Karina Basso  |  February 11, 2015

Category: Legal News

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

doctor checks child back with stethoscopeOn Jan. 21, the FDA issued a notice, warning doctors and parents of children with bone growth defects of the dangers of using bone grafts, like Medtronic’s Infuse Bone Graft, in individuals under the age of 18.

According to the FDA bone graft warning, there are multiple problems and side effects that occur in children who received a bone graft treatment that do not become apparent until they reach adulthood.

Bone grafting is considered a technical, major medical procedure that is regularly performed by pediatricians, dentists, orthopedic surgeons, neurosurgeons, and plastic surgeons to treat various types of physical conditions. As a medical process, bone grafting involves stimulating or implanting bone in areas of the body where it is needed or deficient.

The Infuse Bone Graft System—designed, manufactured, and sold by Medtronic Inc.—works similarly to other, more traditional, bone graft products and procedures, though it has become more popular because it is less invasive than other forms of bone graft surgery.

Infuse is essentially a synthetic protein that is mixed with bovine collagen, then injected into a patient’s body, in the surgical area that needs bone graft material. Once injected, the Infuse Bone Graft facilitates and encourages bone growth in affected joints and bones.

The process by which the Infuse bone graft product works is known as “osteoconductive stimulation,” a procedure which is currently under investigation and review by the FDA. While traditional bone grafts work by implanting healthy bone tissue from other areas in the body, Infuse and other products works through osteoconductive stimulations, where a synthetic, man-made material is implanted as a “scaffold” into the affected area. This scaffold would then ideally encourage the “migration” of healthy bone cells to the surgical area, which would then create new bone tissue.

The scaffolds, like the one employed by the Infuse bone graft system, contains peptides and synthetic proteins that can mimic bone growth, a feature that has caused the FDA concern, especially when Infuse and other osteoconductive stimulation products are used to stimulate pediatric growth.

FDA Concerns with Infuse and Other Osteoconductive Stimulators

As of Jan. 15, 2015, these type of bone graft products, including the Infuse System, are only approved for “skeletally mature” individuals. Children under the age of 18 are considered “skeletally immature” and as such the use of synthetic bone growth peptides and proteins, like those found in Infuse, are prohibited by the FDA in orthopedic and dental procedures where a bone graft is needed to be implanted in an underage patient.

According to the FDA reports, there have been several documented cases of severe side effects occurring in pediatric patients who were implanted with synthetic bone growth products like Infuse, products that are generally regulated and almost exclusively used in patients suffering from rare, incurable bone growth diseases.

The FDA bone graft warning, some side effects experienced by bone graft pediatric patients include:

  • Excessive bone growth
  • Accumulation of fluid in the bone graft area
  • Inhibited bone healing
  • Swelling

The agency has noted that adult bone graft patients have experienced similar side effects, but that these bone graft complications are more worrisome in pediatric bones because they have not fully formed, making this bone graft side effects potentially more damaging.

Background on Infuse Bone Graft System

Since 2002, over 100,000 patients have been implanted with an Infuse bone graft. The Medtronic  Infuse Bone Graft System has been a popular choice in bone graft surgeries across the nation, especially when surgeons perform spinal fusion procedures.

Despite its popularity, recent FDA and medical reports have demonstrated that there exist many risks with using the Infuse bone graft system.

Some Infuse bone graft side effects reported  for label and off-label use of the Medtronic product include:

  • Infection
  • Male sterility
  • Bone and nerve damage
  • Urinary problems
  • Increased risk of cancer

Patients who allege they experience painful and long-lasting side effects of Infuse after a spinal fusion surgery should consider filing Infuse lawsuits or joined Infuse class action lawsuits.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

Learn More

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Get Help – It’s Free

Join a Free Medtronic Infuse Class Action Lawsuit Investigation

An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

Oops! We could not locate your form.

Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.