Medtronic Infuse Bone Graft Side Effects Lawsuits
Medtronic Infuse Bone Graft Side Effects | Medtronic Cervical Infuse Lawsuits | Medtronic Lumber Infuse Attorney | Texas Medtronic Infuse Bone Graft Injury | Dallas Medtronic Infuse Attorney | Medtronic Infuse Bone Graft Injury Lawyer | Medtronic Infuse Side Effects | Infuse Bone Graft Lawsuits | Infuse Neck Swelling | Infuse Airway Compression
Infuse is a bioengineered material (rhBMP-2), recombinant human bone morphogenetic protein-2, that spurs bone growth. The Infuse bone graft consists of bioengineered liquid bone protein housed in a small container or cage that is implanted into the spine. It is often used in spinal fusion operations, a procedure in which spinal vertebrae are fused together to reduce back pain. Infuse is manufactured by Medtronic, the nation’s largest maker of medical devices. Each year over 100,000 U.S. patients undergoing spinal fusion surgery receive Infuse.
Dr Shezad Malik Law Firm is a leading Defective Medical Device Product Liability law firm and is here to help you receive the best compensation for your injuries. If you or a family member have been injured by an off-label use of the Infuse(R) bone graft procedure, you may have valuable legal rights. For a free evaluation of your case, please visit our website, or CALL TOLL FREE (1-888-210-9693) today.
Dr Shezad Malik Law Firm is actively investigating complaints involving off-label use of Medtronic Infuse(R) bone graft. Dr Shezad Malik is offering free consultations to victims and their families who allegedly have suffered from complications due to the "off-label" use of a Infuse(R) Bone Graft.
Scope of the Problem
In 2002, the FDA approved Infuse for only one specific type of spine surgery – anterior approach lumbar fusion. Infuse was not approved by FDA for (and still is not approved for) use in either lateral or posterior approach lumbar fusion surgeries.
Infuse has never been approved by FDA for use in the cervical spine. Many patients have received Infuse in risky off-label uses in either the lumbar or cervical spine.
When any drug or medical device, such as Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use. The risks of the off-label use must be fully disclosed prior to the surgery, so the patient may make an informed decision as to whether or not he or she wishes to receive the Infuse bone graft.
Some patients who have had Infuse placed in their spine in non-FDA approved surgeries have experienced ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis); sterility, retrograde ejaculation, or other uro-genital injuries in male patients; nerve injuries causing severe and chronic pain; and in cervical spine surgeries: acute severe neck swelling several days after surgery resulting in death or permanent injury.
Medical Studies Reported Adverse Events
On June 28, 2011, The Spine Journal, criticized research by Medtronic-funded physicians encouraging the widespread off-label use of Infuse as “biased and corrupted research.” The articles in The Spine Journal charge that the prior studies in support of Infuse were authored by researchers with significant financial ties to Medtronic, and that this prior research vastly understated or failed to disclose Infuse’s side effects and risks.
Specifically, it was reported that in none of the 13 trials involving 780 patients funded by Medtronic any adverse events from the product were disclosed. Data provided to U.S. regulators and other publications, showed that up to 50 percent of patients suffered side effects, including infection, pain, cyst formation and cancer, and infertility in men, the reviewers said.
Legal Resources for Injured Infuse Patients
The Dr Shezad Malik Law Firm represents patients across America who have been seriously injured by faulty medical devices and products, and the families of loved ones who died from dangerous or defective drugs and devices.
Disclaimer Trademark Notice
Infuse is a registered trademark of Medtronic, Inc. The uses of this trademark is for product identification and informational purposes only. The Dr Shezad Malik Law Firm is in no way affiliated with Medtronic or its subsidiaries.
Infuse Bone Growth Problems Summary: Medtronic Infuse Bone Problem
Many patients who have received off-label use of Infuse in their spine were not informed of the off-label nature of the surgery, and/or were not told of the potential risks of serious and permanent injuries related to such experimental use of this product.
In lawsuits filed against Medtronic, patients have alleged that they were injured and Medtronic failed to disclose serious and potentially life-threatening side effects with Infuse. We represented the family of a patient that received Infuse and died from complications allegedly caused by Infuse. We obtained a confidential settlement for the family.
