FDA: Clinicians should avoid use of some bone graft substitutes in young patients

PRLog – Jan. 28, 2015 – CALABASAS, Calif. — The Federal Drug Administration has issued a new warning on graft substitutes containing recombinant proteins or synthetic peptides.

The agency said these products should not be the first treatment considered for patients under age 18 with significant bone defects or rare bone disorders.

The FDA has not approved these products for use in patients under age 18 because their bones may still be growing. The agency said using this product may cause serious injuries and recommends that health care providers consider other treatment options first.

Bone grafting is a surgical procedure used by dentists to replace missing bone or repair bone defects.

Calabasas Dental Institute’s Dr. Greg Rubin, who has more than 30 years experience in the dental field, agrees. He says younger patients require different procedures because their jaw bone is still forming.

“In older patients, when you lose a tooth, you lose bone,” Dr. Greg Rubin said.

“When that happens, an implant is the only solution in most cases. But in younger patients, whose teeth are still forming, there are other creative, much less invasive techniques we can employ that are not only affordable, but also offer much more desirable results.”

The FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern.

“Any product that affects bone growth could have the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates,” the FDA said on its website.

The FDA recommends against routine use of these products in patients under age 18 because their safety and effectiveness has not been reviewed or approved for use in this population.

The Calabasas Dental Institute is located at 4764 Park Granada #107, Calabasas, CA 91302; (818) 224-2420.

Using the latest in high-tech digital technology, this group of dental experts and specialists provide first rate personalized service in all aspects of cutting edge general and cosmetic dentistry. A sleep apnea treatment center, which offers the most advanced oral treatments on the market, is also conveniently located on the premises. Doctors at the Calabasas Dental Institute, which is the first dental office in Southern California to accept Bitcoin as payment, have pioneered some of the leading technologies in the treatment of bad breath and operate a one-stop bad breath treatment facility at the Calabasas location. For their innovation, they have been recognized nationally as leading experts in bad breath treatment by HealthTap.com, which ranked the group #1 among other health experts in the field. For more information, please visit CalabasasDentalInstitute.com.