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Weitz & Luxenberg Informs the Public of Potentially Defective Advanced Bionics Cochlear Implants


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The U.S. Food and Drug Administration (FDA) is seeking a $2.2 million penalty against Advanced Bionics, the California manufacturer of cochlear implants.

Certain of the company's HiRes90K cochlear implants, according to the FDA website, may "pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss."

According to the FDA's revised April 8, 2008 FDA News Release, "the complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products."

The FDA's revised News Release also states that the "alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the cochlear implant by testing lots under actual or simulated use when the unapproved vendor's component was used...[and] that Advanced Bionics shipped cochlear implants in violation of the law between January 2005 and July 2006. Two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor."

If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant, and have suffered physical or emotional injuries due to a malfunctioning implant, please complete the form below. A representative from our firm contact you as soon as possible.

For more information:

View the Amended FDA Complaint and the FDA's updated News Release.

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Please complete the following questionnaire:

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Date Device Was Implanted:
Has your implant or related components failed to work properly?
Please Describe Any Problems or Injuries Caused by the Device:
Has your defective implant device been removed and if so when?
How did you find Weitz & Luxenberg? (Internet search, friend who found our website and became a client, referral)
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see also:

Research Center Some Advanced Bionics Cochlear Implant Carry Risks--Get Lawsuit Info
Harmed by Advanced Bionics cochlear implants? FREE lawsuit evaluation

Our Press Release Some Advanced Bionics Cochlear Implants a Health Risk--Lawsuit Info
Lawsuit info: Some recipients of Cochlear Implants may risk failure.

Whistleblower Whistleblowers: Report Illegal Activity at Your Job - Lawyer review
Concerned about recrimination if you are a whistleblower? Lawyer info

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