The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Insertion of an annular disc implant at lumbar discectomy, in November 2014.
March 2022: The device used in this procedure no longer has a current CE mark. The CE mark is necessary for medical devices to be marketed in the European Union. A non CE marked device can only be used in the context of clinical investigations with MHRA and research ethical approval.
Lumbar disc herniation occurs when the nucleus pulposus of an intervertebral disc protrudes through a tear in the surrounding annulus fibrosus. Symptoms include pain in the back or leg, and numbness or weakness in the leg. Serious neurological sequelae may sometimes occur.
Conservative treatments include analgesics, non-steroidal anti-inflammatory medication and physical therapy. Epidural corticosteroid injections can also be used to reduce nerve pain in the short term. Lumbar discectomy is considered if there is evidence of severe nerve compression or persistent symptoms that are unresponsive to conservative treatment. Surgical techniques include open discectomy or minimally invasive alternatives using percutaneous approaches.
Lumbar discectomy usually leaves a hole in the annulus fibrosus through which the nucleus herniated, which may lead to reherniation and progressive loss in disc height.
V33.8 Other specified primary excision of lumbar intervertebral disc
V55.- Levels of spine
Y36.8 Other specified introduction of non-removable material into organ NOC
Note: Codes within category V55.- are assigned in second place each time a spinal operation is coded. If the levels of spine are not specified V55.9 Unspecified levels of spine is used.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.