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Advanced Bionics Cochlear Implant Lawyers

The national product liability lawyers at SHOOP | A PROFESSIONAL LAW CORPORATION continue to investigate and take on claims involving the Advanced Bionics Hi Res 90k Cochlear Implant. 

A warning letter from the U.S Food and Drug Administration ("FDA") - detailing the issues related to the Hi Res 90k - summarized a lengthy inspection into the company's manufacturing processes related to their cochlear devices and revealed that Advanced Bionic's (AB) devices were misbranded under section 502(t)(2) of the Federal Food, Drug and Cosmetic Act ("Act"). FDA concluded that the Hi Res 90k implants were misbranded due to AB's failure or refusal to furnish any material or information as required by or pursuant to section 519 of the Act with regard to the device. Specifically, FDA found that the Advanced Bionics device had experienced numerous failures - one of the principle "root causes" for failures was the exposure of the diodes powering the cochlear device to experience moisture in the housing of the device.

When FDA reviewed failure modality data for approximately thirty (30) explanted Hi Res 90K devices identified moisture in nearly two of every three cochlear implants tested for residual moisture. FDA additionally found that AB had knowledge of and otherwise identified moisture in 6 of 11 explanted devices that were laboratory tested and found to be hermetically sealed and still working. Advanced Bionics, however, failed to report this information in its MDRs.

Advanced Bionics replied to FDA and advised them (as contained in the FDA Warning Letter) that the company had "planned to conduct an investigation for the device failures" due to hermetic issues and also advised that they would make changes in the manufacturing process and provide FDA with quarterly reliability reports. A meeting was eventually held between FDA and Advanced Bionics to discuss the findings from the FDA inspection, and FDA made clear in its warning letter to Advanced Bionics that the company agreed to validate its manufacturing process (the vacuum bake process), implement quality review inspections of the vent hole of the implant, otherwise conduct destructive testing, and then correct all observations listed by FDA and to cease shipment of the Hi Res 90k until the outstanding compliance issues had been resolved. AB, however, continued to ship the device and more implant recipients required risky revision procedures.

Aside from representing clients nationally who have suffered injuries as a result of the Advanced Bionics recall, the lawyers at SHOOP | A PROFESSIONAL LAW CORPORATION continue to represent recipients of failed Cochlear Nucleus CI512 implants. No other law firm in the country handles more claims involving these cochlear devices. Remember - if you or your child has suffered a confirmed failure of a cochlear implant, it is important that you do not attempt to negotiate a settlement on your own with either Cochlear Ltd., or Advanced Bionics and NEVER enter into any written settlement agreement with either company for remuneration or product services.

If you suffer a failure of your cochlear implant, you should immediately contact the national product lawyers at SHOOP | A PROFESSIONAL LAW CORPORATION for a free consultation to discuss your legal rights - AND for a free medical record review to determine if you have a claim. You will not find a more balanced team of experienced attorneys who genuinely care about their clients and deliver proven results.

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Shoop | A professional Law Corporation

Shoop A Professional Law Corporation
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Phone: 323-677-1836
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