LLR Policy for the use of Surgical Biological Mesh

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Category

Threshold Criteria

Acellular dermal matrices is an established medical device used for a variety of surgical interventions in the UK with improved outcomes for patients. There is a significant body of evidence that biological meshes can significantly improve aesthetic outcomes and expand indications for breast reconstruction and result in greater, reduced capsular contraction and greater patient satisfaction after surgery.

Eligibility

LLR ICB will only funded when the following criteria is met for BREAST RECONSTRUCTION SURGERY
 
– Patients with cancer of the breast, ductal carcinoma insitu and those who are identified as having high risk genes e.g. BRCA 1/ 2, TP53, PTEN
AND
– Patient has adequate skin envelope to reduce risk of skin necrosis
 
Regular audit of patients undergoing breast reconstruction with use of biological mesh as recommended by the joint guidelines from ABS and BAPRAS. Absolute requirement is implant loss of <10%
LLR ICB will NOT fund the use of biological mesh in the following patients
 
– Patients who have previously had chest radiotherapy
– Patients who are currently smoking
The ICB advise caution in the following situations
 
– Patients with a BMI of > 30
– Breast size greater than 600mg (increased risk of infection)
– Patients with poorly controlled diabetes
LLR ICB  will only funded when the following criteria is met for PARA OESOPHAGEAL HERNIA REPAIR
 
Patient has large gaps in the diaphragm which are not amenable to simple surgical repair
Biological Mesh is NOT commissioned for
– Thoracic surgery
– APER/ eLAPE
– Hernia repair other than the above
– Any other indications

Guidance

 
– Evaluation of Acellular Dermal Matrix Efficacy in Prosthesis-Based Breast Reconstruction
Plast Reconstr Surg . 2018 Mar;141(3):541-549. doi: 10.1097/PRS.0000000000004109.
 
– Bovine Acellular Dermal Matrix in Immediate Breast Reconstruction: A Retrospective, Observational Study with SurgiMend
Plast Reconstr Surg . 2018 Jan;141(1):1e-10e. doi: 10.1097/PRS.0000000000003982
 
– Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients
Plast Reconstr Surg Glob Open. 2022 Apr 14;10(4):e4258.
doi: 10.1097/GOX.0000000000004258. eCollection 2022 Apr.
 
– Novel three-dimensional acellular dermal matrix for prepectoral breast reconstruction: First year in review with BRAXON® Fast
Front Surg. 2022 Sep 5:9:970053. doi: 10.3389/fsurg.2022.970053. eCollection 2022.
 
– Acellular dermis-assisted prosthetic breast reconstruction: a systematic and critical review of efficacy and associated morbidity
Plast Reconstr Surg. 2011 Dec;128(6):1162-1169. doi: 10.1097/PRS.0b013e318230c29e.
 
– Safety Profile and Predictors of Aesthetic Outcomes After Prepectoral Breast Reconstruction With Meshed Acellular Dermal Matrix
Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S585-S592. doi: 10.1097/SAP.0000000000002764.
 
– Immediate direct-to-implant breast reconstruction with acellular dermal matrix: Evaluation of complications and safety
Breast.  2021 Dec:60:192-198. doi: 10.1016/j.breast.2021.10.006. Epub 2021 Oct 15.
 
– Acellular dermal matrices as an adjunct to implant breast reconstruction: Analysis of outcomes and complications
Eur J Surg Oncol. 2020 Apr;46(4 Pt A):511-515.  doi: 10.1016/j.ejso.2019.10.042. Epub 2019 Nov 1.
 
– Updated Evidence of Acellular Dermal Matrix Use for Implant-Based Breast Reconstruction: A Meta-analysis
Ann Surg Oncol. 2016 Feb;23(2):600-10. doi: 10.1245/s10434-015-4873-9.
 
– Prepectoral Direct-To-Implant One-Stage Reconstruction With ADMs: Safety and Outcome in “Thin Patients”
Clin Breast Cancer. 2023 Dec;23(8):e507-e514.  doi: 10.1016/j.clbc.2023.08.007. Epub 2023 Aug 25.
 
– Pre-pectoral breast reconstruction with tissue expander entirely covered by acellular dermal matrix: feasibility, safety and histological features resulting from the first 64 procedures
Gland Surg. 2024 Mar 27;13(3):297-306. doi: 10.21037/gs-23-432. Epub 2024 Mar 22.

– Mavros, M., Athanasiou, S., Alexiou, V., Mitsikostas, P., Peppas, G. and Falagas, M (2011) Risk Factors for Mesh-related Infections After Hernia Repair Surgery: A Meta-analysis of Cohort Studies, World Journal of Surgery, Vol 11, pp. 2389-2398.
 
ARP 90 Review Date: 2027

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