|Stryker's Triathlon knee replacement is among many orthopedic implants sold without a warranty.--Courtesy of Stryker|
Stryker, Johnson & Johnson, Wright Medical, Smith & Nephew, Zimmer: Each makes heavily scrutinized hip and knee implants, but none offers a warranty to protect patients if something goes awry. Now, a consumer group is demanding change, urging the world's largest makers of orthopedic implants to guarantee their products for 20 years.
Consumers Union, the policy arm of Consumer Reports, wants the industry to commit to covering the full cost of revision surgery if implants fail while under warranty. Currently, repeat procedures to fix faulty devices are largely paid for by patients and Medicare, saddling the healthcare system with hundreds of millions of dollars in costs, the group said.
And, with the demand for hip and knee replacement surgeries expected to reach 4 million a year by 2030, the problem will only worsen if the industry doesn't change its practices, Consumers Union Safe Patient Project Director Lisa McGiffert said.
"Patients have a right to know how long medical device manufacturers are willing to stand by their products," McGiffert said in a statement. "While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty."
In June, the group sent letters to Biomet, Stryker ($SYK), Johnson & Johnson ($JNJ), Wright Medical ($WMGI), Smith & Nephew ($SNN) and Zimmer ($ZMH), asking them to provide 20-year warranties that cover the full cost of revision surgery, maintain a patient's right to sue, provide clear explanations of denied claims and don't disqualify patients with illnesses unrelated to device failure.
On Tuesday, none of the companies responded to email questions from FierceMedicalDevices on whether they plan to change their warranty practices. Only Biomet offers a warranty in the U.S., covering its Oxford Partial Knee implant.
Over the past two years, lawsuits tied to now-recalled orthopedic implants have cost the world's largest manufacturers hundreds of millions of dollars. In each case, companies like Stryker and J&J have averred that because their products went through the FDA's less-strenuous 510(k) clearance path, they are safe and dependable under the terms of the law.
"If that's the case, they should have no objection to offering warranties to back up those claims," McGiffert said.
- read Consumers Union's statement
- check out its letter to manufacturers