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FDA approves Stryker Howmedica�s antibiotic bone cement
Simplex P with Tobramycin intended for patients undergoing a stage two revision after an infection.
The Food and Drug Administration has granted 510(k) approval to Stryker Howmedica Osteonics to begin marketing a first-of-its-kind bone cement containing the broad-spectrum antibiotic Tobramycin.
Simplex P with Tobramycin fills a niche in joint reconstruction surgery, allowing surgeons to revise failed, infected arthroplasties while giving the added protection of on-site antibiotic prophylaxis. It is manufactured by adding 1 g of Tobramycin to Simplex P acrylic bone cement.
Risk of infection
According to Paul M. Pellicci, MD, of the Hospital for Special Surgery in New York City, patients at a high risk for infection stand to benefit most from the new cement.
�Patients who have a past infection, who need a two-stage revision and reimplantation [are the best candidates],� he said in a telephone interview with Orthopedics Today.
Pellicci also listed patients with diabetes and rheumatoid arthritis as well as those on corticosteroids or with compromised immune systems as viable candidates.
�You can make the argument for using it even in primary replacements, but the risk of infection is so low that it�s not really worth it,� he said.
For years surgeons have been making their own antibiotic bone cement off-label in the operating rooms, mixing regular bone cement with powdered antibiotics such as gentamicin and vancomycin. But this process can result in a nonuniform mixture with diminished adhesive qualities, which can lead to failure of the joint.
�The powder doesn�t mix well, but with the Tobramycin cement these issues have become nonissues,� Pellicci said.
Simplex P with Tobramycin is physically indistinguishable from regular Simplex P, according to Pellicci, who estimated that he has used the new cement in about a dozen patients.
Nephrotoxicity is a contraindication, according to Pellicci. Although blood serum levels of Tobramycin remain low, surgeons should think twice before using Simplex P with Tobramycin on patients with altered renal function.
The list price on Simplex P is $104; the list price on Simplex with Tobramycin is $475.
The FDA approved Simplex P with Tobramycin as a Class II medical device.