When a California company developed a product to be used in spinal fusion surgeries, the firm's president said he knew it faced a new "ethical dilemma," even noting a recent NPR news investigation questioning the high profits some firms were making from donated human tissue.
Spinal Elements, a small and growing company, had long made plates, screws and other technology used in spinal surgeries. But its new Hero Allograft was the first product it ever made from the tissue in this case the bones of a donated human cadaver.
Jason Blain, president of Spinal Elements, says the company struggled with the idea of making a profit off of a product even though the company put in its own research and labor to make it that could not have been made without a family agreeing to donate a loved one's body. "We think that allograft represents the physical embodiment of someone's life and it should be treated that way," says Blain.
He says the product's name, Hero Allograft, honors the families that made the decision to donate a body. And Spinal Elements will donate the net proceeds to two charities, the Make-a-Wish Foundation and St. Jude Children's Research Hospital. Blain says he hopes to donate at least several thousand dollars a month.
The product, which comes in various formats, will cost about $250 to $2000 per graft, Bain says.
The company's announcement cites a series of NPR stories reported with the International Consortium of Investigative Journalists, which showed that the human tissue industry is a little-known and lightly-regulated adjunct to organ donation. But unlike organ donation, it generates big profits at least $1 billion a year on sales in the U.S.
The new product is a bone paste that is made by crushing, cleaning and processing human bone. Paste made from cadaver bone, the company says, can easily meld with a patient's own bone, better stabilizing the spine.
In some ways, the announcement from Spinal Elements reflects clever marketing. The company is entering a market where other, bigger companies already sell similar bone paste. But Blain is counting on surgeons sharing his qualms about the profits made off human tissue donation and wanting to adopt a new approach.