When Ntombi-khona Ndlovu (28), from Volksrust in the Pixley ka Seme district of Mpumalanga, went to the local clinic to get contraception, she was introduced to the Implanon NXT – a hormonal contraception device inserted under the skin on the inside of the nondominant upper arm.
The health department introduced the implant, produced by pharmaceutical company MSD, in April last year to broaden contraceptive options in the public health sector in an effort to reduce unplanned pregnancies. The device, made of silicone, is inserted under local anaesthesia.
“The nurse at the clinic told me that the implant was better than the injection because I can keep it in for three years. For me, that was better than going to the clinic every two or three months for the injection,” said Ndlovu. “I don’t want any more children. I’m fine with the two I have.”
But “a week or two” after the implant was inserted, she started getting “unbearable headaches” and the arm into which the device had been placed became so weak that she couldn’t lift heavy objects.
Ndlovu had her implant removed just three weeks after having it inserted in June last year.
She wasn’t the only person who has had problems with the device.
Pain, rash and HIV medication
Thirty-five-year old Charmaine Khuzwayo (not her real name), who is HIV-positive, had the Implanon NXT inserted in mid-2014 at the same clinic. She also started experiencing adverse effects shortly afterwards.
“I got the implant because I don’t want to have a baby. I was already on a contraceptive, so when I heard that this one lasts for three years, I decided to go for it because I have seen a lot of women my age have babies and not survive,” said Khuzwayo.
“Three weeks after getting the implant I started experiencing pain under my right breast. When the pain started I didn’t take it seriously. I went to the clinic and they gave me pills that helped relieve the pain for a while.
“But the pain came back and I also developed what looked like a heat rash.”
A few months after the device was inserted, Khuzwayo read on a support group’s social media website that HIV-positive women on the fixed-dose combination antiretroviral pill should not get the implant.
“Although I am HIV positive, I am not on treatment yet. But I got frightened of what would happen to me one day when I do start treatment. That is why I had it removed,” she said.
Clinic stops using implant
Sindi Kuhlase, the Volksrust branch organiser of the activist organisation the Treatment Action Campaign (TAC), says the Mpumalanga clinic Vukuzahke, which Ndlovu and Khuzwayo attended and where she is stationed, stopped using the contraceptive implant last year, just months after it was introduced, because of the number of women who presented with side effects.
“They all had the same story. They experienced rashes, headaches and irregular [menstrual] flow. Since last year, the nurses don’t insert it anymore, they only remove it now,” Kuhlase said.
“I don’t know if the research was wrong. In other places it seems to be fine – they don’t have problems.”
The deputy director general for maternal and child health in the national health department, Yogan Pillay, said his department was aware of the problems with the device in Mpumalanga.
“We think there was a problem in the quality of the training [for nurses], so we’ve stopped insertions in Mpumalanga. We’ve looked at why these things are happening in the province and now we’re retraining everyone,” he said.
But other provinces also seem to be experiencing problems with the Implanon NXT.
Portia Serote, the TAC’s national women’s representative, said she had personally dealt with “a large number of women in Gauteng who had the Implanon NXT removed because they were experiencing excessive bleeding”.
Serote said similar cases were being reported by other provinces.
Pillay argued that all “artificial” products come with side effects.
“When you’re implementing anything new, you have to be extra vigilant and extra careful. The important thing about any contraceptive is to explain to the woman that ‘you will have headaches, maybe irregular – less or more bleeding compared to what you usually expect’,” he said.
Nurses set to be retrained
But Pillay admitted that the training of health workers might not be up to standard.
“In some instances we do find that the explanations and counselling that we give to women who want contraception are not as thorough as we would like them to be. So we are beginning a retraining programme for all the nurses who have been trained in the insertion and removal of the implant.”
In October last year, about six months after the Implanon NXT was introduced into the public health sector, the national health department sent out a circular to all public health nurses, doctors and managers stating that “new evidence has emerged that certain enzyme-producing drugs … can interfere with the effectiveness of progestin subdermal implants”.
