Device's side effects are users' health nightmare

Migrating Jadelle rods in Rebecca Warren's arm required a surgical - and expensive - hunt to find and remove them. Photo / Vision Media

The Ministry of Health's Medsafe has stepped up warnings to GPs about a contraception rod, as thousands of Kiwi women turn to the seemingly trouble-free protection from pregnancy. Concerns are rising that side effects are not being made clear to patients

Rebecca Warren will always have a sugar-cube shaped red scar on her arm to remind her of the Jadelle, a contraceptive device that sat under her skin.

The scar will fade, but the mental scars remain.

When the 20-year-old student from Palmerston North was looking for an alternative to the pill, she thought the Jadelle sounded just right - two matchstick-size flexible plastic rods, inserted beneath the skin in the inner arm.

She wouldn't have to worry about taking the pill every day, or the potential side effects. She was told the new contraception would provide protection from pregnancy for up to five years.

But just two weeks after the rods' insertion, Warren was miserable with constant pain.

"It just wouldn't go away unless I was taking the oral contraceptive pill (on top of having the implant)."

Her doctor told her to go back on the contraceptive pill. This stopped the bleeding, but when she went off the pill again, the bleeding returned. After 18 months of to-ing and fro-ing, she decided to have the pair of rods removed.

Rebecca Warren says her arm is still sensitive and sore to touch despite having the implants removed seven months ago. Photo / Vision Media

"It had moved in my arm and had sewn itself to my tissue in my arm so was difficult to remove."

Warren's doctor had to cut away the tissue around the device, which left her with a line of hard scar tissue under the skin and a bright red scar where he cut a hole to get it out.

"This area of my arm is still very sensitive and sore to touch even though it was removed over seven months ago," Warren says.

"The most frustrating thing was it didn't do what I was led to believe it would, and how it was expensive paying for doctors' appointments to get it sorted out."

The Jadelle has been subsidised by the Government since 2010 and, according to Medsafe, 38,000 New Zealand women are now using the contraceptive device.

Unsurprisingly, women are leaping at what's been touted by some as the greatest revolution in women's contraception since the introduction of the pill in the 1960s. It is proving popular among young women looking for a safe, trouble-free alternative to oral contraceptives and the danger of blood clots.

This month, Social Development Minister Paula Bennett enthused about the long-acting reversible contraceptive (LARC) saying that she wished "something like this had been available when I was younger".

"I'm excited with the development of LARCs giving women better contraception options."

Referring to a Government contribution of a $1 million towards long-acting contraception in the 2012 Budget, Bennett says she's proud that Work and Income is offering to pay grants for LARCS to low-income women.

Since the subsidy, Pharmac has seen a rise in implant prescriptions and a slight drop in oral contraceptive prescriptions.

But concerns about the Jadelle are growing. Even though the New Zealand distributor's publicity brochures claim the rods "generally" don't move once inserted, doctors are finding they migrate around the body and can become so difficult to remove women require expensive specialist treatment.

Health authorities have known about the migrating rods for three years but have not warned GPs and others prescribing the Jadelle.

Wellington radiologists John Denton and Joe Feltham, of Pacific Radiology, have taken out five Jadelle implants in the past two years that had migrated. GPs could not find the rods and had referred the patients for ultrasounds.

Feltham says one rod had moved almost 10cm towards the patient's armpit and she needed an ultrasound to find it.

He says the Jadelle can lie very close to the brachial artery, a major artery in the arm. The rods can't migrate into the artery but can get near it, he says.

"This makes it more challenging when removing because you don't want to cut it (the artery). You have to be very, very careful with dissection; the same goes with major nerves and you don't want to cut any of those. That's why ultrasound is important with removing these."

Feltham says he removed a Jadelle recently in which the rods had formed an "x" which, given that they were inserted at the same time, was "quite strange".

Denton says as the rods are very soft plastic they don't show up easily on ultrasound and it makes them hard to get a grip on.

"Most GPs may or may not be set up for small surgical procedures like this. It's really not easy to grab and get out. In terms of removing foreign bodies, it's one of the most difficult I have ever had to do."

Several GPs were contacted for this article, but only Palmerston North GP Dr Esther Willis was willing to talk on the record about the Jadelle.

"It's harder to take them out than put them in and one I tried to take out I had to get one of the other (doctors) to do it," she says. "As soon as you make a cut, it always bleeds and you can't really see where you're going."

Willis says she recognises the Jadelle as being an effective contraceptive but says that making sure patients know the risks is key.

A 29-year-old Palmerston North woman, who does not want to be identified, says she was not told of the risks when getting the Jadelle contraceptive.

The mother-of-one had the Jadelle inserted in 2011. Straight away, she experienced weight gain, severe hormonal depression, flatulence and lack of energy - things she had never suffered before.

"I can't do a lot of things because I sleep most of the hours that I'm not working, which my son and I are both affected by.

"The flatulence is uncontrollable and can be humiliating so I do not like to go out for too long. My bowels are also affected due to the food intolerance the doc seems to think I have now."

