Rebecca Sheriff, Trainee Solicitor
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Over the last 12 years, Implanon, the only subdermal contraceptive available in the UK, has been used by thousands of women.
The implant, a flexible plastic rod 4cm in length and 2mm in width, is inserted under the skin of the upper arm. It works by gradually releasing the hormone progesterone which stops the ovaries from releasing eggs and makes the womb less receptive to fertilised eggs. It provides protection against pregnancy for up to three years and properly inserted is 99.95% effective among all users.
Recent controversy surrounding the implant has arisen however as it has emerged that despite having the hormone filled rod inserted in their arms, a total of 584 women have reported unwanted pregnancies to the Medicines and Healthcare Regulatory Agency. Even more women have complained that they were left injured or scarred by the rod inserted into their arm and it is reported that the NHS has paid out compensation to women as a result. The total number of women affected could in fact be far higher as many women may not have complained after becoming pregnant and miscarrying, undergoing abortions or giving birth.
The Implanon implant is invisible to x-rays and, therefore, impossible to detect in the body without a CT scan and a blood test. Given that these are not routine tests carried out after the insertion of the implant, many women then go on to have sexual intercourse in the belief that they are protected from pregnancy having had an Implanon implant inserted.
Legal Issues arising From Implanon
Pregnancy
Whilst Implanon is considered very reliable, as with all other forms of contraception it is not 100% safe as a form of protection. Unfortunately, therefore, there is no legal basis for bringing a claim in the event that a woman becomes pregnant despite having an implant.
Where a potential claim may arise, however, is from non-insertion of the implant itself into the patient’s arm. Indeed investigations have shown and cases are currently being pursued where the implant was not in fact released from the pre-loaded applicator and, therefore, never inserted into the arm of the patient at all unbeknown to them. Proper insertion of the device, therefore, is the key issue here.
Those responsible for inserting the implant are recommended to ask the patient to feel for the implant after it has been inserted. Recent cases have shown, however, that in many cases patients do not know what they are feeling for or what their arm should feel like once the implant has been inserted. Furthermore, following the application of a local anaesthetic prior to insertion, many women claim that their arms felt swollen and so they assume, wrongly, that the implant had been successfully inserted. This begs the question, therefore, that should the responsibility for checking that the device has been inserted fall with the patient - a person, who in most cases has no prior experience or knowledge of how these devices feel under the skin.
Stephanie Prior, a Partner at London Bridge based firm Anthony Gold Solicitors has acted and continues to act for women who have suffered personal loss and injury as a result of the Implanon devices being wrongly inserted.
One previous client, whose claim has now settled, suffered psychological trauma after becoming pregnant and miscarrying. Tests later showed that the Implanon implant had never actually been inserted in her arm. In the same circumstances, another such client faced the difficult decision to terminate the pregnancy going against her religious beliefs causing her marriage to break down as a result. Other clients have continued with their pregnancies.
Since the issue surrounding the insertion of the Implanon implant came to the forefront last month, Stephanie has been inundated with new enquiries from the general public. Stephanie stated that ‘these cases are not about Implanon failing, they are about doctors failing to insert these devices properly. I have clients who fell pregnant as they were unaware that the Implanon device had not been inserted into their arm and they suffered psychological difficulties as a consequence of falling pregnant and later miscarrying or having to make the decision to terminate the pregnancy.’
Scarring & Nerve Damage
In other cases, removal of the Implanon implant has left some women with unsightly and raised scarring. It is, however, much harder to establish a claim for negligence in this area.
When an implant is inserted, one would normally expect the scar to be approximately two to three millimetres wide. When the implant is later removed, it is usually removed through the original scar. In some cases, however, patients are left with larger scars as those who attempt to remove it either struggle to find the implant as it has been inserted too deeply and/or into the muscle or they make larger incisions than necessary. The opinion of medical experts of late is that where a scar is larger than one to two centimetres there may very well be a claim for negligence.
Stephanie Prior is also currently representing a client who suffered extensive keloid scarring to her arm when the device was removed. This has caused her emotional distress and embarrassment as the scar is very unsightly.
In other and more extreme cases, if an Implanon implant has been inserted too deeply, it can cause significant nerve damage. In such cases, however, negligence is easier to establish. While there have been some reported cases of migration of an implant, deep insertion is generally accepted to be associated with poor insertion technique rather than migration of a properly inserted implant and, therefore, a claim for negligence may arise.
Training
It has also come to light during the recent controversy that the lack of training available to those health workers responsible for inserting the Implanon implant is also a contributing factor to the problems that have arisen.
Guidelines dictate that health workers must have a diploma to fit the hormone rod into a patient’s arm. NHS chiefs, however, are ignoring this to hit targets and to save costs. The Faculty of Sexual and Reproductive Healthcare has said that the money that was assigned by the government for contraceptive training in a three year program at the start of 2006 was in fact not used for that purpose.
GPs are often less experienced in the insertion of implants as this is generally carried out by Family Planning Clinics. There is, therefore, a higher burden on Family Planning Clinics given the qualifications and experience of the staff that are employed.
Health workers have, therefore, been inserting implants without the requisite training resulting in non-insertion, deep insertion, scarring and nerve damage. Stephanie Prior has also confirmed that training is a major factor in these cases.
Interactions With Other Medication
Anthony Gold Solicitors has also received numerous new enquiries from women who have had the implant correctly inserted but have fallen pregnant due to interaction of the Implanon implant with other medication that they were taking at the time of insertion to the full knowledge of the health worker that inserted it.
Particular medications that have been mentioned are ‘carbamazepine’ and ‘lamotrigine’ which have interacted with the hormone released by the Implanon implant rendering it ineffective and leaving them at an increased risk of pregnancy.
If a woman is prescribed the Implanon implant in such circumstances then a claim for negligence may very well be established with supportive expert evidence.
Bringing a Claim
As with all personal injury claims, to bring a claim for negligence in these such circumstances, there is a time limit of three years from the date of the incident or date of knowledge. In order to protect claims for non-insertion resulting in pregnancy, therefore, it is best to assume that the date of knowledge is the date when the woman first takes a pregnancy test as this is the date when they first realise that something is wrong and consider the possibility that they may be pregnant. By ensuring that the claim is issued within three years of this date, there is no argument for the defendant that the claim is out of time.
In order to bring a claim for negligence arising from any one of the circumstances above, a positive report from a Contraceptive and Reproductive Health Care expert is vital. Following this, a report of a Psychiatrist will also be essential in documenting the psychological effect that an unwanted pregnancy, miscarriage, abortion, scarring or nerve damage has had on the client.
Conclusion
In response to these concerns, the Implanon implant was withdrawn by the manufacturers in October 2010 and replaced with a newer version, Nexplanon. This has a new applicator designed to reduce insertion errors and is radiopaque so that it can be easily detected by x-ray or CT scan.
It is clear, however, from the number of women contacting Anthony Gold on a daily basis that the controversy and effects of the Implanon implant looks set to continue for some time to come.
Rebecca Sheriff is a Trainee Solicitor in Anthony Gold's personal injury department. She works closely with Stephanie Prior who is acting for a number of women who have been affected by the mis-insertion of the implanon contraceptive device. For further information email Stephanie Prior or call 020 7940 4000.
