CONTRACEPTION – Housed in patients' arms, Nexplanon contraceptive implants are not supposed to move. Women have been operated on urgently following the "migration" into the lungs of their implant. Health authorities are alerted.
Like about one-third of the women, Alice did not support implant placement, a seemingly ordinary situation, until the practitioner wanted to make the removal. "He found that the implant was no longer in my arm, and it took a scan to find it." Investigations that lead to a surprising discovery: "The implant was in my right lung."
After two operations, the contraceptive device (4cm long, 2mm in diameter) is finally extracted, not without difficulty. Heavy, stressful interventions that still leave a legacy. "I have a 20 cm scar on my back, and a pain under my right breast, and I had to cut a nerve to recover the implant …"
A medical error when laying
How to explain that a small implant, supposed to remain under the skin at the level of the arm, is found at the level of a pulmonary artery? "Apparently, it would have been placed directly in the vein at the time of the pose," says Alice. When he learned it, the gynecologist who had implanted him was "very shocked," recalls Alice. For her, it is a "medical error". "I had a depression after that." The laboratory (which produces the implants, Ed) was relieved of all responsibility when I contacted him.For him, only the practitioner was concerned.
Today, Alice considers that she avoided the worst: the migration of her implant could indeed lead to a removal of a lung. She does not want to bring this case to justice, but considers it essential to alert women, "so that they know that such situations can happen."
Other patients have been migrated from their implants. The Avep, Association of the victims of pulmonary embolism and stroke, published on October 29 a press release to alert the general public and health authorities. Two cases have been reported to him; "Nightmarish situations" as described by Florence Markarian, the president of the association. "We wanted to talk about it publicly," she slips, even if "at the contraceptive level, there is no quick fix, but we must have the maximum of information."
The ANSM captures these files
In France, only one implant model is marketed by the MSD France laboratory. Contacted by LCI, the latter does not speak about the specific cases of victims but specifies that "clinical training programs are offered to health professionals to allow proper use of the product." MSD ensures to remain "vigilant to the rise of undesirable effects" and indicates to deposit "regular reports with the ANSM and other regulators".
The National Agency for the Safety of Medicines and Health Products (ANSM) is aware of these "migration" cases. The public establishment tells us that in 2016, "the first reports of pharmacovigilance of migration of this implant in the pulmonary artery were reported", they then "led to the immediate establishment of a reinforced surveillance of this risk at national and European level as well as the implementation of risk reduction measures ".
The first of these measures was the addition "to the patient information leaflet and in the summary of the product characteristics" of the risk of migration in the pulmonary artery. "A letter was also sent in October 2016 to prescribers (general practitioners, gynecologists and midwives) in order to inform about the risk, the actions to be taken and to recall the training procedures for insertion / withdrawal. This missive also specified that in case of non-palpable implant at the site of insertion, a search is to be made throughout the thorax because of the possibility of migration outside the site. insertion ", completes the ANSM.
To complete these measures, "centers of excellence for the placement and removal of contraceptive implant", a dozen in France, have been created. They aspire to form the best professionals "volunteers to pose". Dramatic, these incidents are still very rare, says the agency, which reports 30 reports to date for cases of migration of implants in the pulmonary artery.
The training of the practitioners in question?
Lecturer and hospital practitioner at the University Hospital of Lille, Geoffroy Robin points out that with a contraceptive implant, "the problem is to place it really under the skin, and not in deeper areas". The medical gynecologist, who is also president of the gynecomedical commission of the National Council of Obstetricians and Gynecologists (CNGOF), reports that these are "generally problems during the pose" that lead to migrations.
As soon as the implant is slipped under the skin of a patient, "it must be palpate," he insists. "If you can not feel his presence, do not delay asking for an ultrasound of the arm, which is very powerful." In order to prevent such cases from being detected late, he recommends that practitioners and midwives – also entitled to implant placement – do not hesitate to "show patients" where they are, "and to tell them to regularly perform palpations ".
The ANSM, for the time being, wants to remain cautious as to the exact causes that lead to these movements of implants, the latter being "not established". Some tracks are nevertheless put forward: "an insertion too deep at the time of the pose, directly in a blood vessel", or even a posteriori, "either because of shock or repeated movements or because of an anatomical peculiarity". Every year, approximately 200,000 women use the Nexplanon implant, a contraceptive device that is effective for three years.
On the same subject