Use of Banned Synthetic Mesh for Pelvic Organ Prolapse
Sandwell and West Birmingham Hospital NHS Trust (‘the Trust’) has written to patients of Consultant Uro-gynaecologist, Mr Angamuthu Arunkalaivanan regarding their treatment for pelvic organ prolapse (‘POP’). . This is after concerns were raised about patient safety.
In January 2009, The Trust decided to stop implanting synthetic mesh as a first surgical treatment to repair POP. This was in accordance with national government guidance from the National Institute for Health and Care Excellence (NICE) following concerns with the long term effectiveness of this type of treatment. Many other hospital trusts had also taken this action. However the despite the Trust’s decision to stop offering mesh treatment, Mr Arunkalaivanan continued to perform this type of operation.
The Trust is in the process of reviewing all mesh operations carried out by Mr Arunkalaivanan. This review will check whether patients received reasonable treatment, including whether their surgery was appropriate and properly undertaken and also to check whether patients undergoing this surgery were provided with all the necessary information to make an informed decision about the procedure.
Who is Mr Arunkalaivanan?
Mr Angamuthu Shenbagavalli Arunkalaivanan was a Consultant Uro-gynaecologist based at Birmingham City Hospital. He also worked privately for BMI Healthcare at the Edgbaston Hospital and the Priory Hospital in the West Midlands. Mr Arunkalaivanan is registered with the General Medical Council (GMC) as a specialist in Obstetrics and gynaecology, however since February 2015 he does not have a license to practise. This means that he is currently unable to practise as a doctor in the UK.
In 2013 Mr Arunkalaivanan was referred to the GMC, the regulatory body for medical practitioners in the UK, for an allegedly inappropriate breast examination. The GMC found that Mr Arunkalaivanan’s actions were sexually motivated and that his fitness to practise was impaired. As a result he was suspended from practising medicine.
In 2014 Mr Arunkalaivanan successfully appealed this decision and his impairment and suspension were overturned by a judge. This allowed him to return to work as a doctor.
What are the concerns about synthetic mesh?
The use of mesh to treat POP is controversial. This is because there is very little information on the long-term benefits and complications of using synthetic mesh. Despite this, the use of mesh has been widely used in to clinical practice. There are various groups across the UK that campaign for the use, safety and efficacy of transvaginal mesh implants to be reviewed.
There are different types of mesh available to doctors. The safety and effectiveness of the procedure varies according to which mesh is used.
Some of the complications of using synthetic mesh can be significant. The Medicines and Healthcare products Regulatory Agency have had a number of patients who have had synthetic mesh contact them regarding serious post-operative issues they have suffered. The most common problems of patients who have undergone synthetic mesh procedures include:
- Post-operative pain or irritation
- Sexual difficulties
- Mesh erosion – when the mesh pushes through the vaginal wall, causing pain and irritation. In serious cases, the mesh can erode internal organs, such as the bladder or bowel.
- Infections or abnormal discharge
- Incontinence – an unintentional passing or urine
- Further operations
- Organ perforation
- Fistula – an abnormal passage between two organs, which can cause an infection or discharge
- Recurrent prolapse
There have also been problems reported worldwide with the use of synthetic mesh for POP. In the United States, there have been successful legal claims for compensation for failing to inform women of the associated risks. Legal action has also been taken in Australia by women who suffered side effects.
In order to assist medical practitioners, NICE has produced guidance about the use of vaginal mesh. This recommends that clinicians who want to treat POP with vaginal mesh should:
- Inform the clinical governance leads in their hospital trust of their intention to treat patients using vaginal mesh;
- Make sure that their patients understand the risk of complications and that long-term effectiveness is not certain;
- Provide patients with clear written information about the procedure. In addition, NICE’s ‘Information for Public – Treating vaginal wall prolapse with surgery using mesh’ leaflet should be given to the patient.
- Audit and review all patients who choose to use mesh to repair vaginal wall prolapse.
The use of synthetic mesh should therefore only be carried out where special arrangements have been made, informed consent has been obtained, and there is provision for auditing and/or researching patient outcomes.
Why is synthetic mesh still used?
The main benefit of using synthetic mesh is that it has a better success rate when compared to other traditional surgical repairs. The chance of developing complications is relatively low and the majority of women will not experience post-operative problems. The risks should be fully explained including the fact that the long-term effects are unknown and removing the mesh involves complex surgery. It is important that the procedure is carried out by a gynaecologist who specialises in POP.
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Where mesh repair is successful, and you are not experiencing any problems, it is safe to leave the mesh in place.
Have you been contacted?
It is concerning that despite being banned; synthetic mesh was still used by the Sandwell and West Birmingham Hospitals NHS Trust.
If you underwent a mesh repair for POP by Mr Arunkalaivanan, you may understandably be concerned about the treatment you received. You may feel even more anxious if the procedure has not been successful and you are suffering from complications. If this is the case, you may have a claim for medical negligence and be entitled to compensation for your injuries. If you are worried, you should seek legal advice from a specialist about whether you have a claim.