Lawsuits have been filed against the manufacturer of the INFUSE Bone Graft, alleging that the device causes serious side effects. You may be entitled to receive compensation for medical bills, lost income, and pain and suffering, among other losses. We are currently working with some of the more experienced Medtronic INFUSE Bone Graft lawyers around the country and there is no fee unless you obtain a settlement or award. Call us toll-free, or submit a contact form online for a free (no obligation) case evaluation.
Have You Had The Medtronic Infuse Bone Graft
Implanted in Your Neck?
Call the Medtronic Infuse Bone Graft Lawyers of
d’Oliveire & Associates Today!
What Is The Medtronic INFUSE Bone Graft Device?
In July 2002, the FDA approved the Medtronic INFUSE Bone Graft for sale. This medical device was approved to treat Degenerative Disc Disease (DDD), which affects the lumbar region of the spine (lower back). In order to treat DDD, surgeons implant the device using a spinal surgery where the doctor inserts the device from the front of the body.
Why Are There INFUSE Bone Graft Lawsuits?
Lawsuits allege that the FDA has only approved a label using this frontal approach for INFUSE Bone Graft surgeries and that the device was not approved to be used in surgeries where it was implanted from the side or back of the body. They also allege that the device is especially dangerous when using an off label approach to implant it in the neck area.
When the INFUSE Bone Graft was first introduced to the market, it received several positive reviews from medical studies while its competition received negative reviews. It is alleged that adverse side effects were underreported in the first 13 studies of the device in order to increase profits.
Additionally, lawsuits allege that Medtronic may have paid money to doctors to falsify their data, raising the concern that the benefits of the INFUSE Bone Graft may have been inflated while the risks were downplayed. By hiding or downplaying the risks, Medtronic may have caused doctors to unknowingly use dangerous techniques to implant the device.
How Do I Know If I Was Implanted With The INFUSE Bone Graft?
There are two major back surgeries used to treat DDD. The INFUSE Bone Graft is the newer treatment and it was introduced to replace the traditional one. If your procedure required bone to be taken from other parts of your body, or you received bone from another source, then you probably were not implanted with the INFUSE device.
However, if your doctor talked to you about Medtronic, or implantation of a device, then you may have received the INFUSE bone graft. If you are unsure of what surgery you underwent, you should look through your medical records or contact your doctor’s office because they are required by law to give you this information.
What Are Some of the INFUSE Bone Graft Side Effects?
- Failure to fuse
- Migration of the device
- Gastrointestinal problems
- Damage to the spinal cord
In addition to these side effects, FDA adverse event reports and clinical trials have uncovered even more dangers posed by the device. In July 2008, the FDA released a warning about the INFUSE Bone Graft. It based this warning on 38 adverse event reports from patients, who experienced complications after the device was inserted in the cervical/neck region. These reports described how patients had trouble breathing, speaking, and swallowing because the device caused uncontrolled bone growth to obstruct the airways and throat.
Medical trials have also suggested the following side effects may result:
- Nerve damage causing chronic pain
- Cauda equina syndrome (numbness in the lower back and groin region)
- Abnormal or uncontrolled bone growth
- Male sterility, sexual problems, and uro-genital injuries
- Cancer including breast, throat, and thyroid
Are There Medical Studies About The Device?
Early studies of the INFUSE Bone Graft were overwhelmingly positive. However, recent information has revealed that Medtronic allegedly paid millions of dollars to the doctors, who conducted these studies, which may have jeopardized their legitimacy. It has also been alleged that the company encouraged off-label use of the device. A study conducted by the Cleveland Clinic found that by 2007, the INFUSE Bone Graft was used off-label 17% of the time.
In April 2011, The Spine Journal published an article which questioned the accuracy of 13 INFUSE Bone Graft clinical trials. According to the article, these trials included 780 patients but did not report a single adverse event. They suggested that the actual rate of adverse events was somewhere between 10% and 50%. The article also alleged that these trials were favorable to the device because Medtronic had paid the doctors conducting the trials.
The negative studies continued in June 2011 when it was found that 7% of men, treated with INFUSE, experienced retrograde ejaculation, a condition where semen enters the bladder, which causes male sterility. In an effort to obtain legitimacy, Medtronic paid Yale researchers to conduct a study completely independent of the company’s control. The study concluded that the “[INFUSE Bone Graft] has no proven clinical advantage over [traditional] bone graft and may be associated with important harms.”
What Has The Government Done About this Device?
Recently, Medtronic was the subject of an investigation by the Senate Finance Committee. The Committee investigated the financial ties between the company and doctors, who were conducting medical studies and writing journal articles.
The investigation alleged that the company paid doctors $210 million over the course of a 15-year period. The Committee stated that “Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants, who received significant amounts of money.” Additionally, company e-mails showed the company concealed adverse events.
Timeline Of Events And INFUSE Bone Graft Lawsuits:
- July, 2002 The FDA approves the Medtronic INFUSE Bone Graft device.
- August, 2011 A Florida woman filed a lawsuit alleging that she was implanted with the device using the off-label posterior approach. The device caused uncontrolled bone growth which compressed her spine causing severe pain.
- March, 2012 Medtronic settled a shareholder lawsuit for an $85 million settlement. Investors claimed that the company made misleading statements about the INFUSE Bone Graft.
- December, 2012 A Medtronic INFUSE Bone Graft lawsuit is filed by a Virginia man, who was implanted with the device using an off-label approach in 2003, and subsequently suffered disabling nerve damage in his spine.
- June 19, 2013 Medtronic paid approximately $2.5 million to have two independent studies conducted by researchers. Both studies found that INFUSE is not better than a traditional bone graft surgery, but that it may lead to higher risks such as cancer.
- May 6, 2014 Medtronic announced that they will settle approximately 950 Infuse bone graft lawsuits for a sum of $22 million. Also, in recognizing that they have over 3,000 more claims to resolve, they decided to set aside an additional $120-140 million.
- October 15, 2014 The Star Tribune stated that the outcome of a class action lawsuit involving Medtronic’s INFUSE Bone Graft is likely to lead to thousands more personal injury claims.
- January, 2015 The FDA released a warning that children face increased safety risks if INFUSE or other bone graft substitutes are used in their spinal surgery.
There are hundreds of lawsuits being filed against Medtronic right now, and it is important to make a claim before the money that has been set aside for claims runs out.
Why Contact Us?
If you or a loved one has suffered injuries related to the INFUSE Bone Graft, you could be entitled to compensation for medical bills, lost income and pain and suffering, among other losses. Our law firm works with some of the more experienced Medtronic INFUSE Bone Graft lawyers in the country, who can file a lawsuit on your behalf. There are no legal fees until you receive a settlement or award for your injuries. Contact us, toll free, at 1-800-992-6878 for a free (no obligation) case evaluation, or fill out a contact form on our website.