As more negativity surrounds the Medtronic INFUSE bone growth product, the company’s market share and stock value continue to decline.
According to a report from Trefis.com, a stock analysis service, the recent U.S. Senate findings that Medtronic manipulated purportedly scientific data that downplayed the risks of dangerous side effects INFUSE posed to recipients and that some of this data was used to help get the bone growth protein approved for use has caused the company’s market share of spinal fusion products to drop even more than it already has.
Trefis.com reports that in 2008, Medtronic enjoyed a 40 percent share of the spinal division. That figure was buoyed by sales of INFUSE, which is designed to supplant the traditional bone graft as a means of stimulating new bone growth in a spinal fusion surgery. Sales skyrocketed on news of its apparent successes.
But since that time, the market share enjoyed by Medtronic has dropped and has continually declined. That share now stands at just 35 percent and the analysts believe it will likely drop below 30 percent or lower, as long as news surrounding INFUSE continues its negative trend.
Medtronic is already facing increased federal scrutiny and mounting legal pressure from the many recipients of INFUSE in just that short period of time. In addition to manipulating safety data and misleading surgeons and would-be recipients of the product, Medtronic also actively promoted the use of INFUSE for off-label purposes.
INFUSE is only approved in select spinal fusion surgeries but Medtronic was actively marketing its use to surgeons in other surgeries, including those on the neck as it attempted to gain FDA approval. This has resulted in numerous reports of complications that have caused severe and life-threatening injuries. Those adversely affected by INFUSE have suffered excessive bone growth, severe pain and inflammation, some cases of male sterility, and cancer after receiving the bone growth product in their surgery.
Many recipients claim they were never warned of the dangers of INFUSE before it was used in their surgery and as times goes by, they along with federal regulators and company shareholders are learning of the means by which INFUSE reached the market and bolstered the company’s bottom line.
The market share for Medtronic has steadily declined as more details regarding the marketing of INFUSE are learned. Last year, The Spine Journal dedicated an entire edition of the publication detailing how Medtronic manipulated data first-hand by altering findings, or by encouraging the researchers hired to provide clinical data on the product to get it approved by the FDA to omit data on some of the more dangerous side effects of INFUSE.
As more details emerge, Trefis.com believes the market share for Medtronic will continue its downward trend. The rate and severity of the decline will depend on the entirety of the fallout from INFUSE’s early struggles.