​Global withdrawal of glaucoma stent after study reveals problems within five years

The CyPass Micro-Stent is essentially a small tube containing tiny holes, which is surgically implanted in the eye and is designed to drain fluid that causes high eye pressure and vision loss in people with glaucoma. 

The device was launched in the UK and the EU in April 2017, and approved by NICE for use on the NHS in February 2018. 

Alcon, the producer of the device, and division of multinational healthcare giant Novartis, announced a voluntary global withdrawal of the device on 29 August 2018. In the United States, this was upgraded to a Class 1 Recall on 24 October 2018. 

According to communications released by Alcon, the withdrawal was triggered by the results of a post-market study into the long term safety of the device. Alcon have accepted that patients in that study who were implanted with the device, “experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone”. The FDA has further clarified that, “27.2 % of implanted patients had more than 30% loss in endothelial cell density”.

Alcon have written to treating clinicians in the UK confirming that they should cease using the device, and setting out the steps that should be taken to monitor those patients that are affected. 

The Royal College of Ophthalmologists has commented in response to the product withdrawal that, “At this point there is no more detailed data and there has not been any suggestion that patients have suffered permanent corneal damage, lost vision or experienced other serious effects. In addition, it is not certain whether this may relate to all devices or to device position. Further uncertainties include whether it is appropriate or justified to remove devices already implanted, which carries risks, or what the exact long term risks are for patients”.

Gene Matthews, partner in the Consumer Law & Product Safety Department at Leigh Day commented:

“Following the revelations of The Implant Files international exposé, we now see yet another example of a device being launched worldwide, only to discover safety concerns once it is already on the market. A better way must be found to allow innovation to occur without patients effectively being used as test subjects.” 

Stuart Warmington, a solicitor in the Consumer Law & Product Safety Department added:

“We know from documents published in the US that individuals were enrolled onto a pre-market study for this device from as early as 2009. Affected patients will no doubt question whether Alcon could have done more to identify these ‘5 year’ safety issues months or years ago.”

If you have been affected by the withdrawal of the CyPass Micro-Stent and would like to discuss the matter with one of our specialist solicitors please do not hesitate to contact Stuart Warmington by emailing swarmington@leighday.co.uk or call 0207 650 1187.