The Verdict - The Lombardi Law Firm Blog
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If you’ve had a Stryker Custom Cranial Implant surgically implanted to correct lower, upper jaw, face or cranium defects due to injury you’ll need to read the FDA Announcement and contact the surgeon who performed the surgery. You are at risk of infection.
All hospital administrators need to check supply shelves and return the kits.
If any patient needs assistance contact our office. The FDA Alert is below with the necessary link.
Stryker Custom Cranial Implant Kits
Audience: Maxillofacial surgeons, hospital risk managers
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.
Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker
Doctors are only human, and as such are subject to making mistakes. That doesn’t mean the patient or the insurance pays when the mistakes are easily avoidable, those known as “never events”.
Whether it’s a double mastectomy that complicates and killss the patient or the man with his healthy kidney removed, rather than the one with cancer, there is a cure for this type of mistake. It’s called the time-out.
”Out of 4,817 serious problems tracked over the past 12 years by the Joint Commission, the chief accrediting organization for hospitals, 625 were wrong-site surgeries. These are the nightmares: A Long Island, N.Y., woman in her 30s who never had cancer received an unnecessary double mastectomy—then died the following day of complications from the procedure. A man in a Brooklyn, N.Y., hospital had his healthy kidney removed—instead of his cancerous one.”
FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh