A medical device that has been successful in the past in helping back surgery patients recover has been recalled. The risk of Biomet spinal fusion stimulator side effects has grown and as a result, the FDA has acted.

Recently, the U.S. Food and Drug Administration, FDA, announced a Class I recall for the Biomet spinal fusion stimulator. A Class I recall is reserved for medical devices and products that can be fatal or cause serious injury.

What is a Biomet Spinal Fusion Stimulator?

A spinal fusion stimulator is a medical device that aids in bone regrowth. They are a supplemental form of therapy that has become valuable to both doctors and patients in the recovery from spinal fusion surgery.

Spinal fusion surgery is performed when movement causes severe pain and there are no other options available to the patient. Because bone is a living tissue like skin and muscle, it will grow together if given the proper environment and stimulation.

Bone fragments are placed between the segments of the spine the surgeon wishes to fuse. When surgery is over, osteogenesis begins. Osteogenesis is the process of the body growing back bony tissue.

Osteogeneis occurs over several months. A spinal fusion stimulator aids this process and enhances the body’s healing process.

According to spine-health.com, a spinal fusion stimulator is a small medical device that is placed underneath the patient’s skin and is intended to be in place for six to twelve months. It provides electrical stimulation to the fusion area to help the body grow bone tissue quicker.

Some patients who may be more apt to needing a spinal fusion stimulator include those patients who have had a previously failed spinal fusion or who are having a multi-level spinal fusion. Additionally, patients who suffer from osteoporosis, vascular disease, obesity, diabetes, renal disease and alcoholism may be at a greater risk for needing a spinal fusion stimulator.

However, Zimmer Biomet discovered during routine testing procedures that some of its devices could be exposing patients to potentially toxic chemicals, putting them at risk for dangerous Biomet spinal fusion stimulator side effects. The FDA reports that the Biomet spinal fusion stimulator has “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs.”

These harmful chemicals may cause a toxicity that occurs in tissues and organs called cytotoxicity. Biomet spinal fusion stimulator side effects may also include chronic infections, additional surgeries, paralysis and even death.

Because of the risk of Biomet spinal fusion stimulator side effects, the recall was issued in April 2017 and specifically applies to the SpF PLUS-Mini and SpF XL LLb Implantable Spinal Fusion Stimulators. These devices are used during spinal surgery to provide constant electrical stimulation to the surgical site.

If you or someone you love underwent back surgery with a Biomet spinal fusion stimulator implantation, you may benefit from speaking with an attorney experienced in these Biomet spinal fusion stimulator side effects.