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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.
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]
On February 10, 2011, the U.S. FDA issued an advisory on metal-on-metal hip implants, stating it was continuing to gather and review all available information about metal-on-metal hip systems. [67] On June 27–28, 2012, an advisory panel met to decide whether to impose new standards, taking into account findings of the study in The Lancet.
Orthopedic implant example seen with X-ray. An orthopedic implant is a medical device manufactured to replace a missing joint or bone, or to support a damaged bone. [1] The medical implant is mainly fabricated using stainless steel and titanium alloys for strength and the plastic coating that is done on it acts as an artificial cartilage. [2]
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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 ...
Cochlear is a medical device company that designs, manufactures, and supplies the Nucleus cochlear implant, the Hybrid electro-acoustic implant and the Baha bone conduction implant. [ 3 ] Based in Sydney , Cochlear was formed in 1981 as a subsidiary of Nucleus with finance from the Australian government to commercialise the implants pioneered ...