Specific Injuries Being Investigated
Sterility is just the latest complication associated with Infuse, which already has a warning about the risk of male sterility on the label. The BMP has also been associated with serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.
A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery. This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.
Our law firm’s principal office is in Southlake and we have offices in Fort Worth and in Dallas, Texas. Dr Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide, including | Alabama | Alaska | Arizona | Arkansas | California | Colorado | Connecticut | Delaware | Florida | Georgia | Hawaii | Idaho | Illinois | Indiana | Iowa | Kansas | Kentucky | Louisiana | Maine | Maryland | Massachusetts | Michigan | Minnesota | Mississippi | Missouri | Montana | Nebraska | Nevada | New Hampshire | New Jersey | New Mexico | New York | North Carolina | North Dakota | Ohio | Oklahoma | Oregon | Pennsylvania | Rhode Island | South Carolina | South Dakota | Tennessee | Texas | Utah | Vermont | Virginia | Washington | West Virginia | Wisconsin | Wyoming
We also serve the cities of | New York | Los Angeles | Chicago | Houston | Phoenix | Philadelphia | San Antonio | San Diego | Dallas | San Jose City | Detroit | Jacksonville | Indianapolis | San Francisco | Columbus | Austin | Memphis | Fort Worth | Baltimore | Charlotte | Boston | Seattle | Washington | Milwaukee | Denver | Louisville | Las Vegas | Nashville | Oklahoma City | Portland | Tucson | Albuquerque | Atlanta | Long Beach | Fresno | Sacramento | Mesa | Kansas City | Cleveland | Virginia Beach | Omaha | Miam | Oakland | Tulsa | Honolulu | Minneapolis | Colorado Springs | Arlington | Wichita
Information and Commentary provided by Dallas Fort Worth Personal Injury Attorney Dr Shezad Malik. The Dr Shezad Malik Law Firm can be contacted in Dallas toll free at 888-210-9693 or in Fort Worth at 817-900-8439. If you or a loved one has been injured from a Medtronic Infuse Device, please fill out our contact card for a free consultation.
Infuse is a bioengineered material (rhBMP-2), recombinant human bone morphogenetic protein-2, that spurs bone growth. The Infuse bone graft consists of bioengineered liquid bone protein housed in a small container or cage that is implanted into the spine. It is often used in spinal fusion operations, a procedure in which spinal vertebrae are fused together to reduce back pain. Infuse is manufactured by Medtronic, the nation’s largest maker of medical devices. Each year over 100,000 U.S. patients undergoing spinal fusion surgery receive Infuse.
Dr Shezad Malik Law Firm is a leading Defective Medical Device Product Liability law firm and is here to help you receive the best compensation for your injuries. If you or a family member have been injured by an off-label use of the Infuse(R) bone graft procedure, you may have valuable legal rights. For a free evaluation of your case, please visit our website, or CALL TOLL FREE (1-888-210-9693) today.
Dr Shezad Malik Law Firm is actively investigating complaints involving off-label use of Medtronic Infuse(R) bone graft. Dr Shezad Malik is offering free consultations to victims and their families who allegedly have suffered from complications due to the "off-label" use of a Infuse(R) Bone Graft.
Scope of the Problem
In 2002, the FDA approved Infuse for only one specific type of spine surgery – anterior approach lumbar fusion. Infuse was not approved by FDA for (and still is not approved for) use in either lateral or posterior approach lumbar fusion surgeries.
Infuse has never been approved by FDA for use in the cervical spine. Many patients have received Infuse in risky off-label uses in either the lumbar or cervical spine.
When any drug or medical device, such as Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use. The risks of the off-label use must be fully disclosed prior to the surgery, so the patient may make an informed decision as to whether or not he or she wishes to receive the Infuse bone graft.
Some patients who have had Infuse placed in their spine in non-FDA approved surgeries have experienced ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis); sterility, retrograde ejaculation, or other uro-genital injuries in male patients; nerve injuries causing severe and chronic pain; and in cervical spine surgeries: acute severe neck swelling several days after surgery resulting in death or permanent injury.
