Medtronic INFUSE Bone Graft Lawyer - d'Oliveira & Associates, P.C.

The use of Medtronic INFUSE Bone Graft has been linked to cancer, throat swelling, and other side effects. We are currently working with some of the leading defective medical device attorneys in the United States. A claim and/or Medtronic INFUSE Bone Graft lawsuit can be filed on your behalf and there is no fee until you receive an award or a Medtronic INFUSE Bone Graft Lawsuit settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.

Medtronic INFUSE Bone Graft was approved by the FDA in 2002, and it is manufactured by Medtronic. The INFUSE is used in back surgery to grow bone in your spine. FDA reports have stated that INFUSE was reported 280 times by 2008 by patients developing neck swelling, trouble swallowing, several different kinds of cancer and sexual side effects. Post-surgical complications linked to INFUSE Bone Graft include:

• Cancer – skin (melanoma), thyroid, breast, prostate, lymphoma, pancreatic, ovarian, stomach, leukemia, laryngeal and lung cancers.
• Sexual Side Effects – including sterility and uro-genital injuries and other sexual complications in males.
• Uncontrolled Bone Growth – INFUSE has been linked to ectopic or uncontrolled bone growth in patients at or near the surgical site (one study said that 75% of INFUSE patients experienced this complication).
• Swelling of the Neck or Throat – including trouble swallowing, breathing, and talking.
• Nerve Injuries – including chronic and severe radiating pain in the arms or legs (such as radiculitis, radiopathy or neuritis).

The INFUSE Bone Graft was approved for use in fusing bones in the lower part of the back (the lumbar spine, from the L-2 to S-1 vertebrae) of patients suffering from back pain. However, it has been used off-label to fuse bones in the upper part of the back and neck (the cervical spine). This has led to various cancers, sexual side effects, uncontrolled bone growth, nerve injuries and more. The National Center for Biotechnology Information, part of the US Government’s National Institutes of Health, reported that nearly 2 of every 3 uses of the Medtronic INFUSE Bone Graft were off-label.

How do I find out if I received a Medtronic INFUSE Bone Graft?

In order to have a claim based on severe side effects from receiving a Medtronic INFUSE Bone Graft, you need to be sure that you have received that implant. Here are some tips to make sure that you have received this dangerous device.

Not all spinal fusion surgeries use the Medtronic INFUSE Bone Graft

If you had a spinal fusion surgery, you may or may not have used the Medtronic INFUSE Bone Graft. Chances you received a Medtronic INFUSE Bone Graft can increase if some or all of the following are true:

• You did not have bone from another part of your body removed and placed in your back.
• You did not receive bone from a cadaver or “demineralized bone matrix” during your procedure.
• Your doctor talked to you about receiving a “BMP” or “Bone Morphogenic Protein” implant.

How do I find out if the Medtronic INFUSE Bone Graft was used in my surgery?

There are some ways that you can find out how your spinal fusion surgery was performed:

• If you still have the paperwork you received around the time of your surgery, it should tell you how your fusion was performed.
• Contact the hospital and ask for a copy of the surgical report for your surgery. Have the date your surgery was performed and the name of the surgeon on hand.
• Contact your primary care physician. If you don’t remember the name of the surgeon or the date of the surgery, they may have it in your records.

How Do I Know if I Have a Claim Because of a Medtronic INFUSE Bone Graft?

The INFUSE Bone Graft was licensed by the US Food and Drug Administration (FDA) for use in spinal fusion surgeries in July 2002. It was only supposed to be used in a specific kind of procedure called Anterior Lumbar Interbody Fusion (ALIF).

During the ALIF procedure, a small incision is made on the front of the torso and the front of the spine is accessed through the abdominal cavity. This allows the surgeon access to the spinal column without having to remove bone. The damaged disc is partially removed from between the vertebrae, two of the INFUSE cages are implanted using the threads around the device to screw it between the bones.

You May Have a Claim if you have a Medtronic INFUSE Bone Graft that:

• Was implanted through an incision on your back or side, instead of through your stomach.
• Was used in part of your middle or upper back – the INFUSE Bone Graft is licensed to be used only between the L2 and S1 vertebrae.
• Has caused unwanted bone growth, cancer, repeat or emergency surgeries.

Medtronic Infuse Bone Graft Serious Injuries

Approved in 2002 by the Food and Drug Administration (FDA), the spinal fusion bone graft INFUSE was initially met with a safety record that appeared too good to be true. Studies sponsored by the maker of the INFUSE bone graft, Medtronic, showed that among hundreds of users, there had not been a single incident of adverse side effects. As it turns out, this was too good to be true.

