The Royal College of Surgeons has recently produced a statement calling for greater regulation of medical devices.

An investigation carried out by a combination of over 50 media organisations including the International Consortium of Investigative Journalists, the BBC, the Guardian and the British Medical Journal has identified that medical devices and implants are being put into patients even if they have failed clinical trials or have undergone minimal or no clinical testing.

The investigation has apparently uncovered data showing a rising number of malfunctions and injuries caused by medical devices.

The Royal College of Surgeons have highlighted that using medical devices without clinical data poses a risk to patient safety and public confidence.

The President of the Royal College of Surgeons, Derek Alderson has stated:

The RCS believes that all new surgical procedures and devices should be registered, with related data collected in the appropriate national audits, before they are routinely offered to patients. All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term. This requires Government funding and support, and potentially national guidelines on the introduction of new procedures and technologies.”

 Examples of defective products

  •  Heart pacemakers
  •  Birth control implants
  •  Mesh implants
  •  PIP breast implants
  •  Implantable defibrillators
  •  Gastric bands

Our expertise

Freeths solicitors have considerable experience with product claims. We have successfully secured life changing compensation for those affected by defective products.

The Product Liability team is headed by Consultant Paul Balen. He has represented claimants at every level of the English and European courts and continues to advise clients with faulty breast and other implants, faulty heart pace makers and other medical products such as gastric bands.

Paul is on the steering committee for PIP Breast Implants, dealing with outstanding claims including the current attempt by the insurers of one defendant to appeal to the Supreme Court.

Paul Balen’s profile can be found at -

Defective Heater Cooler Machines

Freeths currently represents 19 patients (or their families) in claims against the manufacturer of a defective heater-cooler unit (HCU).

The defective HCU was used during cardiac surgery and this resulted in the patients contracting an infection known as Mycobacterium Chimaera

A number of the patients affected have died from the infection and those who are still living are now undergoing rigorous treatment regimens with life changing side effects.

New cases are still emerging. 

For more information about the defective heater-cooler units and Mycobacterium Chimaera, please use the following link: 

Contact us

Our expert solicitors can help you if you believe you have been injured by a medical device. Our specialist team will be able to help you claim financial compensation for the injuries and losses you have suffered as a result.

If you think you may have been injured by a medical device, please contact James Cavanagh on or 01865 781 193 for a free, informal discussion.

Freeths’ Product Liability team is led by:

Paul Balen, Consultant (Nottingham) on 0845 050 3289

For further information please also visit our website at: