Via a press release dated November 23, 2010, Sonova AG, the parent company of Advanced Bionics issued a voluntary, worldwide recall of all Advanced Bionics HiRes90k cochlear implant devises. According to that press release, there have been two reported instances where a HiRes90k cochclear implant malfunctioned and explantation was required, requiring unnecessary surgery for the cochlear implant recipient. In the reported cases, the malfunction caused the patient to experience “severe pain, overly loud sounds and/or chocking sensations, at 8-10 days after initial activation of their device.”
This is not the first time that Advanced Bionics has recalled its HiRes90k cochlear implant devices. In September, 2004, the all of these devices were recalled when users started to experience device failure caused by high moisture in the devices. In Marcy, 2006, Advanced Bionics again issued a recall of their HiRes90k devices that contained a vendor B / AstroSeal feedthrough. The feedthrough component is critical to the HiRes90k devise and this malfunction caused led to a suit by the FDA against Bionics in 2007 for selling adulterated medical devices which contained AstroSeal feedthroughs around the world. That lawsuit resulted in a settlement where Advanced Bionics paid a $1.1 million fine to the FDA; former CEO Jeff Greiner also personally paid the FDA $75,000.
Attorneys at Childers, Schlueter & Smith, LLC are currently representing clients around the globe who are recipients of failed Advanced Bionics cochlear implants. Given the most recent recall of the HiRes90k, our firm is offering free case evaluations and consultations related to the failure of devices included in this most recent recall. If you or a loved one experienced such a failure 8-10 days after activation of an Advanced Bionics HiRes90k cochlear implant device, we encourage you to get in touch with us immediately, and we will fly to meet with you and discuss your rights and options. We also continue to offer free case evaluations for other failed Advanced Bionics cochlear implants that are not included in the November 23 recall.
To obtain a copy of the press release announcing the recall, and to get more information about your options, please contact attorney M. Brandon Smith at 1-800-641-0098 or via email at firstname.lastname@example.org. Do not let Advanced Bionics pressure you into thinking you should not contact an attorney for legal advice. With three recalls of this medical device in a 6 year period, you or your loved one have the right to choose whether to seek legal counsel to protect your rights and to seek justice on your behalf.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.