University Central Hospital, where more than a hundred procedures took place. Dozens of women have also had implants removed in the Pirkanmaa region. It is estimated that at least 50 women have undergone surgery at the Tampere University Hospital.
Class action lawsuit
Based on their personal experiences with the implant, 161 women filed a class action lawsuit against the Essure manufacturer Bayer. However, earlier this year, the consumer ombudsman rejected the claim citing that the women’s symptoms are not consistent and noting that an investigation would prove too lengthy and expensive.
According to a survey of 140 people conducted by support group 'Essure Problems in Finland', symptoms completely disappeared after surgery in more than half of the respondents. About 10 percent of respondents felt that surgery had no effect on their symptoms.
"Patient numbers have fluctuated according to the media reports. We've had patients who absolutely want Essure out of their system," Jari Sjöberg, Chief of Gynecology and Obstetrics at Helsinki University Central Hospital.
Doctors who responded to the survey believe that pain is the main symptom Essure causes.
"Implants do not cause weight gain, loss of libido, headaches or mood swings. Not all the pain is attributable to Essure. Some patients are more objective, and once they are provided with information, they decide to keep their implants," Sjöberg added.
Removal also risky
Doctors say there is reason to be cautious because the removal surgery comes with its own dangers.
Eila Suvanto, specialist in Obstetrics, Gynecology and Gynecological Radiotherapy at Oulu University Hospital, pointed out that the implant cannot be extracted without removing the fallopian tube.
"Some patients have the idea that the fallopian tube can be saved and sterilisation can be reversed with the removal procedure. A patient may change her mind about surgery after hearing this," Suvanto said.
Urogynecologist Kaisa Raatikainen from Kuopio added that a hysterectomy is the only sure way to remove the implants. In cases where a complete hysterectomy is not performed and only some of the uterus is removed, parts of the device may remain in the patient, according to Raatikainen.
Women who underwent the surgery, Finland’s five central hospitals and all the university hospitals participated in the Yle survey. Sources used in the story include statistics from Valvira and THL, Johanna Kortesluoma's patient records and the class action lawsuit data.