INFUSE Bone Graft Overview
INFUSE Bone Graft is a procedure created by Medtronic, that employs a synthetic protein during spinal and other types of surgery to encourage new bone growth. Infuse Bone Grafts have been used in millions of procedures but may have caused serious complications in many patients.
Infuse Bone Graft is a medical technique used to alleviate spinal problems by encouraging the natural process of bone formation. The Infuse Bone Graft is a two-part system where bovine collagen is used to create a framework for new bone tissue to form. The technique works by placing a human recombinant morphogenetic protein into a bovine collagen mold, or graft. In the bone graft, protein is released while replacing the degenerated bone tissue.
The Infuse Bone Graft was designed to be a replacement to the conventional idea of using donated material from the patient’s bones. This way, patients would be able to undergo a quicker bone graft surgery with minimized inconvenience, pain, and recovery time.
Infuse Bone Graft lawsuits have been filed against the product’s manufacturer, Medtronic. The product was approved for use in 2002 for specific spine and jaw surgeries. However, it was illegally promoted for “off-label use” by the manufacturer Off-label uses of the Infuse Bone Graft have resulted in a series of class action Infuse Bone Graft lawsuits.
INFUSE Bone Graft Controversy
According to a study in The Journal of the American Medical Association (JAMA), there was a 15-fold increase in the number of spinal fusion surgeries from 2001 to 2007. This was apparently a direct result of the Infuse Bone Graft since doctors no longer needed to perform “bone harvest” surgeries before spinal fusion. During this time, Medtronic Inc. spent millions of dollars in consulting fees and royalty payments. Several officials believe this was an effort to suppress safety concerns from the Infuse Bone Graft.
The Infuse Bone Graft appears to be safe for use in lower back, or lumbar, surgery, however the procedure has been used in fusions involving the cervical spine, or vertebrae of the neck which may have resulted in complications. This is considered an “off-label use,” since the Infuse Bone Graft is not federally approved for use in the cervical area of the spine.
Numerous injuries may have resulted from Medtronic illegally promoting off-label uses of the Infuse Bone Graft. As a result, Medtronic faces a number of Infuse lawsuits.
INFUSE FDA Warning
Infuse is a recombinant human bone morphogenetic protein (rhBMP) produced by Medtronic Inc. This bone grafting technique is used to treat patients with bone deteriorating conditions associated with degenerative disc disease, skeletal trauma, and oral maxillofacial surgery. Infuse is a popular alternative to other bone graft techniques because it does not require the harvesting of the patient’s own bone for grafting. Instead, it creates a platform for the bone to grow on, while stimulating the patient’s natural bone growth. This is meant to reduce pain and recovery time.
INFUSE FDA Approval
In July of 2008, Infuse was approved for the following:
- Open tibia shaft fractures
- Certain types of oral and maxillofacial surgery
- Treatment of degenerative disease, affecting the lumbar portion of the patient’s spine
INFUSE FDA Warnings
The U.S. Food and Drug Administration (FDA) issued a statement in July 2008 regarding life-threatening complications associated with Infuse bone grafts. Between 2004 and 2008, the FDA had received 38 cases of patients experiencing complications during their Infuse cervical spine fusion treatment. At the time, Infuse was not approved for cervical spine fusion. The Infuse FDA warnings were specifically targeted towards this unapproved use of Infuse.
Life-Threatening INFUSE Risks
The complications in the Infuse FDA warnings included the constriction of airways and nerves due to the swelling of throat tissues. Other reported problems involved difficulty breathing and swallowing, described in the Infuse FDA warning statement as “severe dysphagia.” The anatomical proximity of the cervical spine to the airways contributed to the severity of the Infuse side effects.
The majority of these life-threatening symptoms detailed in the Infuse FDA warnings were experienced between 2 and 14 days following the procedure. In the event of airway constriction, patients often required medical intervention. Intubation, anti-inflammatory medication, tracheotomies, and additional surgery were often needed to treat the complications profiled in the Infuse FDA warnings.
The Infuse FDA warnings further suggested that patients treated with any recombinant human bone morphogenetic protein (rhBMP) in the cervical spine should know:
- The signs and symptoms of airway complications. This includes difficulty breathing or swallowing, swelling of the neck, tongue, mouth, throat, and shoulders or upper chest area.
- To seek immediate medical attention at the first sign of an airway complication.
