The Amplify implant is designed to treat degenerative disc disease in the lower backs of patients, and works with a genetically engineered protein, recombinant bone morphogenetic protein-2 (rhBMP-2), to instigate new bone growth. However, the findings of clinical trials on the device’s effectiveness seem to suggest that it may be linked to an increase in cancer among recipients.

The FDA Orthopaedic and Rehabilitation Devices Advisory Panel will meet this week to decide whether to recommend Amplify for approval. The FDA will then decide in the coming months whether the device should be available in the United States. Although the regulatory agency is not required to follow the recommendations of their advisory panel, it usually does.

In an FDA report (pdf) given to the panel before the meeting, FDA officials have raised concerns about clinical trials that indicate about 5% of Amplify patients developed cancer after five years, compared to only a 1.8% cancer rate among a control group that had more traditional lower back spine surgery. However, the cancers were all different types and Medtronic says that the number is not clinically significant. The FDA is asking the panel to make its own evaluation on the importance of the numbers.

The genetically engineered protein, rhBMP-2, is also used in the Medtronic InFuse bone graft. While meant to be used to replace damaged spinal disks in the vertebrae, that treatment is often used off-label in cervical fusion surgery.

Use of the Medtronic Infuse Bone Replacement Graft during cervical fusion surgery has been associated with a high rate of serious complications involving compression of the airway and nerves. Given the close proximity of the cervical spine to the airway, a number of patients who received the bone stimulator have experienced difficulty breathing, speaking or swallowing between 2 to 14 hours after surgery, which could lead to respiratory arrest or death.

A number of Medtronic InFuse lawsuits have been filed against the company, at least one of which is a wrongful death claim. However, the protein, known as BMP in InFuse, is used in a very different manner in the Amplify implant.

Medtronic’s spinal implant division brought in $3.5 billion for the company last year. Analysts expect the Amplify device to increase that amount by about $175 million in the first year, if approved. However, some say that the device only has about a 40% chance of approval.

Medtronic has been accused of marketing the Infuse Bone Graft off-label for use in the cervical spine, even though it is only approved for use in the lumbar spine and for some dental procedures, and reports suggest that it could cause serious and potentially life-threatening injuries.

The Infuse bone replacement graft is a man-made, liquid bone stimulator that is implanted between spinal vertebrae. It contains Bone Morphogenetic Protein (BMP), which is a bioengineered protein that encourages bone growth to replace damaged spinal disks.

In what is believed to be at least the third Medtronic Infuse Bone Replacement Graft lawsuit filed in the United States, Paul Antonelli and his wife allege that use of the product during his cervical spine fusion caused him to suffer severe swelling in the neck and throat, which impacted his ability to breath and led to the an emergency tracheotomy after surgery.

The lawsuit was filed against Medtronic, Inc. and Medtroonic Sofamor Danek USA, Inc. in the U.S. District Court for the Southern District of New York.

Use of the Medtronic Infuse Bone Replacement Graft during cervical fusion surgery has been associated with a high rate of serious complications involving compression of the airway and nerves. Given the close proximity of the cervical spine to the airway, a number of patients who received the bone stimulator have experienced difficulty breathing, speaking or swallowing between 2 to 14 hours after surgery, which could lead to respiratory arrest or death.

In December 2008, a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman, Shirley Nisbet, who died after going into a coma caused by respiratory arrest following surgery. The Infuse bone replacement lawsuit alleged that Medtronic failed to warn about the risks associated with use of the device in the neck, and claims that Medtronic actively encouraged the off-label use which has not been approved by the FDA.

According to reports on Minnesota’s Finance and Commerce, another Medtronic lawsuit was filed earlier this month by Mary Selke, a Texas woman who claims that the use of the Infuse bone graft in her neck caused her to suffer an inability to breath and swallow, requiring emergency surgery.

The U.S. Department of Justice is currently investigating Medtronic’s promotion and marketing of the Infuse bone replacement and whether federal laws have been violated by pushing use in areas of the spine which they have not established are safe or effective.

Other Medtronic lawsuits are likely to be filed in the coming months, as Infuse bone replacement lawyers are investigating and reviewing potential cases on behalf of individuals who experienced complications after use of the bone graft in the neck.

The Medtronic Infuse bone graft is a liquid bone stimulator that includes a biologically engineered protein known as the bone morphogenetic protein or BMP. The product, which is soaked in a sponge-like material and implanted in a small cage between spinal vertebrae, encourages bone growth and helps replace spinal disks that are damaged.

