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FDA’s Role in Approving DePuy ASR Hip Implant Examined

FDA’s Role in Approving DePuy ASR Hip Implant Examined

May 2, 2012 – 3:53 pm | Comments Off | 188 views

ProPublica reports on Food and Drug Administration (FDA) involvement in approving DePuy’s metal-on-metal ASR hip implant for market.

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FDA’s Role in Approving DePuy ASR Hip Implant Examined

May 2, 2012 – 3:53 pm | Comments Off | 188 views

FDA’s Role in Approving DePuy ASR Hip Implant Examined

ProPublica reports on Food and Drug Administration (FDA) involvement in approving DePuy’s metal-on-metal ASR hip implant for market.

Read the full story »

Orthopedic Surgeon Speaks About His Experience as a DePuy Hip Implant Patient

April 6, 2012 – 10:03 am | Comments Off | 613 views
Orthopedic Surgeon Speaks About His Experience as a DePuy Hip Implant Patient

Consumer Reports profiles Dr. Stephen Tower, a 55-year-old orthopedic surgeon from Anchorage, Alaska, and an athlete who eagerly received his DePuy metal-on-metal hip in 2006. Dr. Tower tells Consumer Reports that he chose his DePuy …

Hip Recall News: FDA To Review Safety of Metal-on-Metal Hip Implants

March 30, 2012 – 12:52 pm | Comments Off | 450 views
Hip Recall News:  FDA To Review Safety of Metal-on-Metal Hip Implants

In the latest news on hip implant recalls, the FDA announced today that it will hold a meeting in June 2012 to review mounting safety concerns about the failure rates of metal-on-metal hip replacements. Metal …

DePuy Metal-on-metal Revision Surgery: NPR Profiles Joint Replacement Patient

March 20, 2012 – 1:12 pm | Comments Off | 599 views
DePuy Metal-on-metal Revision Surgery: NPR Profiles Joint Replacement Patient

National Public Radio (NPR) follows Susy Mansfield, a DePuy metal-on-metal hip patient with a failed implant, on her journey to recovery through revision surgery. It is estimated that over half a million American patients have …

Hip Replacement Recall Update – British Medical Journal Calls For End To Use Of Certain All-Metal Hip Joints

March 19, 2012 – 4:40 pm | Comments Off | 541 views
Hip Replacement Recall Update – British Medical Journal Calls For End To Use Of Certain All-Metal Hip Joints

The Lancet, a leading British medical journal, published on March 13, 2012, a study of metal-on-metal hip implants which examines hip implant data from the National Joint Registry of England and Wales. The study concludes …

British Regulators Advise Lifetime Monitoring for Metal-on-Metal Hip Implant Patients

March 13, 2012 – 10:31 am | Comments Off | 394 views
British Regulators Advise Lifetime Monitoring for Metal-on-Metal Hip Implant Patients

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release on February 28, 2012, updating their advice on patient monitoring for metal-on-metal hip implants such as DePuy’s metal-on-metal ASR and Pinnacle hip implants. …

Risks of Metal Hips Known But Patients Kept in Dark, British Medical Editor Charges

February 29, 2012 – 12:48 pm | Comments Off | 491 views
Risks of Metal Hips Known But Patients Kept in Dark, British Medical Editor Charges

“Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices,” writes Deborah Cohen, an editor with the British Medical …

Year Before U.S. Recall, J&J Executive Spoke of High Failure Rates in ASR Hip Implant, New York Times Reports

February 22, 2012 – 4:58 pm | Comments Off | 484 views
Year Before U.S. Recall, J&J Executive Spoke of High Failure Rates in ASR Hip Implant, New York Times Reports

The New York Times reports that in August 2009, days after Johnson & Johnson received a letter from the FDA rejecting their metal-on-metal ASR Hip Resurfacing System for U.S. sales, company executive Pamela Plouhar emailed three other top executives to explain the FDA’s decision with statements that “contrast those made by the company in recent years about the all-metal hip.”

DePuy Sold ASR Hip Implant Overseas After FDA Rejected Device Over Safety Concerns

February 22, 2012 – 12:08 pm | Comments Off | 359 views
DePuy Sold ASR Hip Implant Overseas After FDA Rejected Device Over Safety Concerns

The New York Times reports, medical device manufacturer Johnson & Johnson continued to sell its ASR metal-on-metal hip implant devices abroad even after receivng a letter from the United States Food and Drug Administration (FDA) rejecting the hip implant’s sale in the U.S. The FDA rejected the hip implant device after reviewing Johnson & Johnson safety studies, and sent a nonapproval letter to the company in August 2009.

DePuy Hip Recall Lawsuits Cause Johnson & Johnson To Take $3 Billion Charge

January 25, 2012 – 4:25 pm | Comments Off | 988 views
DePuy Hip Recall Lawsuits Cause Johnson & Johnson To Take $3 Billion Charge

Johnson & Johnson has set aside $3 billion in special charges on its quarterly earnings statement to account for the costs of product liability litigation, Reuters reports. Johnson & Johnson’s subsidiary DePuy Orthopaedics recalled its …

FDA Calls for DePuy to Submit Devices for Approval Process

January 23, 2012 – 5:33 pm | Comments Off | 524 views
FDA Calls for DePuy to Submit Devices for Approval Process

Mass Device reports that the U.S. Food and Drug Administration (FDA) warned Johnson & Johnson’s subsidiary company DePuy Orthopaedics that several of its hip and knee implants were improperly marketed.