In 2002 the U.S. Food and Drug Administration (FDA) approved the Medtronic Infuse Bone Graft for use in fusing bones or vertebrae in the lower back for people with spinal fusion surgeries. It was successful for many years until the manufacturers became greedy and allegedly paid surgeons to promote and to use this bone graft “off-label.” Life-threatening complications were directly linked to the off-label use of this product.
The Medtronic Infuse Bone Graft is used during surgery to stimulate bone growth and replace the damaged spinal disks. Medtronic Infuse was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic Infuse Bone Graft is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures.
In 2002, when the FDA granted Medtronic approval for the Infuse Bone Graft, it was meant for use limited to the lumbar spine (lower back) and for some dental procedures. The FDA approved the Infuse Bone Graft for the treatment of degenerative disc disease and open fractures of the tibia (lower leg). The FDA also approved Medtronic Infuse Bone Graft for use in sinus augmentation and localized alveolar ridge augmentation (dental procedure).
Patients who received the Medtronic Infuse bone growth stimulator in the cervical spine have reported complications including difficulty swallowing or speaking, compression of the airway, nerve damage with pain radiating down the arms and/or legs, uncontrollable bone growth at or near the surgical site, as reported in 75 percent of patients post operatively, swelling of the neck or throat, cancer of the throat, thyroid, breast, prostate and other areas. Medtronic Infuse has also been linked to retrograde ejaculation, which can lead to male sterility.
In July 2008, after the FDA received at least 38 reports of complications, they issued a warning concerning off-label Medtronic Infuse Bone Graft use, stating that the risks were associated with the use of the bone graft on the cervical spine. The FDA stated, “that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.” rhBMP-2 (recombinant human bone morphogenetic protein-2) is a genetically engineered version of a protein everyone’s body produces naturally in small amounts to regulate bone growth and healing.
According to a study, as many as two out of three surgeries of Medtronic Infuse Bone Graft were used off-label.
The reports included patients who experienced difficulty swallowing, breathing and speaking, caused by a “compression of the airway and/or neurological structures in the neck.” Many of the patients required emergency treatment, including tracheotomies, anti-inflammatory medications, feeding tubes and additional surgeries.
A separate study published in the The Spine Journal suggests that rhBMP-2 usage could cause a higher incidence of male sterility than previously described by industry-sponsored researchers.
The Wall Street Journal reported in September 2008 that FDA records revealed approximately 280 adverse events of patients who experienced serious complications after the bone graft was used off-label.
The Wall Street Journal reported that Medtronic was allegedly paying some doctors who used the bone graft system or who wrote favorable reviews about the product. Medtronic paid a surgeon, Dr. Timothy R. Kuklo, approximately $800,000 over three years, who was accused of fabricating a study that reported positive results for the Infuse Bone Graft. Kuklo allegedly based the study on “falsified information” and forged the signatures of supposed co-authors. Medtronic said that the payments were related to the doctor’s work developing products and speaking at company functions.
Dr. Scott Boden discussed the use of the product off-label with an FDA advisory committee, explaining that the discussion of off-label use should not be the focus of the meeting. Dr. Boden was allegedly paid more than $100,000 a year from Medtronic.
There were at least three lawsuits filed against Medtronic by former employees, who alleged the company gave doctors incentives to use Infuse Bone Graft and other Medtronic spine products, which helped generate sales of more than $3 billion for the manufacturer. Two of the cases were settled without Medtronic admitting wrongdoing.
In December 2008 a Medtronic Infuse wrongful death lawsuit was filed after a woman went into a coma and died following surgery. The lawsuit claimed that the Medtronic failed to warn about the risks associated with the use of the device in the neck, and that Medtronic actively encouraged off-label use, even though they did not have FDA approval.
Another lawsuit claimed that following Medtronic Infuse Bone Graft during a cervical spine fusion, the patient developed severe swelling in the throat requiring an emergency tracheotomy.
A lawsuit was filed in July 2011 against Medtronic and Stryker Biotech, claiming that the companies fraudulently marketed their products for off-label use without FDA approval, causing serious injuries, requiring additional surgery. The surgery made her condition worse.
In September 2011, a personal injury lawsuit was filed against Medtronic. After being implanted with Medtronic Infuse Bone Graft during a lumbar spine unapproved surgery, she developed uncontrolled bone growth in her spine, compressing on nerves. She has been living with chronic, severe pain since the surgery. Her lawsuit further alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved use.
Many patients claim that the pain is so severe since surgery, that they have been taking the strong narcotic painkiller Oxycontin and Fentanyl patches for more than a year. In some patients, the pain did not start until three months post-operative. One patient who filed a lawsuit said her surgeon said her spine turned into ‘Swiss cheese.’ She developed a severe infection and had two blood transfusions. She states that arthritis has set in and believes it is due to the bone graft.
A half million patients who had Medtronic Infuse Bone Grafting contributed to Medtronic’s sales of $800 million in 2011 alone, according to Medtronic reports. Medtronic may need to use some of that money toward lawsuits.
Medtronic has allegedly paid millions of dollars to physicians to publish fabricated favorable reports on their Infuse Bone Graft while hiding dangerous, life-threatening side effects. They put their greed and profits before the safety and concern of thousands of patients. Feel free to comment on this blog post.
If you or a loved one has suffered injury following placement of Medtronic Infuse Bone Graft, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).