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Bone grafting is a surgical procedure performed on patients who have bone or joint related problems. Bone grafts aim to stimulate bone growth or to replace broken bones in the vertebrae or the spinal column to help bone repair.
There are three ways to go about bone grafting. The first is an autograft, where surgeons harvest bones from the same patient’s healthy bones, which is typically taken from the hip. As such, autografts are more costly and could pose more pain and suffering to patients because of its complex and multiple procedures.
Another form of bone grafting is an allograft, where instead of a surgeon harvesting a healthy bone from a patient, the bone is donated from another person. Allografts pose a risk of infection or disease to the recipient, in addition to the fact that the quality of the bone cannot be controlled.
Thus, synthetic bone grafts were invented. Initially deemed as a safer and superior alternative to autografts and allografts, over the years, some synthetic bone grafts have proven to be more troublesome because of its adverse side effects.
One of these synthetic bone grafts that pose high risks and danger to patients is the Medtronic INFUSE Bone Graft. This device is made out of concentrated proteins called recombinant human bone morphogenetic proteins, or rhBMP-2.
The Medtronic INFUSE Bone Graft system is actually comprised of two components: the rhBMP-2 mixed with sterilized water to form a solution, which is then applied to the second component: a sponge manufactured from cow collagen. The sponge is placed inside a pair of metal LT-CAGES, which are then implanted into the problem area.
It was in 2002 when the United States Food and Drug Administration first approved the Medtronic INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion device system for use in patients with degenerative disc disease, including slipped discs in the spine.
Its initial approval was only for the use of the surgical technique called anterior lumbar interbody fusion (ALIF). In 2004, the same medical device was approved by the FDA for use in open fractures of the tibia. The INFUSE Bone Graft was approved for the use as an alternative in sinus augmentations in 2007.
In spite of its approved uses, many surgeons have continued to use the medical device in off-label uses, which have added to the controversy against the company regarding the INFUSE Bone Graft.
Medtronic INFUSE Bone Graft
INFUSE Bone Graft is a synthetic medical device made out of concentrated proteins called recombinant human bone morphogenetic proteins (rhBMP-2), which is “a genetically engineered version of a protein everyone’s body produces naturally in small amounts to regulate bone growth and healing,” as per its manufacturer, Medtronic.
This Medtronic bone graft consists of two components: the synthetic rhBMP-2 – which comes in powdered form – mixed with sterilized water to form a solution.
The resulting solution is then applied to the sponge – manufactured from cow collagen – before it is placed inside a pair of LT-CAGES, a metallic device that looks like a thimble.
The whole system is the device implanted onto the spine, in between the vertebrae. The device keeps the vertebrae in place until the new bone can actually form. The sponge dissolves over time.
The United States Food and Drug Administration first approved the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion device system in 2002. The system is intended for use in patients with degenerative disc disease, including Grade I Spondylolisthesis, or slipped disc in the spine.
However, the bone graft had only been approved for use in the lower back or lumbar spine. The only FDA-approved surgical technique for use of this device is the anterior lumbar interbody fusion (ALIF). In this type of surgery, the doctor operates on the spine by going through the abdomen, as it minimizes injury to the back muscles and nerves.
It was only in 2004 when the FDA approved the bone graft system to be used in open fractures of the tibia. Come 2007, the device also obtained approval from the FDA for use as a bone graft alternative in sinus augmentations.
What is a Bone Graft?
Bone grafting is a surgical procedure done on patients who need solutions to bone or joint related problems. Bone grafting, or bone tissue transplants aim to place new bones or bone substitutes by implantation around broken bones or bone defects.
Additionally, Wikipedia describes bone grafting as: “a surgical procedure that replaces missing bone in order to repair bone fractures that are extremely complex, pose a significant health risk to the patient, or fail to heal properly.”
A bone graft can be taken from a patient’s healthy bone – called an autograft – or from a frozen, donated bone – an allograft. There are some cases in which a manmade or synthetic bone substitute is used in bone grafting.
During surgery, bone grafts are shaped before being inserted into and around the area it is to be placed in. Pins, plates, or screws are also used to keep the bone graft in place.
Bone grafts are typically used to: (1) fuse joints to prevent movement; (2) repair broken bones or fractures that have bone loss; (3) repair injured bones that have not healed; and (4) regenerate bones that have lost due to disease, infection or injury.
More and more people suffer from crippling back pain because of various kinds of degenerative diseases, or arthritis. In fact, approximately 84 percent of bone grafts are used in a surgical procedure called spinal fusion to alleviate back pain.
Surgeons in the United States actually perform 432,000 spinal fusions per year, with an average cost of over $34,000 for patients – for a single surgery. Doctors perform spinal fusions by merging together the individual damaged bones in the spine. After the procedure, the individual vertebrae then form into a single solid bone, thereby eliminating the irritation of spinal nerves.
Since its invention, synthetic bone grafts have been deemed a safer and better alternative for bone grafting simply because additional surgery is not needed. Donated bones carries the risk of infection or disease, in addition to the uncontrollable quality of the bone.
Meanwhile, autografts require a separate surgery in order to harvest the bone from the hip, which can come with complications such as pain at the harvest area, infection, bruising, and pelvic fracture.
Symptoms and Side Effects
Many have reported several adverse side effects related to INFUSE Bone Graft. These side effects include infection, male sterility, bone and nerve injury, urinary problems, and an increased risk for cancer.
Early clinical studies, including those of which reviewed by the FDA, showed that this medical device had the potential to inflame nearby tissues and bone, causing urinary problems and even fuel cancer growth.
BMP products are actually associated with a 43 percent higher overall complication rate. These adverse events were not published, until Dr. Carragee and his colleagues presented their 2011 review.
Some common side effects associated with the Medtronic bone graft are:
- Inflammatory reactions
- Cyst formation
- Back and leg pain
- Radiculitis (pain spreading through the spinal nerves)
- Implant displacement
- Retrograde ejaculation (occurs when semen makes its way into the bladder)
- Male sterility
- Osteolysis (bone tissue degeneration)
- Ectopic bone formation (unwanted bone in the spinal canal)
Furthermore, Dr. Carragee noted that the frequency of these complications are 10 to 15 percent higher than the actual reports. His study also noted that the risk of complications post-surgery associated with this bone graft are the same or even higher than autografts.
15 to 20 percent of people who have used the medical implant have reported back and leg pain. In fact, higher doses of the bone graft components pose higher risks of cancer development, as evidence has shown.
Lawsuits and Litigation
Because INFUSE Bone Grafts were first open to the market in 2002, it has been estimated that thousands of patients have already been injured by the defective device, along with the deceptive advertising on Medtronic’s part.
Many lawsuits have been filed in Arizona, because of the company’s many offices in Tempe, Arizona. Several of the lawsuit cases initially filed in Arizona state court were moved to the U.S. District Court for the District of Arizona, as per the device maker’s request.
The federal judicial panel has yet to consolidate all the INFUSE Bone Graft lawsuits into a multidistrict litigation. But as the number of lawsuits continue to grow, the court may soon do so to better manage the cases.
One of these patients was April Cabana, who filed a lawsuit against the device manufacturer in July 2011. April Cabana claims that the bone graft led to her severe back pain, making her unable to work due to her disability.
In October 2011, an unnamed surgeon also filed a lawsuit against Medtronic. The physician alleges that the bone graft caused severe injuries, leaving her health permanently damaged and unable to work. Furthermore, she reported symptoms such as burning pain on her right leg and debilitating pain, which made its way to her left side.
In March 2012, Medtronic revealed that it would be paying $85 million to its shareholders in a settlement agreement regarding the claims that led to the DOJ investigation and the consequent decrease in stock prices. However, the company denied any misrepresentation, omissions and other wrongdoings as stipulated in the settlement.
On May 2014, Medtronic settled $22 million for an estimated 1,000 lawsuits over their INFUSE Bone Graft. Additionally, reports say that the company also set aside another $140 million to fund even more claims in the thousands.
On April 14, 2015 Eileen Laferrera filed a product liability lawsuit against Medtronic, which was eventually brought to the U.S. District Court in the District of New Jersey, claiming that the off-label use (PILF surgery in October 2004) of the device maker’s product caused her to develop tumors in her heart and spine.