In a 2011 article in The Spine Journal, a reputable source in the industry, many of the studies demonstrating and advocating the use of Medtronic were examined. It appeared to the authors that many of the studies did their best to minimize the risk associated with the INFUSE bone graft.

Some off-label use has been linked to injuries from the INFUSE bone graft. Also, the bone graft has been associated with major injuries regardless of how it has been used. These side effects can range from mild injuries to serious and life threatening complication.

One of the major concerns for those who have been implanted with the Medtronic INFUSE bone graft is overgrowth or uncontrolled bone growth. The protein included in the device stimulates the body to grow new bone to help fuse spinal bones. Unfortunately, many incidents have been reported in which the bone has not stopped growing. This is dangerous anywhere in the body, but particularly if the device has been implanted off-label in the cervical spine. Bone overgrowth in that part of the body can lead to trouble breathing, eating, and talking.

There has also been a risk of various types of cancers linked with use of the INFUSE bone graft. Among these cancers are breast cancer, thyroid cancer, pancreatic, ovarian, stomach, and lung cancers, and increased risks of both melanoma and leukemia.

The growth of bone has also been a risk factor when in contact with nerves. Since the bone is growing so close to the spinal cord, certain nerves can be affected. Increased numbness and pain have been reported after use surgeries using the INFUSE bone graft. Nerves have also been related to risks of infertility in men because of certain nerves that cause certain ejaculatory malfunctioning.

All of these injuries are serious and may pose a very real risk. These risks may be even greater if this product has been used off-label in the cervical spine (neck) instead of the lumbar spine (lower back).  If you have experienced any of these injuries, please don’t hesitate to contact a Medtronic INFUSE bone graft lawyer.

Medtronic Facing Whistleblower Lawsuit Over Payments to Doctors

Medtronic, maker of the widely used and very popular INFUSE bone graft implant, has been the target of several whistleblower lawsuits in the past few years. These kinds of lawsuits allow an employee with knowledge of wrongdoing on the part of a company to bring a suit for the government. These cases have been aimed at exposing some of the alleged abuses by Medtronic in bringing its INFUSE bone graft to market.

The INFUSE bone graft was designed to be used in spine surgery where two bones are fused together to help reduce pain or correct a curvature of the spine. Studies that were conducted before the item was brought to market investigated the safety of the medical device. Several of these showed that the INFUSE bone graft was so safe that no adverse events appeared in the trials. A later study demonstrated that these trials were flawed to both minimize the risks of using the INFUSE bone graft. The studies also tended to exaggerate the risks involved with using the more common competitor, the iliac crest bone graft (ICBG) method of harvesting bone from the hip to fuse the spine.

One of the whistleblower lawsuits dealt with accusations that Medtronic poured money into these studies to make its product appear safer than it was. One of these doctors – the one who designed the only device approved to deliver the INFUSE bone graft – reportedly received upwards of $25 million from Medtronic since 2003. This same doctor was installed as the editor of a prestigious medical journal that focuses on spine surgeries. This same journal later printed several articles praising the INFUSE bone graft, its safety, and its versatility. The articles advocated many uses for the INFUSE bone graft, including off-label use of the device in the cervical spine (in the neck, as opposed to the lower back) or by the unapproved posterior route (through the back, instead of through the front of the torso).

Other suits have also been filed. One shareholder’s derivative action – where shareholders sue board members on behalf of the company – also alleged that Medtronic had lied about the safety record of INFUSE in studies. The suit alleged that Medtronic had downplayed risks of using INFUSE in order to artificially inflate the stock price of Medtronic. This suit was settled in April 2012 for a reported $85 million – though Medtronic did not admit fault for publishing, or allowing to be published, misleading safety information.

Critical Study Reviews the Hormone in INFUSE Bone Graft

Produced by medical device manufacturer Medtronic, the INFUSE Bone Graft was approved by the Food and Drug Administration (FDA) in 2002. It contains recombinant human bone morphogenetic protein-2 (rhBMP-2), a hormone that stimulated bone growth. Instead of harvesting bone from the iliac crest, the outer edge of the hip bone, INFUSE allows the patient to grow new bone without having to use bone from another part of the body.

Studies before the approval of INFUSE by the FDA seemed to show that it was far safer than harvesting bone from the hip (a process known as iliac crest bone graft, or ICBG). In fact, among the 780 participants in INFUSE studies both before and after approval seemed to show that there was less than a 0.5% chance of developing an adverse reaction because of rhBMP-2. By contrast, these same studies showed a 40-60% chance of adverse reactions with ICBG.