These include certain epilepsy medicines, Rifampicin (used to treat tuberculosis), and the antiretroviral Efavirenz (one of the three antiretrovirals in the fixed-dosed combination pill). In South Africa it is policy to put new patients, including pregnant women, who are initiated on HIV treatment, on the three-in-one pill.
But this was not new information: the warning has been included in the package insert of the Implanon NXT since 2013, when the product was registered with the Medicines Control Council.
The insert stipulates that “interactions can occur with medicinal products that induce hepatic enzymes … for example, Phenytoin, barbiturates, primidone, Carbamazepine, Rifampicin and HIV medication [such as] Ritonavir, Nelfinavir, Nevirapine”.
Nurse burn-out and ignorance
Serote said nurses were often overworked “because of the shortage of staff and that makes them ignorant”.
She said that in many facilities only one nurse was trained “and then they will expect that nurse to come and plough back the information. And when that nurse comes back from training she does not have the time to train other nurses and to tell them about the guidelines, because there are long queues and there is work that needs to be done.”
The national health department has also received complaints about women falling pregnant after the implant was inserted.
But Pillay said that in many of those cases users might not have taken pregnancy tests before the device was inserted.
“Historically, people were told: ‘When you’re menstruating come and see us, and we will put you on some contraceptive because then we know you’re not pregnant.’
“But now we are saying: ‘Come in at any point in time, but we need to do a pregnancy test [first].’ Is that done in every instance? I’m not there in every instance so I can’t tell you ‘absolutely’,” he said.
There have also been complaints about the Implanon NXT devices “moving” or “migrating” from the inside of the arm to another part of the body.
The information leaflet states that “the implant may migrate from the insertion site”. The leaflet also points out that this only happens in rare cases and “is mostly related to either a too deep initial insertion” or external forces such as contact sports.
“There have been two or three cases of migration of the implant [in South Africa],” said Pillay. “And that reflects, again, on the training and the lack of experience. Remember, we just started this, so there has been no experience in the insertion and removal of the Implanon NXT because it’s so new.
“Because it’s detectable on X-ray, we’ll find it. But this is a small number of cases. We’ve implanted about 850 000 [devices] since April 2014 [in the public sector],” he said.
But Serote is not convinced: “We were happy when the Implanon was introduced. But now, with what we are seeing at the ground level, we are starting to be scared.”In many facilities only one nurse was trained “and then they will expect that nurse to come and plough back the information … but she does not have the time” to train others.
A rod the size of matchstick deals with forgetfulness
The United Nations Population Fund (UNFPA) estimates that, in 2014, nearly half of women of reproductive age (15-49) in sub-Saharan Africa wanted to avoid pregnancy. Yet more than 50% of these women are not using “an effective contraception method”.
The unmet need for sexual and reproductive health services is mainly among the poor and accounts for more than 90% of unintended pregnancies, according to the UNFPA.
Although an estimated two-thirds of women in South Africa aged between 15 and 49 use a modern method of contraception, the high number of unplanned and unwanted pregnancies remains a challenge, says UNFPA.
In February last year the national health department launched Implanon NXT, a subdermal contraceptive implant that is said to be 99% effective in protecting women against pregnancy for up to three years.
The implant slowly releases low doses of hormones (progestin) to stop the egg from being released to meet the sperm, according to the Mayo Clinic, a US-based medical treatment service. The device is a long-acting contraceptive that leaves little room for human error.
Short-term contraceptives, such as the pill or injections, are about 97% effective if taken correctly – but failing to take the pill daily as directed or getting the shot every two or three months can lead to pregnancy.
The implant can be inserted at any point in a woman’s menstrual cycle as long as a pregnancy test has been administered and pregnancy has been ruled out.
The implant is a matchstick-sized silicone rod that is inserted under the skin on the inside of the upper arm of a woman’s nondominant arm. The insertion is made under a local anaesthetic by a trained health-care professional.