Botched Medical Implant Procedure Leads To Large Compensation Claim


The Law Of… Testing Medical Implants Properly

A shoulder injury while serving in the Royal Navy led to one ex-sailor being fitted with an untested medical implant. Sarah Holdsworth, a Medical Negligence Associate with Simpson Millar, details a case where a lack of informed consent led to ongoing issues, considerable pain and an eventual financial settlement.

Why Was A Medical Implant Necessary?

Laura Cooper joined the Royal Navy as a mechanic and moved into communications before a rock climbing accident put an end to her naval career. She was medically discharged in 2000 after sustaining an acromioclavicular injury to her left shoulder and spent the next 7 years in discomfort, which affected her ability to both work and look after her children.

By 2007 the problem had worsened considerably, culminating in a corrective procedure in 2011 that resulted in the eventual medical negligence claim.

Surgical Procedure Leads To Unbearable Pain

Referred to the Royal National Orthopaedic Hospital in Stanmore, Ms Cooper agreed to a shoulder replacement on the advice of the trust's Consultant Orthopaedic Surgeon. The procedure was intended to repair the damage and alleviate her symptoms by inserting a Polyether ether ketone (PEEK) implant.

Instead of bringing much sought after relief, the operation only aggravated the issue further, increasing the amount of discomfort Ms Cooper was suffering and reducing the mobility in her shoulder. There followed a succession of visits to A&E, the pain having become unbearable, which led to an examination under anaesthetic and subsequent treatments including further invasive surgery.

By 2013 a total shoulder replacement was needed, a procedure that revealed the initial medical implant had failed to integrate with the bone. Even after the total replacement and a further revision, Ms Cooper continued to endure a significant amount of pain, with the former service member having since been diagnosed with complex regional pain syndrome (CRPS).

Exploring the possibility of making a claim for the ordeal she'd been through, Ms Cooper approached Simpson Millar and Sarah Holdsworth took on the case.

A 'Novel' Material

The key finding that led to the assertion that medical negligence had taken place was quickly discovered in Ms Cooper's medical records. Examination of them revealed that the PEEK implant used in the initial procedure was made from what is referred to as a 'novel' material. Meaning it was unique and its use in medical implants unknown.

This led to the conclusion that the material, and the product into which it had been incorporated, had not undergone the necessary level of testing. A fact backed up by the unearthing of a call for funding to test the product on animals, made after Ms Cooper's surgery.

Allegations Of Medical Negligence

From the discovery regarding the 'novel' material and further conversation with Laura Cooper, it became clear that she had not been given the full facts at her initial consultation. Had she known of the risks that undergoing an untested medical implant procedure would entail, Ms Cooper would have rejected the product in favour of one that had an established track record.

The allegations regarding a lack of informed consent put to the Royal National Orthopaedic Hospital Trust were:

  • Ms Cooper was not made aware of the material facts and risks in relation to the proposed procedure
  • She was not advised of any reasonable alternatives.

It was also contended that had an established medical implant been used, the procedure would have been successful and Ms Cooper would have experienced improved mobility, function and reduced pain in her shoulder.

The Royal College Of Surgeons Investigates

Following its receipt of a Letter of Claim, which detailed the alleged negligence, the Royal National Orthopaedic Hospital denied liability for Ms Cooper's issues. With court proceedings looking ever more certain, a breakthrough was reached when the Royal College of Surgeons became involved.

The resulting investigation into the Consultant Surgeon who had treated Ms Cooper and his use of the untested PEEK implant found:

  • The implant had not been subject to sufficient governance or approval processes prior to being made available to the claimant
  • The consent form was not acceptable as it indicated a routine joint replacement was being undertaken, which this was not
  • There was no evidence of the Consultant Surgeon having discussed the procedure personally with Ms Cooper
  • Another patient who had undergone the same procedure had developed synovitis, after which the Consultant Surgeon's use of the medical implant was halted along with its manufacture due to insurance issues
  • The Consultant Surgeon had fitted 20 other patients with the same medical implant in identical procedures. Out of these, 12 had undergone revision surgery, with 1 scheduled for further revision, and 4 more were under review for a possible revision.

Out Of Court Settlement

The Royal College's report brought about an admission of liability from the hospital trust and it was agreed that it had failed in its duty of care to Ms Cooper. Shortly afterwards an out of court settlement of £60,000 was reached.

Following her successful compensation claim, Ms Cooper said:

"If not for Sarah Holdsworth, I would never have found out I was used as guinea pig by the Royal National Orthopaedic Hospital. I can't thank Simpson Millar enough, and particularly Sarah, for how they handled my complicated negligence case."

"I was very happy with the outcome, as what I received was a lot more than I originally expected. Sarah treated me and my claim with empathy and understanding and I cannot think of anyone I'd rather have had deal with it."

"Thank you Simpson Millar and, more importantly, thank you Sarah Holdsworth."

If you think you have been the victim of medical negligence, you may be entitled to compensation. To find out if you have a case, contact Simpson Millar today.

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