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The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction.
The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. [3] Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years.
Purported symptoms of metallosis generally include pain around the site of the implant, pseudotumors (a mass of inflamed cells that resembles a tumor but is actually collected fluids), and a noticeable rash that indicates necrosis. [1] The damaged and inflamed tissue can also contribute to loosening the implant or medical device.
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
The FCC created the Medical Implant Communication Service (MICS) in 1999 "in response to a petition for rule making by [Medtronic, Inc.] to permit use of a mobile radio device, implanted in a patient, for transmitting data in support of the diagnostic and/or therapeutic functions associated with an implanted medical device."
Total hip replacement is most commonly used to treat joint failure caused by osteoarthritis.Other indications include rheumatoid arthritis, avascular necrosis, traumatic arthritis, protrusio acetabuli, [5] certain hip fractures, benign and malignant bone tumors, [6] arthritis associated with Paget's disease, [7] ankylosing spondylitis [8] and juvenile rheumatoid arthritis. [9]
Title: 2004-03-25 Jones Federal Complaint.pdf Created Date: 9/17/2015 9:17:23 PM
Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa. [4] A dental implant is considered to be a failure if it is lost, mobile or shows peri-implant (around the implant) bone loss of greater than 1.0 mm in the first year and greater than 0.2 mm a year after. [5]