The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved.
The European Medicines Agency (EMA) launched a review of InductOs—the device is sold in the U.S. as InFuse—after Dutch and Spanish authorities inspected a site that makes an absorbable collagen sponge that is part of the device, Reuters reports.
The EMA said the manufacturer had not taken adequate measures to prevent particle contamination of the sponges. Medtronic says the EMA withdrew the Good Manufacturing Practices certificate, which is mandatory for product licenses in Europe, from a plant operated by a third-party manufacturer. Medtronic, which has its headquarters in Ireland, is working with the manufacturer to address the EMA’s concerns. The company expects the plant to be “up and running soon,” according to Reuters.
In a statement emailed to Reuters, Medtronic says the manufacturing issue presents no risk to patients. “Existing supplies of InductOs in the market are safe for use,” according to Medtronic.
InductOs is implanted to promote new bone growth in patients with spinal disc problems and leg fractures. The European Commission granted approval to the device in September 2002 for use in the treatment of acute tibia fractures in adults. Approval for spinal disc problems came in April 2005.
The InductOs kit contains the active ingredient dibotermin alfa (a recombinant human bone morphogenetic protein), a solvent, and an absorbable collagen sponge (ACS). The EMA has classified the ACS as an excipient of InductOs, making it subject to inspection under EU good manufacturing practice (GMP) guidelines, according to RAPS (Regulatory Affairs Professionals Society).
The sponge in the InductOs is manufactured by Integra LifeSciences at a plant in the U.S. A January 2014 inspection of the Integra’s plant uncovered “a number of major deficiencies.” Integra was given a corrective action plan and was restricted from importing the ACS to the EU until inspectors could return to “assess the progress in eliminating the major deficiencies.” In the follow-up inspection in April 2015, inspectors found Integra had not taken adequate steps to eliminate “contamination of ACS with particulate matter,” according to RAPS.
Though the EMA said there was no indication of risk to patients linked to the inspection’s findings, the agency said its Committee for Medicinal Products for Human Use considered that the quality of InductOs could not be assured under the current manufacturing process.
In the U.S., Medtronic has long faced problems with the InFuse device, including complaints that it marketed the device for uses not approved by the Food and Drug Administration and charges that it improperly influenced research. Studies that Medtronic claimed were “outside objective reports” were in fact written or rewritten by Medtronic. Court documents in a lawsuit filed earlier this year allege Medtronic was actively involved in the writing and editing of articles and in decisions about the inclusion or exclusion of health and safety information. The lawsuit alleges that Medtronic omitted and concealed information about serious adverse events revealed in the research. Independent experts reviewing the original InFuse studies confirmed that InFuse did not provide benefits over traditional bone grafts and, further, the device exposed patients to serious and undisclosed increased risks and complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain.