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New Zealand to Overhaul Medical Device Regulatory System

Aug 25, 2015

About half of the metal-on-metal (MoM) hip implants received by thousands of New Zealanders about a decade ago had significant defects, according to the New Zealand Herald.

The Herald says there is no official record of the injuries suffered by people who received the faulty hips because the recall and monitoring of the devices was handled by manufacturers and surgeons, not by the government health agency.

The Weekend Herald investigation found that about 2,500 of 5,000 metal hip devices implanted in New Zealanders were subject to health and safety warnings and recalls, with the latest safety warning coming in February 2015 for a hip device manufactured by Smith & Nephew. Warnings have also been issued for Zimmer and Stryker hip. Of the devices in question, about 200 caused medical problems serious enough that the hips needed to be removed and replaced, which is known as revision.

Metal-on-metal hips have been a problem worldwide and have been subject to warnings and recalls by a number of regulatory agencies. Recipients of the hips have reported injuries and side effects including pain, loosening of the joint, hip dislocation, difficulty walking, cysts around the joint, and metal poisoning. Thousands of hip recipients in the U.S. have filed lawsuits against the manufacturers. In 2014, Stryker announced a settlement program for patients who suffered injuries from its MoM hips.

In 2012, the British Medical Journal questioned device regulatory systems and the high chromium and cobalt readings in the blood of patients who had metal-on-metal hips. A 2012 article in The Lancet indicated a higher than normal revision rate for MoM hips. Dr. Peter Devan, a hip-replacement surgeon who advised Australia’s regulatory body, said the risk rating for MoM devices was upgraded after the devices became popular. Peak use of MoM hips came in 2007, at about the same time the risk was upgraded, according to the Herald.

Documents the Herald obtained from Medsafe, the government’s medical device regulator, for medical devices, show that 2,551 hips – slightly more than half of those implanted – were subject to safety or hazard notices. The agency had no role in approving the devices but looked to overseas regulators for guidance, a Medsafe spokesman said. While New Zealand’s health minister, Jonathan Coleman, stood by the regulatory system’s handling of the hip issue, he said the system needed overhaul. Officials are developing a comprehensive new regulatory scheme to cover medical devices, medicines, and cell and tissue therapies; the bill will reach Parliament next year. The proposed new law would regulate the quality, safety, and effectiveness of all therapeutic products. Professor Tom Faunce of the Australian National University’s College of Law and College of Medicine said every country needs its own proactive medical device regulator when dealing with large, multinational corporations. New Zealand should not outsource device regulation to other countries, he said.

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