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Your pulse on medical device recalls, warnings and lawsuits

CONSUMER ALERT

Attune Knee Replacement System

Recall Information
Recalled in June 2015 for early failure and destabilization of the knee.
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News & Alerts on the Medical Device Industry

ATTUNE® Knee Replacement System
In June of 2015 the FDA recalled the ATTUNE® Knee Replacement System which is made and marketed by DePuy Synthes, a medical device division of Johnson & Johnson. In its warning letter to DuPuy, the FDA stated that parts of the knee replacement system were changed or replaced without FDA approval and that these parts were dangerous and could result in painful, costly and time consuming revision surgery. Worldwide, more than 700,000 total knee replacement surgeries used the Attune device.
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June 3, 2019
$1 Billion Johson & Johnson Pinnacle Hip Implant Settlement

Sales of the Pinnacle Hip Replacement System, manufactured by DePuy, a medical device divison of Johnson & Johnson, were halted in 2013 but that was too late for many recipients who needed revision surgery. Larger settement amounts will be awarded to those with more serious injuries and illnesses caused by this metal-on-metal hip implant. These include hip pain, hip replacement failure, infection, tissue necrosis and metallosis.

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May 28, 2019
Textured Breast Implant Ban Arrives in North America

After Canada's health agency suspended Allergan's licenses for their Biocell textured breast implants, the company stated it will voluntarily recall and cease selling them in Canada. Allergan also removed these implants in Europe after France ordered a recall.Textured breast implants have been linked to breast-implant associated anaplastic large cell lyphoma (BIA-ALCL), a rare form of cancer. As of now, the U.S. FDA has not banned textured breast implants.

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May 28, 2019
Ethicon Files Change of Venue Motion

Ethicon, a subsidiary of Johnson & Johnson, is the primary defendant in almost 90 pelvic mesh personal injury cases filed in Pennsylvania. They filed a motion to move the trials outside of the Philadelphia area or to have a pre-trial cooling off period. Attorneys for Ethicon contend that the amount of pelic mesh media coverage will unfairly influence the jury in this mass tort matter.

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May 24, 2019
Medical Device Guardians Act to Empower Doctors

The Medical Device Guardians Act, H.R. 2915 will amend the Federal Food, Drug and Cosmetic Act to classify physicians as covered medical device users. This bill states that doctors are in the best position to identify and report defective devices. This bill will also provide some civil lawsuit protection to doctors who filed FDA reports.

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OUR MISSION

Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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