Questioning the Benefits of Jadelle

Jadelle is a contraceptive implant currently widely promoted, and available free to women in New Zealand, although associated costs such as doctors fees still need to be paid.  It is also available to beneficiaries and their daughters over the age of 16 under a scheme where all associated costs (including travel) will be paid for by WINZ.

The implant has been touted as being a solution to many of New Zealand’s social ills,  including child abuse, abortion and teenage pregnancy.  According to an article published on Stuff.co.nz, approximately 20,000 New Zealand women have had Jadelle inserted.

Jadelle’s predecessor Norplant, was surrounded with controversy.  In the US, use of this contraceptive implant ceased after more than 200 lawsuits (involving more than 50,000 women) were brought against the manufacturer Wyeth-Ayerst Laboratories.  The lawsuits alleged inadequate warnings of side-effects.  Jadelle is not available in the United States, although it has been approved by its Food and Drug Administration.

How Jadelle Works:  Comprising of two rods, the device is inserted into the upper arm of women and provides contraception for up to five years.  It does this by slowly releasing into the women’s system the hormone levonorgestrel, which is a low-dose progestin.

The Jadelle implant works in three ways:

1. Inhibits ovulation;

2. Thickens cervical mucus;

3. Alters the endometrium (lining of the uterus) so that it is hostile to receiving the newly conceived human being.

The third mode of action makes this contraceptive an abortifacient.  It is highly likely that women using this implant will ovulate and conceive from time to time, therefore it is  possible for her to abort, without knowing, at least once or twice a year.

Side Effects while using Jadelle:  There are many different side-effects that can be experienced while a woman has Jadelle inserted.  These range from such things as  nausea, depression, nervousness, headaches and weight gain to pelvic pain and changes to the menses where it can become irregular,  prolonged or more frequent.  It can also lead to liver dysfunction and blood clots (thrombosis) if used when contraindicated.

Pregnancy While on Jadelle:  Recently, we have seen an increase in women (both at our Auckland and Wellington Pregnancy Centres) who have had Jadelle inserted and now find themselves pregnant.  We also have had a number of phone calls from parents of young girls as well as women who have had the implants and are now wanting to have them removed early.  Many people talk of not having all the facts at the time of insertion.  It appears too, that women are not being screened properly for medications and conditions which might contraindicate its use.

It is advised by Bayer Health Care that Jadelle should be removed immediately if the woman becomes pregnant.

At Family Life International, we have a number of questions regarding the affect the hormones in Jadelle would have on a developing preborn child.  Will the hormones affect the child’s fertility later on in life?  Will the female hormones affect the developing child who is male?  Certainly, these children should be monitored post-birth and even into adulthood.

Controversy surrounding the Removal of Jadelle:  Late last year it was revealed that between the months of January to May 2012, there were seven incidents reported to the Centre for Adverse Reactions Monitoring in Dunedin, where it was difficult to remove or even locate the implants.

Even more worrying, was the assertion of Dr Christine Roke, medical advisor for the Family Planning Association, that the incidence of difficulties in removing the implant could be more frequent than indicated by the Centre for Adverse Reactions Monitoring.  “I think doctors in     practice often just get on with it and forget to report these things.”  She is reported by Stuff.co.nz to have said.

The Jadelle literature put out by Bayer Health Care assures users that the implants will not move around saying “They will remain under the skin where they are placed.  They are flexible and cannot break in your arm.  They will become naturally surrounded by a protective layer of fibrous

Clearly this assertion is not true.

One lady whom we are helping, had Jadelle inserted, and after nine months she came into our Wellington Pregnancy Centre for a pregnancy test. It was positive and after a scan, it was decided she was four months along. Considering the manufacturers’ warning to those who fall pregnant with the rods still in, she was advised immediately after the positive test to get it removed. Unfortunately there is a waiting list for removal, so she travelled to another FPA clinic to get it removed the following week. The doctor there, trained in removing Jadelle, was unsuccessful in removing the one rod visible to her. The expectant mother has now been informed by a second doctor that the rods must have fallen out and that the first doctor must have seen scar tissue. A blood test valued at $900 is available postpartum to ascertain whether or not the implant remains. Thankfully, according to the scan, baby is doing well. While trying to remain positive in the last trimester, there is still the worry of the unknown.

Clearly Jadelle’s safety and benefits for individual women should be questioned. The history of Norplant suggests that New Zealand should never have allowed this contraceptive device into the country, let alone made it free for our women. Women are clearly distressed and given the numbers we are seeing in our Centres, there are surely more out there whose stories have not yet been heard.

We believe at FLI that this method of contraception should be removed from the list of free ‘medicines’ and a greater campaign explaining the issues surrounding Jadelle’s use should be undertaken. –