The Spine Society of Australia (the SSA) notes that the Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd for the alleged unlawful supply of the INFUSE® Bone Graft Kit (the Kit).
It may assist members to be reminded of a brief (and not complete) overview of the history of this product in Australia.
The TGA had previously approved a medical device named as the Infuse Bone Graft/LT-Cage – Graft kit, spinal fusion (the Device). The Device comprised two parts, the Kit and a metallic spinal infusion cage (the LT-Cage). The relevant components of the Kit were – a recombinant human bone morphogenetic protein solution (rhBMP-2) and a collagen sponge carrier for the rhBMP-2 to adhere to and subsequently result in the formation of bone.
INFUSE® Bone Graft was approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in spinal fusion. INFUSE® Bone Graft was initially used in Australia under the TGA’s Special Access Scheme. Later, in 2005, the Device was approved by the TGA for use in spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4 – S1. The Device received a listing on the ARTG, the Australian Register of Therapeutic Goods as a two component Medical Device and was available for use in Australia in the public system.
To gain funding under private health insurance, a review was conducted by the Prostheses List Advisory Committee (PLAC) for listing on the Prosthesis List (PL) so that patients receiving the Device could be reimbursed under their private health insurance. Insurers are legally obliged under the Private Health Insurance Act 2007 and the Private Health Insurance (Prostheses) Rules to fund surgically implanted medical devices that are on the PL and are received by patients with appropriate levels of cover, in the course of a hospital admission that is associated with an appropriate MBS spinal item number.
However, the Device (the Kit & the LT-Cage) in its entirety was not listed on the PL. Only the Kit, INFUSE® Bone Graft, was added to the PL listing under orthopaedic medical devices. It was not listed on the PL in association with any interbody cage or device. Consequently, a discrepancy arose between the entry on the ARTG and the PL.
INFUSE® Bone Graft rapidly gained acceptance by spine surgeons in Australia and its use was expanded to other general orthopaedic procedures. The product was marketed by Medtronic and reimbursed by health funds without limitation in relation to type of surgery, level of the spine, associated cage or implant or clinical indication.
Spine surgeons used INFUSE® Bone Graft as a bone substitute but were able to use their preferred interbody cage, rather than the LT-Cage supplied by Medtronic. By the time the Device received TGA approval in Australia, the LT-Cage was essentially obsolete.
Subsequently, Medtronic supplied INFUSE® Bone Graft Kit to hospitals for use by Australian surgeons and we understand that eventually Medtronic stopped stocking the LT-Cage with the Kit. In early 2020, this was brought to the attention of the TGA by Private Healthcare Australia (PHA), who represent the for-profit health funds. As you are aware, subsequent to this, INFUSE® Bone Graft has been withdrawn from the Australian market.
Despite the PHA making disingenuous attempts at scare mongering by dredging up historical allegations over safety, the withdrawal of INFUSE® Bone Graft from the market in Australia was predicated by the regulatory issues that are now the subject of the TGA action. The TGA is alleging that the supply of INFUSE® Bone Graft was unlawful as the Kit was only registered to be supplied in conjunction with the LT-Cage.
From the surgeon’s perspective, we were using INFUSE® Bone Graft, a product that we had been led to believe by Medtronic had TGA approval and had been added to the PL for reimbursement without qualification regarding its use in a particular procedure or with a particular prosthesis. Further, the evidence in the literature supported its use as state of the art clinical practice as a bone substitute for obtaining bony fusion.
This will inevitably attract media attention and our members may have patients who have received INFUSE® Bone Graft contact them. The Department of Health’s website makes it clear that the TGA is not suggesting any wrongdoing by surgeons or hospitals in the use and supply of INFUSE® Bone Graft:
The TGA’s investigations are into Medtronic’s alleged unlawful supply of the Kit to hospitals.
The TGA is not alleging any wrongdoing by hospitals or clinicians.
If you are a consumer and have questions about the Kit, you should speak to your treating doctor in the first instance. If you, or your treating doctor, wish to report a problem or side effect of the Infuse Bone Graft Kit please visit the TGA website: Report a problem or side effect.
The SSAs support the role of the TGA as part of the Australian Government’s Department of Health in the regulation of therapeutic goods and the monitoring and enforcement of standards. It supports the action it has taken against Medtronic and looks forward to the resolution of that matter. We are extraordinarily disappointed that, yet again, a large multi-national corporation with more than sufficient resources to do the right thing has once again appeared to have cut corners to suit its bottom line.