Overview: Medtronic Infuse, a product used in spinal fusion surgeries to stimulate bone growth, can lead to serious, even life threatening side effects, warns the national law firm of Parker Waichman LLP. In a press release issued last week, the nationwide personal injury firm announced that it is offer free legal consultations to patients who have received the device. Infuse has become a controversial product due to safety concerns, and a recent Senate investigation has only fueled these fears.
- Parker Waichman LLP offers free legal advice to patients who have received Medtronic Infuse
- Medtronic Infuse is used to help grow bone in the spine but it has become controversial due to reports that Medtronic paid researchers to hide side effects
- The United States Senate Finance Committee recently investigated Medtronic, and found that the company had employees “ghostwrite” 11 medical journals promoting Infuse
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Medtronic Infuse Side Effects
Medtronic Infuse has been linked to serious side effects, including male sterility, nerve injury, excessive bone growth, difficulty breathing or swallowing, and even cancer. These complications were brought to light last summer, when a group of spine experts collectively researched Infuse and found these side effects. The experts criticized Medtronic-funded researchers for failing to include these complications in their papers.
Infuse seems to have particular safety issues associated with its off-label use, meaning that it is being used in a procedure not approved by the FDA .Currently, it is approved for lower regions of the spine and two types of dental surgery. However, the majority of the time Infuse is used for other off-label uses, such as in the cervical spine. In 2008, the FDA warned that using Infuse in this manner could pose life-threatening complications, including difficulty breathing and swallowing.
Senate Investigation Reveals Suspicious Financial Ties
Recently, the US Senate Finance Committee found that Medtronic had used marketing employees to help edit or “ghostwrite” studies about Infuse. Furthermore, the investigation revealed that the authors of these edited papers were paid millions in royalties and consulting fees, but never disclosed this information to the public. Overall, the report only fuels allegations that Medtronic acted unethically and deceived the public in order to promote Infuse.