Medtronic has withdrawn its Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion device from the Australian market as of March 23, according to a statement provided to Becker's Spine Review.
The decision came after a February News Corp investigation, which reported that spine surgeons were using the product "off label," according to The Daily Telegraph. A whistleblower revealed that the device was widely being used in unapproved ways without the cage designed to contain it.
Pulled from the Therapeutic Goods Administration — Australia's medical regulator — the product can now only be supplied through a special access program.
Medtronic provided the following statement to Becker's Spine Review:
"Given the evolution of clinical practice for use of Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion device in Australia, Medtronic Australasia voluntarily withdrew its Australian Register of Therapeutic Goods entry as of 23 March, 2020.
The decision to withdraw is not related to product safety — nor is it taken lightly given the potential impact upon patients. The TGA has been consulted regarding the withdrawal and are aware of our intent to seek approval to make Infuse Bone Graft available in future in Australia, taking into account local clinical practice.
Infuse Bone Graft remains an important treatment option in markets around the globe, and we are committed to making this technology available in Australia. We continue to invest in prospective clinical trials globally with the goal of expanding indications for safe and effective use of the product worldwide. In this context, Medtronic is assessing data sources to determine viable paths for expanded indications within Australia and working with the TGA and Department of Health to seek appropriate market access for the benefit of patients."
Since 2008, more than 10,000 people in the U.S. have sued Medtronic alleging that the off-label use of the bone graft was linked to adverse outcomes. The company has reportedly paid out more than $460 million in settlements.