title: The manufacture of generic replicas of implants for arthroplasty of the hip and knee: is it regulated and will it save money?
abstract: Joint replacement of the hip and knee remain very satisfactory operations. They are, however, expensive. The actual manufacturing of the implant represents only 30% of the final cost, while sales and marketing represent 40%. Recently, the patents on many well established and successful implants have expired. Companies have started producing and distributing implants that purport to replicate existing implants with good long-term results. The aims of this paper are to assess the legality, the monitoring and cost saving implications of such generic implants. We also assess how this might affect the traditional orthopaedic implant companies. Cite this article: Bone Joint J 2016;98-B:892-900.
authors.affiliation: West Suffolk Hospital, Hardwick Ln, Bury St Edmunds, Suffolk, IP33 2QZ, UK.
authors.forename: A
authors.initials: A
authors.lastname: Atrey
authors.affiliation: University Hospital Antwerp, Antwesp, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Heylen
authors.affiliation: South West Deanery, UK.
authors.forename: O
authors.initials: O
authors.lastname: Gosling
authors.affiliation: West Suffolk Hospital, Hardwick Ln, Bury St Edmunds, Suffolk, IP33 2QZ, UK.
authors.forename: M J L
authors.initials: MJ
authors.lastname: Porteous
authors.affiliation: University College London Hospitals, 235 Euston Road, London, NW1 2BU, UK.
authors.forename: F S
authors.initials: FS
authors.lastname: Haddad
mesh_terms: D019644:Arthroplasty, Replacement, Hip; D019645:Arthroplasty, Replacement, Knee; D017046:Cost Savings; D005060:Europe; D006622:Hip Prosthesis / Q000191:economics*; D006801:Humans; D007720:Knee Prosthesis / Q000191:economics*; D062307:Medical Device Legislation; D010330:Patents as Topic; D011474:Prosthesis Design; D014481:United States
keywords: Generic total hip arthroplasty; Generic total knee arthroplasty; Generics; Implants; Replica