In the thousands of lawsuits filed against the device maker, plaintiffs are accusing the company of the following factors:
- Manufacturing a defective product
- Failure to warn
- Negligence for faulty product design and manufacturing
- Failure to recall the defective product and fix faulty design
- Fraud for misrepresenting the benefits of the device
- Concealing side effects
- Medical negligence
- Medical malpractice
- Breach of express and implied warranty
Furthermore, plaintiffs are also seeking to claim punitive damages following the company’s intended marketing of off-label uses for the product and concealing its side effects.
FDA Recalls, Reports and Warnings
Over several years, Medtronic has faced a lot of controversy for its INFUSE Bone Graft. It was in 2011 when Dr. Eugene J. Carragee, along with his colleagues published an editorial in The Spine Journal.
The article revealed that several Medtronic-sponsored studies failed to divulge information on possible side effects associated with rhBMP-2. It further showed that the researchers involved with the sponsored studies received $1 million to $23 million per year for royalties and consulting fees.
A journal news release via Health News Review stated:
“The comprehensive review [published in The Spine Journal] found four main areas of concern among the 13 original industry-sponsored studies:
- “Conflicts of interest were either not reported or were unclear in each study.
- “Study design appeared biased against common alternatives for spinal fusion, which could inflate the apparent benefit of the products.
- “The studies included invalid claims about the risks and complications associated with using the patients’ own bone to assist fusion.
- “In the larger trials, common and serious potential complications associated with the industry products were not reported.”
However, prior to the publishing of Dr. Carragee’s article, Medtronic was already under investigation by the United States Department of Justice. In a civil lawsuit, the DOJ claimed that the company was paying kickbacks to doctors in order for them to make use of their own product, as well as other spinal products between 1998 and 2003.
The device manufacturer reportedly set up fake consulting and royalty agreements, in addition to paying for “lavish trips to desirable locations.” It was in 2006 when Medtronic paid $40 million to settle the civil lawsuit.
In July 2008, the FDA issued a Public Health Notification to healthcare providers, warning them of the life-threatening complications that can arise from off-label usage of the medical device in cervical or upper back spinal fusion.
These complications include swelling of the neck and throat tissue that led to difficulty in breathing, swallowing, or speaking. Patients who experienced such adverse events required respiratory support with intubation, medication or a tracheotomy – a surgical procedure where small incisions are made in the neck in order for a tube to be inserted in the opening to aid in breathing.
By the time April 30, 2011 came, the FDA had already obtained hundreds of reports regarding adverse side effects related to INFUSE Bone Grafts. These included severe back pain, leg pain, difficulty breathing, and implant failure.
Several of these complications resulted in successive surgeries for patients in order to correct the complications the medical device had caused. While the FDA originally approved the use of this bone graft for lower back use and only with ALIF surgery, a number of studies released by doctors sponsored by Medtronic promoted “off-label” or unapproved (by the FDA) uses of the device.
According to the studies, using the medical devices to treat complications, which were not approved by the FDA showed good results with little to no side effects. These sponsored studies used the product for off-label procedures such as upper back spinal fusion surgery, jaw reconstruction, and posterior lumbar interbody fusion (PILF) surgery – a surgical technique that gives access to the spine through the back.
In June 2011, the United States Senate launched an investigation into the allegations that the journal entries written by the doctors paid by Medtronic failed to disclose the dangerous and life-threatening side effects of the bone graft.
The Senate is also considering legislation, called “Physician Payment Sunshine Act,” which forces drug and medical device companies to make all doctor payments public.
In October 2012, the Senate Finance Committee announced the results of its year-long investigation into the company’s alleged kickbacks and false advertising: Medtronic had paid study authors over $200 million in consulting fees.
In January 2015, the FDA issued warning letters for the use of bone graft substitutes in patients under the age of 18. The warning stated that these products, including that of Medtronic’s, were only approved for use in patients who are at least 18 years old.
The agency stated that while these products were not approved for use in minors, physicians continue to use them on an off-label basis for younger patients. The FDA has received reports of fluid accumulation, excess bone growth, swelling, and inhibited bone healing, among many others in minors.
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