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DePuy Email Discussed ASR Hip Implant Failures Year Before Recall | cialis online

DePuy Email Discussed ASR Hip Implant Failures Year Before Recall

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In the midst of an ongoing, global debacle concerning DePuy’s metal-on-metal ASR hip implant devices, The New York Times reports that DePuy Orthopaedics executives discussed the ASR failure one year before the recall was issued.

It seems that a vice president at DePuy, a unit of Johnson & Johnson, wrote in a company email that the FDA refused to approve the articular surface replacement (ASR) device and that a review of DePuy studies revealed that the device failed early in what was described as “significant” numbers, which meant that patients would have to undergo revision surgery, said The Times. The email was dated August 21, 2009.

As The Times pointed out, the email paints a very different picture from statements Johnson & Johnson has made about the hip device in recent years. As a matter-of-fact, Johnson & Johnson argued that the device was safe and its studies rebutted surgeon and global regulators’ claims that the ASR device was defective, said The Times. While the FDA refused to approve the ASR hip implant device discussed in the 2009 email, it was sold overseas and another version, which was implanted in about 30,000 U.S. patients, was recalled.

The emai was written by Pamela Plouhar, a vice president at DePuy, in the days after the agency confidentially told DePuy that it was rejecting one version of the device for sale in the U.S. Plouhar wrote to three other key executives at DePuy, including then-president, David Floyd, to explain the agency’s reasons for rejecting the device, said The Times.

Plouhar wrote that the rejected ASR did not meet FDA standards and that at significant issue was the deices premature failure rates seen in clinical trials, said The Times. Plouhar also indicated that it could take years to conduct new studies of the device, saying, “The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk,” according to The Times. There had been “a significant number of revisions in the ASR group” when compared with “very few in the control group,” Plouhar added.

Andrew Ekdahl, DePuy’s current president, said in a recent statement written in response to a prior Times article, that the suggestion that the agency concluded there were safety issues with the ASR were “simply untrue,” wrote The Times. DePuy does not appear to have broken any laws in not releasing information on the agency ruling and the nonapprovable letter—the FDA does not typically release these letters as they tend to contain confidential business information—but, DePuy’s decision to remain silent might affect how it is perceived when defending itself in the 5,000 lawsuits pending against it, noted The Times.

Meanwhile, Plouhar’s email said DePuy is looking at available data to address some of the agency’s issues and expressed concern regarding “the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority with additional downside risk. Any need to enroll new ASR cases will significantly delay the PMA submission and approval by years,” The Times reported. “We will provide you with a more detailed evaluation in the coming weeks, but we did want you to be aware of the significant risk associated with the FDA approval of this product. This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates,” she concluded.

The ASR Hip Resurfacing System and the ASR Acetabular Hip Implant were globally recalled in August 2010 following release of data from the National Joint Registry of England and Wales in which it revealed that 1 out of every 8 patients (12%-13%) who had received the devices needed revision surgery within five years of the original implant. At the time of the recall, DePuy sold more than 93,000 units of the hip replacement devices. Last year, a British study revealed failure rates of up to 50% at six years for patients who were implanted with the DePuy ASR hip implant in a total hip replacement procedure.

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