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Infuse Should not be Used in Patients Under age 18, the FDA Warns

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In a Safety Communication issued today, the U.S. Food and Drug Administration (FDA) warned that Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are not safe for use in patients under age 18.

Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are considered high-risk (Class III) medical devices by the FDA. Medtronic and the manufacturers of similar products must submit a premarket approval application (PMA) to the agency that includes clinical data supporting safety and effectiveness, the FDA explained in the Safety Communication. These devices have not been approved for use in people under age 18 and have not been reviewed by federal regulators.

Smaller body size and still growing bones can make Infuse and similar products very dangerous for people under age 18. These products can cause problems with skeletal development by alterning normal bone formation and growth, particularly if it is used near open growth plates,have a negative impact on skeletal development by altering normal bone formation and growth plates, the FDA warned on its website. The FDA said patients have reported serious injuries, including excess bone growth, fluid accumulation, and inhibited bone healing and swelling.

The FDA included a list of recommendations for pediatricians, plastic surgeons, orthopedic surgeons and neurosurgeons to refer to:

-Infuse and other bone graft substitutes should be avoided in patients under age 18 because their safety and efficacy have not been reviewed by the FDA and the products are not approved for use in this population.

-Autograft bone and allograft bone and other products that do not contain recombinant proteins or synthetic peptides should be considered before using Infuse and other bone graft substitutes containing recombinant proteins and synthetic peptides in patients under age 18.

-Consider the benefits and risks of these products before implanting them in any patient. If Infuse or another product is the best option, inform parents/guardians and patients about the risks and benefits of using the product when discussing surgical options.

-Closely monitor patients younger than 18 for adverse events and if necessary, refer them to the appropriate healthcare provider for corrective treatment. Be on the alert for problems with skeletal development, excess growth of other tissues, and tissue swelling or fluid accumulation that could put pressure on neighboring organs or tissues.

breakinglawsuitnews.com disclaimer: This article: Infuse Should not be Used in Patients Under age 18, the FDA Warns was posted on Thursday, January 22nd, 2015 at 6:42 pm at breakinglawsuitnews.com and is filed under Product Liability Lawsuits.

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