The Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia (Federal Court) against Medtronic Australasia Pty Ltd for the alleged unlawful supply of the Infuse Bone Graft Kit (Kit).
The Kit contained a medicine, and other components, used to stimulate bone growth in patients.
The TGA had previously approved a medical device consisting of a metallic spinal infusion cage (LT Cage) for use in combination with the Kit. The medical device was intended for use in spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4 to S1. However, the TGA had never approved the Kit for use without the LT Cage. The medical device consisting of the LT Cage and Kit has been cancelled from the Australian Register of Therapeutic goods.
The TGA's investigations indicate that Medtronic supplied the Kit, without the LT Cage, to a large number of hospitals. Specifically, TGA alleges in the proceedings there were 16,290 unlawful supplies of the Kit between 1 September 2015 and 31 January 2020.
The Kit was used in a range of surgeries outside of the intended purpose for which the medical device (i.e., the Kit and LT Cage) was approved by the TGA. Evidence provided to the TGA indicates the Kit was used in procedures on the clavicle, hand, scapula, knee, leg, foot, jaw and used in procedures on children (who were not yet skeletally mature).
The Kit, or the medicine and other therapeutic goods within it, had not been assessed for efficacy or safety nor approved by the TGA for use in these circumstances.