- To be especially watchful between 2 and 14 days after the Infuse cervical procedure, when airway complications would be most likely to occur.
INFUSE Senate Investigation
In 2010, a collaborative investigation between the Journal Sentinel and MedPage Today found that physicians with financial ties to Medtronic reported suspiciously optimistic results with Infuse treatments. The reports occurred during the period prior to the FDA’s approval of the procedure in 2002. Doctors financially connected to Medtronic recorded significantly better Infuse results than doctors that worked independently of the company’s financial influence.
In 2011, the United States Senate launched a formal investigation of Medtronic’s possible involvement in the publishing of biased articles. These biased articled falsified information regarding the potential safety issues of Infuse treatments. Physicians with known financial ties to Medtronic published articles omitting serious Infuse risks and side effects associated with treatment.
In the years leading up to the Infuse Senate investigation, side effects missing from Medtronic-affiliated doctors included:
- Male sterility
- Neurological complications, due to entropic bone development
- Radiating leg pain
- Potentially fatal swelling of the throat and neck
INFUSE Senate Investigation Results
After a 16-month investigation of Medtronic’s financial records, the Infuse Senate investigation yielded evidence that Medtronic had been privately paying physicians to write articles promoting Infuse products. Over a 15-year period, Medtronic paid $210 million to these doctors for confidentially promoting their products and was estimated to have profited by $900 million from the Infuse Bone Graft system.
The medical authors promoted Infuse by downplaying health risks, while dismissing other alternative bone graft treatments. Infuse Bone Graft lawsuits are largely based on financial ties between Medtronic and researchers supporting the technique. At the Infuse Bone Graft lawsuits, researchers claimed there were no risks but developing health problems suggest otherwise.
Grassley – Kohl Physician Payments Sunshine Act
The findings by the Infuse Senate Investigation emphasize the Grassley-Kohl Physician Payments Sunshine Act. This act was included in the Patient Protection and Affordable Care Act of 2009, which was signed into law on March 23, 2010. The Physician Payments Sunshine Act demanded that royalties paid to physicians by corporate businesses must be recorded and made public starting January 1, 2012.
INFUSE Side Effects
The Infuse Bone Graft is approved by the Food and Drug Administration (FDA) for use in dental bone grafting procedures, open fractures of the tibia, and Degenerative Disc Disease. However, it is also used “off-label” (not approved by the FDA) for surgeries of the neck. Off-label uses of the Infuse Bone Graft have caused Infuse side effects for many patients.
Infuse side effects come as a result of the artificial protein inflaming nearby tissue. The material must be inserted properly, or it might leak and cause bone growth outside of the surgical site. There were over 200 adverse events that were reported to the FDA for off-label uses causing harmful Infuse side effects.
Senators from the Senate Finance Committee contacted Medtronic about three specific Infuse side effects. Abnormal bone growth, swelling of the neck and throat, and sterility were frequently reported Infuse side effects. However, patients have mentioned numerous other problems from Infuse side effects.
Common INFUSE Side Effects
Among other symptoms of the Infuse Bone Graft, the conditions developed can affect bones and muscles, heart, and lung systems, and cause nervous system complications. The effects from the Infuse Bone Graft can affect areas near the surgery site or can cause other bodily harm.
The Infuse side effects include:
- Swelling and inflammation
- General discomfort
- Difficulty swallowing, speaking or breathing
- Uncontrolled bone growth
- Nerve injuries or paralysis
- Radiating pains in arm or leg
- Male sterility due to retrograde ejaculation
- Urogenital injuries and swelling
- Kidney failure
- Pulmonary embolism
- Tears in spinal cord tissue, or dura
- Allergic reaction
- Excessive bleeding
- Vascular complications
In some cases, severe side effects or complications of INFUSE may be life-threatening.
INFUSE Bone Graft Lawsuits
Medtronic, manufacturer of the INFUSE bone graft, agreed to pay $85 million as a settlement of a shareholder lawsuit. Accusations allege that Medtronic is guilty of making misleading statements about the Infuse Bone Graft. This illegal marketing strategy is believed to have increased sales by approximately 85 percent.
Medtronic has faced more than 10,000 lawsuits for complications caused by the treatments including infections, sterility, and bone problems. The company set aside more than $300 million to settle many of the INFUSE Bone Graft Lawsuits.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.