Since receiving FDA approval in 2002, the Medtronic Infuse bone graft has been widely used in spinal fusions and some dental procedures, generating sales of over $3 billion. However, it has recently emerged that a large amount of the sales have come from off-label uses that have not been approved by the FDA as safe or effective, such as in the cervical spine or neck, which has been associated with possible swelling of the neck and compression of the airway or nerves.

Because the cervical spine and the airway are located in close proximity, the use in this region has led to a number of reported Infuse Bone Graft complications including individuals experiencing difficulty breathing, difficulty swallowing, trouble speaking, nerve damage, swelling of the neck, respiratory failure and death.

Medtronic has also recently disclosed that they face an investigation by the U.S. Department of Justice over alleged off-label promotion and marketing of the Infuse Bone Graft, which would violate federal laws and expose the company to substantial fines.

The Medtronic Infuse Bone Graft class action alleges that between November 19, 2007 and November 17, 2008, the company and its executives violated federal securities laws by providing repeated false and misleading information to investors about their flagship product.

The plaintiffs allege that the company concealed or failed to disclose the extent to which revenues were dependent on applications of the Infuse Bone Graft that were not approved by the FDA, and which Medtronic had not established as safe or effective. They also indicate that the company failed to disclose that a significant number of patients who received the Medtronic Infuse Bone Graft for an unapproved use, were suffering severe medical complications.

As result of the false statements, the investors indicate that the company’s stock was trading at inflated prices and as information about these Medtronic Infuse Bone Graft problems have emerged, the stock has declined drastically.

At least one Medtronic Infuse Bone Graft wrongful death lawsuit has already been filed against the company by the family of a California woman who died from respiratory arrest following the use of the bone stimulator in her neck. In addition, product liability lawyers are investigating and reviewing other potential Infuse bone stimulator lawsuits on behalf of individuals who have experienced complications.

The Medtronic Infuse bone graft consists of a man-made liquid bone graft that includes a bioengineered protein called bone morphogenetic protein (BMP).

The graft is used to encourage bone growth and replace damaged spinal disks by filling inter-vertebral gaps. It is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.

The bone stimulator was introduced in 2002, but the FDA has only approved for use in the lower-back and for some oral and dental procedures. Although Medtronic has never submitted data establishing that it is safe for use in other areas of the spine, the Infuse bone graft has been widely used off-label in neck fusions.

There have been over 200 reports of serious complications associated with the use of the Medtronic bone graft, particularly when it is used off-label in the cervical spine. Given the close proximity to the airway, use of the bone stimulator during neck surgery has resulted in problems such as difficulty breathing, swallowing and speaking. It can cause swelling of the neck, which may compresses the airway and the nerves, potentially resulting in death.

The wrongful death lawsuit was filed on December 2, 2008, in the United States District Court for the Central District of California in Los Angeles by the family of Shirley Nisbet. The complaint names Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. as Defendants.

Nisbet died as a result of respiratory arrest which she alleges was caused by the use of the Infuse bone graft in her neck. The lawsuit claims that a Medtronic representative encouraged the surgeon to use the Infuse bone graft in the neck surgery, and was present in the operating room during her surgery.

The FDA issued a health warning in July 2008 warning about the off-label use of bone stimulators in the cervical spine, which was several weeks before Nisbet’s surgery. The Infuse lawsuit alleges that Medtronic was well aware of the serious risk of complications associated with the use of the bone graft in the cervical spine at the time of her surgery.

Last month, Medtronic disclosed that the U.S. Department of Justice is investigating their marketing and promotion of the Infuse bone graft, as several allegations have been raised that indicate the company encouraged off-label use in the neck.

Although surgeons are permitted to use approved medical devices for un-approved uses, the manufacturer is not allowed to promote or encourage those off-label uses which they have not determined to be safe. If the Justice Department finds that Medtronic violated the federal law in their promotion of the Infuse bone graft, the medical device company could face substantial fines.

The Nisbet case is believed to be the first Medtronic Infuse bone graft lawsuit filed in the United States as a result of the use of the stimulator during neck surgery.

The Medtronic Infuse bone graft is a synthetic liquid spinal implant that helps bone growth. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).

The Infuse bone implant is surgically placed between spinal vertebrae soaked in a sponge-like material and enclosed in a metal cage. BMP causes bone growth that replaces damaged disks by filling the gaps between vertebrae.

The FDA has only approved the Infuse bone stimulator for use in the lower lumber spine, as Medtronic has not provided data establishing that it is safe and effective in other areas of the spine. However, since it was introduced in 2002, the medical device has been widely used off-label in the cervical spine.

According to the Wall Street Journal, the United States Department of Justice is probing Medtronic’s marketing and promotion of the device. There have been a number of reports regarding off-label promotion and actions by Medtronic which encouraged surgeons to use the Infuse bone stimulator for un-approved uses, which would violate federal law.

While healthcare providers are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such off-label uses that have not been established as safe and effective.

The FDA has received about 280 reports of Infuse bone graft side effects, and about 75% of the reports involved off-label use of the implant, particularly in the cervical spine. The close proximity of the cervical spine to airway structures has led to a number of serious complications, many of which required emergency medical treatment.

In July 2008, the FDA issued a public health notification warning against the off-label use of the Infuse recombinant human hone morphogenetic protein in the neck, or cervical, part of the spine. The FDA highlighted reports of cervical spine bone graft problems, which included breathing issues, difficulty speaking and trouble swallowing caused by swelling of the neck which compressed the airway and nerves.

According to the FDA, the life-threatening cervical bone graft complications have typically occurred within 2 to 14 days after surgery, with some individuals requiring insertion of feeding tubes, tracheotomies, anti-inflammatory drugs and additional surgery to drain the implant site. 

A group of surgeons from North Carolina recently presented data at a spine conference that found a 21% complication rate with bone grafts or collagen in conventional fusion surgery, as compared to a complication rate of 59% in cervical spine surgeries using Infuse. The study had 76 patients and was carried out between July 2005 and December 2007.

While most recent Justice Department probes of off-label promotion have focused on pharmaceutical products, the investigation could lead to hefty fines if Medtronic is found to have violated federal law.

Over the past few years, Eli Lilly & Co. has faced a similar Justice investigation related to their marketing and promotion of the antipsychotic drug Zyprexa. According to a New York Times report the company could pay fines and restitution in excess of $1 billion for their off-label promotion for uses other than schizophrenia, while downplaying side effects of Zyprexa like weight gain, diabetes and other metabolic changes.

MEDTRONIC INFUSE LAWSUIT STATUS: Potential legal claims are being investigated and reviewed for individuals who experienced cervical spine fusion problems involving the device.

>>REVIEW A POTENTIAL MEDTRONIC INFUSE BONE STIMULATOR LAWSUIT WITH A LAWYER<<

 
MANUFACTURER: Medtronic, Inc.

OVERVIEW: The Medtronic Infuse bone graft is a man-made liquid bone graft that includes a biologically engineered protein called bone morphogenetic protein (BMP), made by Wyeth.

The bone stimulator is used to encourage bone growth and replace damaged spinal disks by filling the gaps between vertebrae. The Infuse is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.

Since it was approved by the FDA in 2002, the Medtronic bone graft has been widely used during spinal fusions and has generated sales of over $3 billion.

While the Infuse bone graft is only approved for use in the lower lumber spine, it has been widely used off-label in the cervical spine which has been associated with life–threatening problems, such as:

• Difficulty Breathing
• Difficulty Swallowing
• Difficulty Speaking
• Swelling of the Neck
• Compression of Airways
• Nerve Damage
• Death

MEDTRONIC INFUSE CERVICAL SPINE FUSION SIDE EFFECTS: The close proximity of the cervical spine to the airway has caused a number of serious complications associated with use of the Medtronic Infuse bone graft in the cervical spine or neck fusions.

According to recent research presented by a group of North Carolina surgeons, the Medtronic Infuse cervical spine complication rate is about 59%, compared with a complication rate of 21% for bone grafts or collagen used in conventional cervical spine fusions.

The FDA issued a warning to healthcare providers in July 2008 highlighting at least 38 reports of cervical spine fusion problems with the bone morphogenetic protein in the Medtronic Infuse. The serious and life-threatening complications caused by airway compression have required a number of patients to receive respiratory support, tracheotomies, insertion of feeding tubes anti-inflammatory medications and additional surgery.

Most of the Medtronic Infuse bone stimulator complications have occurred within 2 to 14 days after surgery as the neck swells, compressing the airway and nerves.

JUSTICE DEPARTMENT MEDTRONIC INFUSE INVESTIGATION: On November 19, 2008, Medtronic disclosed that the Justice Department is probing their Infuse bone graft marketing and promotion to doctors and actions taken by the company that encouraged off-label use that has not been approved or determined to be safe by the FDA.