The FDA approved surgical meshes for procedures like abdominal surgery. But J&J began marketing them for use in a women’s vaginal area, treating problems like incontinence. Subsequently, hundreds of women became severely injured and some died as the meshes began disintegrating, growing into tissue and becoming impossible to remove.
Meanwhile, the company’s Securities and Exchange Commission filing revealed last Friday that the United States attorney’s office in Massachusetts and the civil division of the Justice Department are investigating J&J's marketing of its its ASR hip replacements. That’s the Frankensteinian device that J&J finally recalled in 2010 even though it apparently knew the device was failing and releasing high levels of metallic ions, and which it is now defending in a bunch of lawsuits. See some of our previous coverage here.
And also last Friday, the U.S. Food and Drug Administration said it has “notified healthcare professionals of a Class I recall, the most serious type,” of J&J’s LPS Diaphyseal Sleeve, used in reconstructive knee surgery. Apparently, says the FDA, this device as the “potential for fractures” and the FDA has already received 10 reports of the device malfunctioning:
A fracture in the sleeve at the joint of it could lead to loss of function or loss of limb, infection, compromised soft tissue or death, the FDA said.
From now on, Johnson & Johnson needs to stick to cotton swabs. The outer ear is as far inside the body we would like J&J products to go, thank you very much.