We are also aware that the most commonly used implant device has recently been updated to make its insertion simpler and to allow it to be more easily located should it become lost, which it is hoped will lead to fewer problems in the future.
(Vocus/PRWEB) 21 March 2011
The MDU is asking its GP members fitting women with contraceptive implant devices to ensure they are properly trained to carry out the procedure and hold a letter of competence from the Faculty of Sexual and Reproductive Healthcare, or equivalent proof of suitable training.
The announcement came as the MDU revealed it had seen a small increase in negligence claims over the last year alleging a problem with single rod implant devices. While the MDU, which indemnifies over 50 per cent of UK GPs, was notified of just 29 claims over the last 10 years alleging a problem with single rod implant devices, it has been alerted to six cases in the last year alone. In the previous nine years it was notified of between one and four cases a year.
Dr Rupert Lee, MDU clinical risk manger, said:
“Some of the increase in claims we have seen may be due to the higher profile contraceptive implant problems have received recently in the media. Recent news reports suggest the NHS has received over 1,000 complaints and has paid out £200,000 in compensation in the most serious cases.(1)
“Although the cases notified to the MDU are few, given that more than one million contraceptive implant devices have been sold in the UK since 1999(2), in our experience some of the difficulties could be avoided through adequate training and good communication with patients. Patients should understand the risks and benefits of the device, for example.
“We are also aware that the most commonly used implant device has recently been updated to make its insertion simpler and to allow it to be more easily located should it become lost, which it is hoped will lead to fewer problems in the future.”
The majority of claims alleged a failure to prevent pregnancy, with concerns that the device may not have been inserted properly often a feature. The MDU has paid out over £100,000 in total to settle six of the claims and the remaining cases have either been discontinued by the claimant or are still ongoing. The highest compensation paid was £30,000 for an unwanted pregnancy.
The main reasons for allegations being made against MDU GPs were:
- Pregnancy: 11 (38%)
- Insertion problem: 8 (28%)
- Removal problem (including nerve damage, scarring): 6 (21%)
- Problems locating after insertion: 3 (10%)
- Side effect: 1 (3%)
The MDU has issued the following advice to GPs fitting contraceptive implants:
- Ensure you are specifically trained and competent in carrying out the procedure. This will usually include an initial period of supervision by a trainer to check the correct insertion and removal techniques are followed. The MDU stipulates that, in order to be indemnified, members need a signed certificate of competence from an accrediting body such as the Faculty of Sexual and Reproductive Healthcare (FSRH), or an equivalent demonstration of suitable expertise and competence.(3)
- Provide patients with full information about the risks and benefits of and alternatives to the implant, including the failure rate and risk of complications at insertion and removal. This discussion, which should be noted in the records, could also be backed up by patient information leaflets.
- Ensure appropriate follow-up arrangements are in place for all patients using contraceptive implants.
- Consider and rule out the possibility of a uterine or ectopic pregnancy in patients using a contraceptive implant, who present with symptoms which could indicate pregnancy.
- Consider specialist referral sooner rather than later if location or removal problems are encountered.
- Carefully record product details, batch numbers and expiry dates in the patient records.
- Have an adverse incident reporting system in place so the practice can analyse and learn from any mistakes or near misses that occur.
- Explain and apologise to patients if things go wrong and ensure that you take steps to deal with the consequences and arrange appropriate treatment and follow up.
1. Women win £200,000 payout over pill implant pregnancies, Telegraph, 25 January 2011
2. Implanon contraceptive implant: Information for women and healthcare professionals, Medicines and Healthcare Product regulatory Agency (MHRA), 5 January 2011
3. The FSRH and the Royal College of General Practitioners are working together to seek accredited alternative routes to allow GPs to demonstrate their competence in the field of contraception, including fitting long acting reversible contraception (LARCs).
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