Studies after approval advocated off-label use of the INFUSE device, which was approved solely for use in anterior lumbar interbody fusion (ALIF). ALIF involves an approach to the spine from the front through an incision usually on the front of the torso, usually in the area of the navel. It was only supposed to be used in fusions in the lumbar spine – the lower back – because of the size of the device. Other studies, however, advocated use of INFUSE in posterior lumbar interbody fusion (PLIF), in which the spine is approached from the back, and also in other parts of the spine such as the cervical spine in the neck. These studies to continued to show a 0% risk of adverse effects.

These very low adverse reactions prompted a medical study – published in the Spine Journal (the “Spine Journal study”)– into whether these statistics were correct. Also warning of possible irregularities in the studies was the language used by researchers. More than one study made statements to the effect that “[t]here were no unanticipated device-related adverse affects.” This left the possibility open to adverse effects that had been anticipated, but were still very serious, or other injuries that the researchers had not considered “device-related.”

What is also possible is that there were anticipated adverse events that were anticipated and observed, but were not listed among the “unanticipated device-related adverse effects.” The authors of the critical study focused on five different areas of that one prior study anticipated:

• Overgrowth & uncontrolled bone growth
• Movement of the bone graft
• Inflammation, infection, or other problems at the site of the surgery
• Nerve damage
• Potential to cause cancer

The seemingly trouble-free studies put some on notice. The authors of the Spine Journal study compared a 2009 study showing no adverse events to FDA data covering the same trial. Despite the results of the trial, FDA documents covering the same trial showed that 16% of the patients receiving the INFUSE bone graft suffered adverse events leading to pain the back and leg. This is three times the number of adverse events that happened in the control group using the traditional ICBG group.

Another adverse event that often went unreported was the risk of both urogenital/bladder problems. Again, while there was little to no reporting of adverse events involving genital or bladder problems, the FDA safety and effectiveness summary told a very different story. According to the FDA study, the risk for these kinds of complications was 7.9% with the rhBMP-2 contained in the INFUSE bone graft, while traditional ICBG was associated with a 3.6% risk.

Infections as an adverse effect of the rhBMP-2 were also not reported in the 13 original studies. The FDA summary, however, showed a different study. There was almost an identical number of early-onset infections with INFUSE-type products and ICBG procedures – both at about 3.9%. However, there was a profound difference between infections within the first year. While ICBG showed a much lower risk of infections – 1.4%, the rhBMP-2 group showed a whopping 4.2% risk of infections, three times the risk.

Medtronic-Funded Medical Studies Showed Unnaturally Lowered Risk

The medical device manufacturer Medtronic placed its INFUSE Bone Graft onto the market in 2002 after FDA approval. INFUSE contains a hormone known as recombinant human bone morphogenetic protein-2 (rhBMP-2). It was originally believed that rhBMP-2 devices like INFUSE were much safer than the traditional iliac crest bone graft (ICBG) treatment, which involves harvesting bone from the hip to help fuse spinal bone. Thirteen studies were conducted between 2002 and 2009, with all but one of them receiving funding from Medtronic. A critical study in the Spine Journal (the “Spine Journal study”) examined the influence of this money and how it appears to have swayed the results of these studies.

Of the original 13 studies that showed no adverse effects, the Spine Journal study showed that there was a potential for conflict of interest. One of the 13 studies did not say whether or not it had received funding from any outside group. The other 12 studies, however, had “financial association” with Medtronic. This amount of assistance from Medtronic averaged between $12 million and $16 million dollars (with one study receiving as much as $23.5 million).

Considering how much Medtronic poured into these studies, perhaps it should come as no surprise that there are accusations that these studies were improperly handled. One of the strongest accusations is that the study improperly overestimated the risks of complications with ICBG than with the rhBMP-2 based INFUSE bone graft. This may have been consciously done to attempt to make the INFUSE bone graft appear to be a safer alternative to traditional methods that involve harvesting bone from elsewhere in the body. This is believed to have led to overestimating the harm ICBG could cause, which has since been show not to be the case with FDA statistics that show much greater risk of harm with rhBMP-2 implants.

Early on, because of these studies, rhBMP-2 implants like INFUSE gained the reputation of having a perfect – or at least nearly perfect – safety record. Because of this reputation, it is possible that doctors may have felt very confident using this device for off-label uses. These off-label uses were also advocated in some of the studies that reinforced the false reputation for safety. When used off-label, however, the rh-BMP-2 hormone in INFUSE could actually lead to what the Spine Journal study called “potentially catastrophic outcomes.”