Medical Studies Reported Adverse Events
On June 28, 2011, The Spine Journal, criticized research by Medtronic-funded physicians encouraging the widespread off-label use of Infuse as “biased and corrupted research.” The articles in The Spine Journal charge that the prior studies in support of Infuse were authored by researchers with significant financial ties to Medtronic, and that this prior research vastly understated or failed to disclose Infuse’s side effects and risks.
Specifically, it was reported that in none of the 13 trials involving 780 patients funded by Medtronic any adverse events from the product were disclosed. Data provided to U.S. regulators and other publications, showed that up to 50 percent of patients suffered side effects, including infection, pain, cyst formation and cancer, and infertility in men, the reviewers said.
Legal Resources for Injured Infuse Patients
The Dr Shezad Malik Law Firm represents patients across America who have been seriously injured by faulty medical devices and products, and the families of loved ones who died from dangerous or defective drugs and devices.
Disclaimer Trademark Notice
Infuse is a registered trademark of Medtronic, Inc. The uses of this trademark is for product identification and informational purposes only. The Dr Shezad Malik Law Firm is in no way affiliated with Medtronic or its subsidiaries.
Infuse Bone Growth Problems Summary: Medtronic Infuse Bone Problem
Many patients who have received off-label use of Infuse in their spine were not informed of the off-label nature of the surgery, and/or were not told of the potential risks of serious and permanent injuries related to such experimental use of this product.
In lawsuits filed against Medtronic, patients have alleged that they were injured and Medtronic failed to disclose serious and potentially life-threatening side effects with Infuse. We represented the family of a patient that received Infuse and died from complications allegedly caused by Infuse. We obtained a confidential settlement for the family.
Specific Injuries Being Investigated
- ongoing or chronic radiating pain in the legs or arms (i.e., radiculopathy or radiculitis);
- sterility, retrograde ejaculation, or other urogenital injuries in male patients;
- ectopic bone growth or uncontrolled bone growth in the spinal canal;
- nerve injuries causing chronic pain; and
- in cervical spine surgeries: acute severe neck swelling several days after surgery resulting in death or permanent injury.
Sterility is just the latest complication associated with Infuse, which already has a warning about the risk of male sterility on the label. The BMP has also been associated with serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.
A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery. This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.
Our law firm’s principal office is in Southlake and we have offices in Fort Worth and in Dallas, Texas. Dr Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide, including | Alabama | Alaska | Arizona | Arkansas | California | Colorado | Connecticut | Delaware | Florida | Georgia | Hawaii | Idaho | Illinois | Indiana | Iowa | Kansas | Kentucky | Louisiana | Maine | Maryland | Massachusetts | Michigan | Minnesota | Mississippi | Missouri | Montana | Nebraska | Nevada | New Hampshire | New Jersey | New Mexico | New York | North Carolina | North Dakota | Ohio | Oklahoma | Oregon | Pennsylvania | Rhode Island | South Carolina | South Dakota | Tennessee | Texas | Utah | Vermont | Virginia | Washington | West Virginia | Wisconsin | Wyoming
We also serve the cities of | New York | Los Angeles | Chicago | Houston | Phoenix | Philadelphia | San Antonio | San Diego | Dallas | San Jose City | Detroit | Jacksonville | Indianapolis | San Francisco | Columbus | Austin | Memphis | Fort Worth | Baltimore | Charlotte | Boston | Seattle | Washington | Milwaukee | Denver | Louisville | Las Vegas | Nashville | Oklahoma City | Portland | Tucson | Albuquerque | Atlanta | Long Beach | Fresno | Sacramento | Mesa | Kansas City | Cleveland | Virginia Beach | Omaha | Miam | Oakland | Tulsa | Honolulu | Minneapolis | Colorado Springs | Arlington | Wichita
Information and Commentary provided by Dallas Fort Worth Personal Injury Attorney Dr Shezad Malik. The Dr Shezad Malik Law Firm can be contacted in Dallas toll free at 888-210-9693 or in Fort Worth at 817-900-8439. If you or a loved one has been injured from a Medtronic Infuse Device, please fill out our contact card for a free consultation.