Implant failure: Difference between revisions

In 2013 [[Johnson & Johnson]] shared documents which indicated that 40% of a class of hip replacement implants which it manufactured had failed.<ref>{{cite news |url= https://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0 |title=Maker Aware of 40% Failure in Hip Implant - NYTimes.com |first=Barry |last=Meier |work=[[The New York Times]] |date=22 January 2013 |location=[[New York, NY|New York]] |issn=0362-4331 |access-date=5 June 2013}}</ref>

Cochlear implants are used to treat severe to profound hearing loss by electrically stimulating the hearing nerve. Clinical symptoms of cochlear implant failure include auditory symptoms (tinnitus, buzzing, roaring, popping sounds), non-auditory symptoms (pain, shocking sensation, burning sensation, facial stimulation, itching), and decrease in the patient's hearing performance.<ref>{{cite journal |pmid=16015190 | volume=26 | title=Cochlear implant soft failures consensus development conference statement | year=2005 | journal=Otol. Neurotol. | pages=815–8 |author1=Balkany TJ |author2=Hodges AV |author3=Buchman CA |author4=Luxford WM |author5=Pillsbury CH |author6=Roland PS |author7=Shallop JK |author8=Backous DD |author9=Franz D |author10=Graham JM |author11=Hirsch B |author12=Luntz M |author13=Niparko JK |author13-link=John Niparko |author14=Patrick J|author15=Payne SL |author16=Telischi FF |author17=Tobey EA |author18=Truy E |author19=Staller S | issue=4 | doi=10.1097/01.mao.0000178150.44505.52 | s2cid=23950969 }}</ref> When such symptoms occur, the patient's clinical team evaluates the patient and the device using in-situ methods, and determines if revision surgery is necessary. The most commonly reported device failures are due to impacts, loss of hermeticity, and electrode lead malfunctions. Most manufacturers provide on their websites the survival rate of their marketed implants, although they are not required to do so. In order to improve and standardize failure reporting practices to the public, the AAMI is developing an American standard for cochlear implants in collaboration with the FDA, major cochlear implant manufacturers, the [[Center for Advanced Life Cycle Engineering|CALCE]] center for reliability, doctors, and clinicians.<ref>{{cite web |url=https://standards.aami.org/kws/public/workgroup?wg_abbrev=CI |title=Association for the Advancement of Medical Instrumentation : CI - Cochlear Implants Committee |website=standards.aami.org |url-status=dead |archive-url=https://web.archive.org/web/20140712060508/https://standards.aami.org/kws/public/workgroup?wg_abbrev=CI |archive-date=2014-07-12}}</ref>

Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa.{{citation needed|date=June 2013}}<ref>{{Cite journal|first1=Girish|last1=Galagali|first2=E. Srinivas|last2=Reddy|first3=Prakash|last3=Nidawani|first4=Sidhartha|last4=S P Behera|first5=Pavan|last5=Preetham|first6=Mythri|last6=Sarpangala|date=January–March 2014|title=Implant Failures: A Comprehensive Review|url=http://ijpcdr.com/pdf/2014/January-March/9044.pdf|journal=International Journal of Preventive & Clinical Dental Research|volume=2014;1(1)|pages=11–17}}</ref>
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&nbsp;mm in the first year and greater than 0.2&nbsp;mm a year after.<ref>Tissue-integrated prostheses :osseointegration in clinical dentistry, Per-Ingavar Branemark, George A. Zarb, Tomas Albrektsson, 1985</ref>

Dental implant failures have been studied.<ref>{{Cite journal | last1 = Moy | first1 = P. K. | last2 = Medina | first2 = D. | last3 = Shetty | first3 = V. | last4 = Aghaloo | first4 = T. L. | title = Dental implant failure rates and associated risk factors | journal = The International Journal of Oral & Maxillofacial Implants | volume = 20 | issue = 4 | pages = 569–577 | year = 2005 | pmid = 16161741}}</ref> Persons who [[Smoking|smoke]] habitually prior to having dental implants are significantly more likely to have their implants fail.<ref>{{Cite journal | last1 = De Bruyn | first1 = H. | last2 = Collaert | first2 = B. | doi = 10.1034/j.1600-0501.1994.050410.x | title = The effect of smoking on early implant failure | journal = Clinical Oral Implants Research | volume = 5 | issue = 4 | pages = 260–264 | year = 1994 | pmid = 7640341}}</ref> Individuals who suffer fromhave diabetes and those who disregard general oral hygiene are also at higher risk of having their implants fail.

In 2012 [[Royal College of Surgeons of England]] and the [[British Orthopaedic Association]] called for increased regulation of implants to prevent implant failure.<ref>{{cite news |url= https://www.telegraph.co.uk/health/healthnews/9631974/Faulty-medical-implants-investigation-Patients-failed-by-poor-implant-regulation-say-surgeons.html |archive-url= https://web.archive.org/web/20121025092558/http://www.telegraph.co.uk/health/healthnews/9631974/Faulty-medical-implants-investigation-Patients-failed-by-poor-implant-regulation-say-surgeons.html |url-status= dead |archive-date= 25 October 2012 |title=Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons - Telegraph |first1=Holly |last1=Watt |first2=Claire |last2=Newell |work=[[The Daily Telegraph]] |date=24 Oct 2012 |location=[[London, UK|London]] |issn=0307-1235 |oclc=49632006 |access-date=5 June 2013}}</ref>

A 2011 study by Dr. [[Diana Zuckerman]] and Paul Brown of the [[National Research Center for Women and Families]], and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious"serious health problems or death”death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues.<ref>{{cite journal|last=Zuckerman|first=Diana|title=Medical Device Recalls and the FDA Approval Process|journal=Archives of Internal Medicine|year=2011|url=http://archinte.jamanetwork.com/article.aspx?articleid=227466|doi=10.1001/archinternmed.2011.30|pmid=21321283|volume=171|issue=11|pages=1006–11|doi-access=free}}</ref> This may lead to a reevaluation of FDA procedures and better oversight.