Tag Archives: womens health

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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FDA to Announce Essure Review Decision in February

FDA-Essure-Decision

The U.S. Food and Drug Administration (FDA) has said it will announce its decision about what action it will take on Bayer’s permanent birth control device Essure in February 2016. The FDA decision will be based on information gathered by the … Continue reading

Posted in Defective Medical Devices, Essure, Health Concerns | Tagged , , , , |

Update on FDA Evaluation of the Safety of Essure Birth Control System

FDA Evaluation of the Safety of Essure Birth Control System

The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system. Essure—a form of permanent birth control (female sterilization)—is under FDA review in response … Continue reading

Posted in Defective Medical Devices, Essure | Tagged , , , , |

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