Implanon and medical indemnity: a case study of risk management using the Australian Standard

The medical profession is increasingly accepting the need to incorporate risk-management strategies into medical practice. A variety of models have been used, including accreditation, systems review, and compliance with clinical pathways and guidelines. In this article, we describe the experience of applying a simple framework, the Australia and New Zealand Standard for Risk Management (AS/NZS 4360: 1999),1 to assess and “treat” risks in a staged manner. This standard was applied by the medical indemnity insurer MDA National to address and treat its potential exposure to litigation associated with the contraceptive implant Implanon (Organon). Other medical indemnity insurers have responded to this issue in a range of ways, which have varied over time.

MDA National’s initial response was cost-containment (prudential risk management). Its second response of applying the Risk Management Standard to manage clinical risk allowed it to reinstate Implanon treatment to the general practice non-procedural category for indemnity insurance purposes.

Implanon is a progestogen-only implant that acts as a long-term (3-year) contraceptive. In clinical trials it demonstrated a lower failure rate than existing forms of contraception, such as the oral contraceptive pill and barrier methods.2-4 It was released in Australia in May 2001. Factors such as convenience, low cost to patients and the apparent low failure rate made it attractive to many Australian women, and uptake was rapid.

The manufacturer, Organon, in conjunction with Family Planning Australia and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, developed a training program for medical practitioners. This information was also available on CD-ROM and video for remote and rural practitioners. The training sessions appear to have focused on teaching practitioners how to insert the implant, with practice on a manikin, and did not fully explore the problems that could arise when the implant was used in clinical practice.

The sessions had a high attendance rate by general practitioners (GPs), who were keen to learn the technique of insertion, but many still reported problems with clinical use. The implant is supplied with an applicator that appears similar to a syringe, with a cannula and obturator (“plunger”). However, the technique of insertion is the opposite to that used with a syringe, as the obturator remains fixed while the cannula is withdrawn. Many practitioners who attended training sessions reported that this counterintuitive action was not easily mastered. In addition, the implant and obturator used in the training sessions contrasted in colour (blue and white, respectively), while those supplied in the commercial product were both white. This was extremely confusing for some practitioners when they first used the implant clinically. Further, there was little emphasis in the training sessions on the disclosure of risk and the need to adequately document the process and procedure.

Medical practitioners are required by their medical indemnity insurers to report any incident or adverse outcome that may give rise to a claim. These data are regularly reviewed by insurers to detect any trends. In June 2002, 13 months after the release of Implanon, a disturbing pattern became obvious to MDA National. Discussions with the manufacturer confirmed that the trend had been recorded by other indemnity insurers. Not since the introduction of laparoscopic surgery had indemnity insurers experienced so many incident notifications with a new technique.

Patients had selected a particular form of contraception that offered a low failure rate, but this had not been achieved, resulting in unintended pregnancies — almost 100 in the first 18 months after release (Organon [Australia] Pty Ltd. Implanon non insertion: extent of the issues and risk management strategies. Discussion paper submitted to MDA National, November 2002 [unpublished data]). The reasons for this were not always clear, but possibilities included failure to insert the implant, incorrect timing of the insertion, and implant failure, possibly, in some instances, because of interactions with other medications.

A proportion of the unintended pregnancies resulted from failure to recognise that the implant had not been inserted. The implant could be difficult to palpate if inserted deeper than the subdermal layer or if the area was swollen. Consequently, some patients remained fertile when they assumed they had adequate contraception. In some cases, pregnancies were reported over a year after patients had attended for insertion.

Some incident reports claimed that the implant was present but had “migrated” in the arm. Confirming presence of the implant is difficult. As it is not radio-opaque, it cannot be detected by x-ray. It can sometimes be identified by ultrasound examination, but this service is not readily available to remote and isolated patients and has cost implications. If the implant cannot be found by ultrasound examination, a blood test can confirm its presence. However, this test can only be performed by the manufacturer in Europe.

Other notifications related to difficult removal of the implant, resulting in scarring. Some patients required general anaesthesia for its removal.

MDA National’s risk management committee reviewed the notifications and recognised that the potential costs of litigation required some intervention. The level of reported incidents paralleled the rapid uptake of the implant. The manufacturer modified the training program and released further information on the need for both doctor and patient to palpate the implant and document its presence after insertion (the manufacturer provided a sticker for doctor and patient to sign and put in the medical record). The problem of spiralling adverse incidents was reported in the medical press,5 but raising awareness alone was not sufficient to reduce the problem.

At the time of our initial review of the Implanon incidents, the High Court decision in the Cattanach v Melchior case for wrongful birth6,7 had not been handed down. The success of a claim for the cost of raising a healthy child meant that the potential cost of any unintended pregnancy claim could be high. While some states have changed legislation to prevent this type of claim, this is not yet national policy. Any claims lodged before these legislative changes will be heard in the light of the High Court decision.

MDA National’s response was in two stages: the initial response to contain the potential costs to the company, and the second to manage the clinical risk associated with the device.

The Standard for Risk Management (AS/NZS 4360: 1999) proved a useful tool to risk-assess and treat the problems that arose with the release of Implanon. It provides for ongoing review and monitoring of the proposed risk-management strategies. The Implanon story exemplifies an opportunity lost for risk assessment of a device in the clinical setting. A major intervention was required to halt the incidents. In future, a full risk assessment of the clinical implementation of a new product should be undertaken before its release. This would identify the risk barriers needed to minimise adverse incidents. If this had been undertaken, the one-year moratorium imposed on non-procedural general practitioners by MDA National might have been avoided.

The Royal Australasian College of Surgeons has established the Australian Safety and Efficacy Register of New Interventional Surgical Procedures (ASERNIP-S) to review new procedures and high-risk techniques.8 General practice has relied on licensing bodies, in this case the Therapeutic Goods Administration, to determine the safety and efficacy of drugs and devices. While this body approves products, it does not evaluate the potential risks in delivering the treatment. Ideally, manufacturers and medical indemnity insurers would refer new products, techniques and treatments identified as high-risk to the Royal Australian College of General Practitioners, which has the experience and skills to set standards and provide guidelines for general practitioners.9