Children Receiving Unapproved Products to Speed up Bone Formation

As part of their spine fusion surgery, a significant number of children in the U.S. are getting injections of bone growth proteins, not approved for use in children, to speed up bone formation, says a new study.

Spinal fusion is a surgical procedure adopted to solve problems with the small bones of the spine or vertebrae.

The study, published in the Journal of the American Medical Association, found nearly one in 10 children in the U.S. (9.2 percent) under the age 18 receiving the genetically engineered bone growth stimulating product, known as morphogenetic protein (BMP) as part of their spine fusion surgery.

"BMP is a powerful molecular growth (agent), and its use in kids is concerning," Sohail Mirza, a professor of orthopedics at the Dartmouth Medical School, who was not involved in the study, told JSOnline.

The product manufactured by Medtronic that helps in the growth of new bones instead of taking the patient's bones received approval for use in adults in 2002.

However, the company has been in the middle of a controversy for a long time for not informing the side effects of the product like cancer risk, infections, bone dissolution, back and leg pain and sterility in men.

But, the side effects of the products on children are yet to be fully explored.

"It is expensive, we don't know if it's effective, and we don't know what the long-term implications are," Dr. Emily Dodwell, a surgeon at the Hospital for Special Surgery in New York who led the research, told Reuters.

Apart from that, according to the researchers, there is no adequate proof to support the benefits of using the product on the young generation, where the healing process is much easy and faster compared to older generation.

For the study, Dodwell and colleagues included more than 4,100 hospitals and found a shocking number -771 children out of total 8,289 receiving BMP in 2009.

The researchers, finding complications among 3 percent of children after using BMP and the surgeries much expensive (19 percent) than the normal one without using it, urge health experts to avoid the product until getting proper supporting data.

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