She says that when she had the Jadelle inserted she remembered her doctor telling her it would not move.

"(Then) when they went to get it out they had to dig for it and she said, 'Oh it might have moved a bit'."

She had to find another doctor to remove it because her own GP couldn't.

It's clear that many women and their GPs aren't aware of some of those risks. A Jadelle publicity brochure, published by distributor Bayer NZ, states that its side effects are rare but can include bleeding, headaches, nausea, acne, pelvic pain, dizziness.

However, the booklet - widely distributed throughout New Zealand - does not mention the risk of migration. Instead, it states: "Will the implant move around? No. They will remain under the skin where they are placed."

Bayer Corporate Communications adviser Rachel Harvey says that statement is from an old booklet and a new booklet, produced last year, has changed that wording to: "Generally, they will remain under the skin where they are placed".

She says the booklet is distributed to medical centres "as requested" but Bayer has not recalled previous versions.

Asked whether adding the word "generally" fully disclosed the possibility of migration, she said GPs had all the necessary information about Jadelle and the information was also publicly available from Medsafe.

Medsafe is charged with ensuring that medicines and medical devices are acceptably safe. But its consumer information leaflet on Jadelle, dated November last year, does not list migration as a risk.

Asked why migration is not listed on the information leaflet, Medsafe's senior medical adviser, Dr Sharon Sime, says the leaflet instructs that the insertion site should be checked at all follow-up visits.

It also advises patients to report any unusual symptoms not listed in the Consumer Medsafe Information.

Questions on the information should be directed to Bayer NZ, she says.

After questions from the Herald on Sunday, Medsafe has this month issued a new update to GPs.

This includes information about the possibility of the rods migrating.

But information sheets for consumers have still not been updated.

The new prescriber update says that up to June this year, 21 confirmed reports of Jadelle's migration or removal difficulties have been reported.

Only three were reported with the LARC Implanon.

Paul Smith, the NZ director of Implanon distributors Merck Sharp & Dohme, says their device was put forward as a LARC at the same time as the Jadelle, yet Pharmac funded the Jadelle.

Pharmac says it ran a "competitive process" with suppliers in 2010 to select one LARC device. Director of operations Sarah Fitt says Jadelle was chosen as the best option for "value and efficacy". Running a competitive process and selecting only one encouraged suppliers to offer their best price. However, Pharmac is considering running another competitive process involving LARC devices, she says.

Sam Windsor chose the Jadelle because it was subsidised.

Sam Windsor, a Wellington call centre worker, chose the Jadelle despite her GP telling her Implanon would be better. But, at $350 plus the cost of insertion, Implanon was considerably more expensive than the Government-funded option.

The cost of inserting the Jadelle is about $65 but Windsor says her experience with it is one she would like to forget.

She suffered heavy bleeding, personality changes and an increase in hair growth. The outgoing, bubbly 21-year-old became moody, snappy and lost motivation at her job in customer services.

When she finally managed to get it removed at a Wellington Family Planning clinic, she vowed to quit taking any hormonal contraception.

"I've had a few people ask me what the rod was like. I tell them it is their choice but I would not recommend it to them, or anyone. The side effects are just terrible."

So where does that leave women who have had to pay for expensive specialist treatment to locate and remove the Jadelle?

Lawyers and the ACC say some of the women using the device may have cases for compensation.

Wellington solicitor Michael Okkerse, who specialises in medical cases, says that where the Jadelle had migrated or not done what contractually it should have, there can be grounds for compensation.

In cases of women who had paid for their devices, rather than getting them free through a GP or Family Planning as a government-subsidised product, they can be covered by the Consumer Guarantees Act.

Okkerse says that since the device is manufactured overseas, there can be grounds to sue if not precluded by ACC.

ACC senior media adviser Stephanie Melville says there can also be grounds for compensation through treatment injury in cases where there are severe side effects.

"If there had been an issue with the insertion and it had not been done correctly and then there had been resulting problems (it) would certainly warrant lodging an injury treatment claim, but it is not a one size fits all so it would come down to specialised medical assessment."

Sam Windsor says she won't seek compensation as it was her choice to try Jadelle.

But she would have liked some statistics at the time of her decision showing how many women had had the Jadelle removed early and why.

"I think that would have helped my decision in whether or not to have it. It would be good to have a website about it that was straight up maybe some testimonials from people, good, bad, a big range."

Rebecca Warren says she would tell others considering the Jadelle to be careful.

"I would tell them what I experienced and that it's supposedly different for everyone, so they can try it if they want to, but it may not work exactly as the doctor hopes."

Jadelle in NZ

• Pharmac began subsidising Jadelle, a long-acting reversible contraceptive (LARC), in 2010.
• Last year, the Government announced $1 million over four years towards LARC subsidies.
• 38,000 New Zealand women are now using Jadelle.
• Concerns are increasing about migration of the Jadelle rods, making them difficult to locate and remove in some cases.
• 21 cases of migration or removal difficulty were reported up to June this year.
• Medsafe has this month updated its warnings to GPs about migration.