Have You or a Loved One Been Injured by an Infuse Bone Graft?
When patients undergo surgery for a serious problem they shouldn’t wind up with a worse problem from the surgery. Call Isaacs & Isaacs now if you need to know if you have grounds for a Medtronic lawsuit. We’ve recovered over $1 billion for clients in Kentucky,Ohio and Indiana. Call 800-800-8888 for a no-charge case evaluation. We’re here for you 24/7
What are the uses for Infuse Artificial Bone Graft?
In 2002 the FDA approved the Medtronic Infuse bone graft for use in an intra-surgical procedure designed to prompt bone growth in the lower (lumbar spine). Later that year the FDA approved it’s use for fractures of the tibia and sinus and alveolar ridge augmentation procedures.
Medtronic made the Infuse bone graft from a synthetic protein called recombinant human bone morphogenetic proteins (rhBMP-2). Medtronic created it to allow doctors to perform spinal surgery without using bone from another part of the body or donors. The device consists of a pair of LT-CAGES (small metallic devices which resemble thimbles) that contain sponges which hold the protein mixture. A specific surgical technique for inserting the device in between vertebrae in the lower spine is the one the FDA approved.
Infuse Bone Graft Complications
The FDA approved the Medtronic Infuse for particular use in lower spine surgery. It is supposed to stimulate new bone growth in the lower spine. However it has been shown to cause serious complications, including:
- Inflammatory reactions
- Back and leg pain
- Spinal nerve pain
- Retrograde ejaculation
- Male sterility
- Bone tissue degeneration
- Unwanted bone formation
Off-Label Use of a Medtronic Bone Graft
Medtronic stands accused of promoting off-label use (mislabeling), a federal crime. The Senate Finance Committee and the FDA investigated Medtronic, and numerous lawsuits have been filed alleging that Medtronic not only concealed negative side effects but paid researchers conducting trials of the device millions to write misleading reports. Others accused Medtronic of encouraging doctors in off-label use, so off-label use became the primary use of the Medtronic Infuse bone graft, with a corresponding boost in sales.
An article published in Surgical Neurology International in 2011 reveals that the majority of surgeries performed with the Medtronic Infuse device at one “institution” were off label (170 of 177 procedures).
Patients all over the US who received the device in a way that was not approved by the FDA have filed lawsuits for the following side effects/complications:
- Trouble swallowing
- Trouble breathing
- Trouble speaking
- Chronic pain due to nerve injuries
- Chronic leg/arm pain
- Retrograde ejaculation
- Male sterility
- Uncontrolled bone growth
Cauda Equina Syndrome (lower back pain; numbness; incontinence; sexual dysfunction)
In July of 2008, the FDA issued a warning concerning Medtronic Infuse Bone Graft use that did not fall within the initial 2002 clearances, stating that risks were associated with the use of the bone graft on the cervical spine. The warning said specifically, “that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and these products are not approved by the FDA at this time.”
Senate Investigation: Downplaying Side Effects Seen in Trials
In June 2011 Senators Charles Grassley and Max Baucus of the Senate Finance Committee sent a letter to Medtronic. The letter demanded production of all documents and communications about adverse side effects/complications from use of Medtronic Infuse Bone Graft, both within the company and to various others, including clinical researchers , medical journals/representatives, the FDA, and physician consultants.
The letter also demanded production of payment records to Infuse clinical investigators and “corporate entities of which Medtronic-sponsored Infuse clinical investigators are principals.” The letter also warned against destroying or modifying any information related to the investigation.
After a 16 month investigation, the SFC concluded that Medtronic manipulated studies and bribed researchers and physicians who authored articles about Infuse for medical journals, even going so far as to edit articles about side effects from the device. The investigation revealed that Medtronic paid over $210 million dollars to researchers, writers and others, allegedly to mislead people about the safety of Medtronic Infuse devices. Senator Baucus issued a sharp rebuke to Medtronic for violating patients’ trust. Since this investigation, Medtronic has continued to be in trouble with the federal government.
Medtronic Infuse Settlement
Victims/survivors of the Medtronic Infuse Artificial Bone Graft device have filed numerous lawsuits in State and Federal Courts across the country. So far Medtronic has agreed to settle 950 claims for $22 million. The company also settled with the federal government in three separate actions for a total of $18.5 million. Despite allegations and settlements Medtronic has not admitted to any wrongdoing.
A Infuse Bone Graft Law Firm Can Help With A Medtronic Lawsuit
If you are experiencing any of the above symptoms after receiving a Medtronic Infuse device during surgery you need to get in touch with an experienced Medtronic lawsuit attorney right away. If you are not sure whether the surgeon used a Medtronic Infuse device in your surgery it is especially important to talk to a lawyer.
At Isaacs & Isaacs our skilled personal injury attorneys have decades of experience fighting for victims of toxic pharmaceuticals. We will review your medical records, interview witnesses, and determine exactly what information we need to look for. The more evidence we gather, the stronger your claim will be.
We want to see high ethical standards and transparency from pharmaceutical companies. We believe that people who have been harmed from another’s negligence deserve just compensation for their injuries. We will work hard to ensure the best outcome for your case.
You shouldn’t have to pay money to receive justice. The company that hurt you should pay. We will use our skill and resources to win your case, and we won’t get paid until you do.
Call us now at 800-800-8888 for a no charge case evaluation.