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Medtronic INFUSE

We Are No Longer Accepting Medtronic INFUSE Cases. This information is provided for reference purposes only.

Medtronic INFUSE

The experienced nationwide network of Infuse Attorneys at the law offices of Jones Brown is ready to assist in your legal claim for injuries suffered as a result of the implantation and use of a Medtronic INFUSE device.

The Medtronic INFUSE device is also as a bone morphogenetic protein-2 and was used in spinal surgery to grow bone and help fuse vertebrae. The FDA approved this device for use in a type of spine surgery called anterior approach lumbar fusion. This is the ONLY type of spine surgery for which Infuse is approved, though the FDA did later grant clearance for its use in two types of dental surgeries.

Medical reports show that in 2011, more than 85 percent of INFUSE operations were for off-label uses and unapproved procedures. Evidence of Medtronic’s false advertising of their product was uncovered in an investigation conducted by the United States Senate Finance Committee, who found that the medical company paid more than two million dollars in “consulting fees” to the authors of the misleading studies.   In 2011, the Senate Finance Committee published a letter written to the leading doctors at Medtronic highlighting the company’s questionable financial ties and faulty studies, writing,

Despite this limited approval, Medtronic INFUSE is alleged to have frequently been used off-label in other spine procedures, such as cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures. These off-label uses put patients at risk for serious, and even life-threatening, injuries and adverse events.

These Adverse events include but are not limited to:

  • Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury.
  • Difficulty swallowing
  • Difficulty breathing
  • Difficulty speaking
  • Ectopic or uncontrolled bone growth at or near the site of the surgery
  • Nerve injuries causing severe and chronic pain
  • Ongoing or chronic radiating pain in the legs or arms -(i.e., neuritis, radiculopathy or radiculitis)
  • Retrograde ejaculation, or other urn-genital injuries in male patients
  • Cauda Equina Syndrome
  • Back and leg pain,
  • Cyst formation
  • Disc space collapse
  • Infection
  • Implant displacement
  • Malignancy

Medtronic has reported that INFUSE has been implanted in more than 500,000 patients by more than 2,300 surgeons in the United States.

Our nationwide network experienced attorneys and medical staff here at Jones Brown Law are ready to help those who have been implanted with an Infuse device and experienced complications.

Our legal action is against the manufacturer for allowing their product to be used for these off-label, non-FDA Approved purposes.  Our legal action is NOT against the surgeon or medical staff involved in your diagnosis, surgery or treatment.

We strive to make working with us as simple, easy and uncomplicated as possible.

To allow us to get started reviewing and working your claim CLICK HERE and fill out a short and  PRIVATE information form pertaining to your condition and symptoms.

After Receiving Your Information We Will:

  • Direct you on where and how to get the medical and surgical records we need to review including the Operative Report that identifies the use of the Infuse device.
  • Explain how to get your records to us for medical and legal review. We offer many electronic and traditional options.
  • Advise you after our review if we will pursue your claim. If we accept your client we will provide you with the necessary documents to hire us as your attorneys for you to review, sign and return.
  • Be in touch with you to begin this process and walk you all the way through it.
  • Be in touch with you to begin this process and walk with you all the way through it.

Sources:

http://www.medtronic.com/us-en/patients/treatments-therapies/bone-graft-lumbar-degenerative-disc-disease/infuse.html

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&sortcolumn=do_desc&PAGENUM=500&pmanumber=P000058

Do You Have Questions? We Have Answers. Talk to a Jones Brown Attorney Now.

At Jones Brown, we’ve made it our mission to provide legal representation of the highest caliber at a rate that is affordable to everyone. Our goal is to make legal representation and services attainable for all those who seek it, without the need to compromise ethics, experience, or quality of service. All of our attorneys adhere to a strict code of professional ethics, upholding our Client Bill of Rights, to ensure that our clients are treated with the respect and attention they deserve.

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