The mesh, which has been used to treat urinary incontinence (most commonly after childbirth) and pelvic organ prolapse was recorded by NICE on their website as having “serious but well-recognised safety concerns”. The scale of defective devices is not yet known but it is thought that vaginal mesh has been used for approximately 10,000 patients each year for the past 10 years. Unfortunately those devices which are defective have caused significant and in some cases permanent injury to patients. The recognised risk of complication is said to be 3-5%, however some studies have found risk to be in the region of 10-15%

A draft consultation by NICE, published at the end of 2017, recommended that the mesh should only be used by experienced surgeons trained in laparoscopic urogynaecology and recommended that it be used primarily for research purposes, recommending that further research be undertaken.  The final recommendations from NICE are awaited.

Key issues

One area that the newly announced Government audit will focus on is the extent to which the devices were approved and used without clinical trial. Whilst the outcome of the audit will not be known until April, there are three key issues to consider:

  1. The use of clinical trials - It is paramount for Insurers to consider the risks associated with writing a policy which will encompass the use of a product where the extent of any trials undertaken by the manufacturer are not apparent. It remains important for manufacturers to properly consider and evidence whether a clinical trial is required and if not, why not, and for hospitals and doctors to consider the level of scrutiny that has been applied to any products that they are proposing on using in the treatment of patients. 
  2. Training and Consent - Clinicians should be aware of the limitations of any products, or the extent of testing of a product, before consenting a patient for its use.  Insurers may want to consider the wording of their policies in respect of both the qualifications of treating clinicians and whether any specific consent is required from a patient.
  3. The effect of a product recall - Considerations include not only the potential risks for patients but also the extent to which products should be withdrawn in the event of a defect. This comes against a background of NICE calling for vaginal mesh operations to be banned in the UK (November 2017) and following Johnson & Johnson’s withdrawal of their vaginal mesh device in Australia earlier this month.  The latter  is currently the subject of a class action.

How Capsticks can help

Capsticks have a dedicated team of insurance specialists who can assist with any matters that arise in relation to potentially defective products and advise in respect of clinical trials and product liability issues.

To find out more about out services, please visit our website or contact Majid Hassan, Ed Mellor or Lucy Wheeler.