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Active Surveillance of Medical-Device Safety

Registry-Based Prospective, Active Surveillance of Medical-Device Safety Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first …

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Biphosphonates affect Dental Implants

Influence of Bisphosphonates on Implant Failure Rates and Characteristics of Postmenopausal Woman Mandibular Jawbone Yayima et al. The results indicate that BPs affect the quality and quantity of the cortical bone in the partially edentulous posterior mandible of patients with osteoporosis, which should be considered prior to treatment with dental implants in patients taking BPs. …

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Breast Implants: Update – Associated Anaplastic Large Cell Lymphoma

Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) FDA FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest …

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Claims for faulty breast implants against French insurance fails in Germany

Pain and suffering claims for faulty breast implants against French insurance fails in Germany. Mitteilung A court in Hamm/Germany ruled in a decision published yesterday, that the liability insurer of a meanwhile broke French manufacturer not must be liable for damage caused by the faulty breast implants, if the operation in Germany took place (AZ. …

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Endoprosthesis Register (Germany) shows reasons for early replacements

Acute replacement of hip joint is followed by twice as much second replacement surgery as at standard scheduled surgery. 78.4% of hip endoprosthesis were placed without cementum. Accompanying illness like depression, overweight and diabetes influence the result. Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie The German Endprosthesis-Register (EPDR) lists for 5 years on a voluntary …

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Hacking risk leads to recall of 500,000 pacemakers

Hacking risk leads to recall of 500,000 pacemakers due to patient death fears the guardian FDA overseeing crucial firmware update in US to patch security holes and prevent hijacking of pacemakers implanted in half a million people. Almost half a million pacemakers have been recalled by the US Food and Drug Administration (FDA) due to …

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Long-Term Cancer Risk Among Swedish Women With Cosmetic Breast Implants: An Update of a Nationwide Study

Epidemiologic evidence does not support a consistently increased cancer risk among women with cosmetic breast implants, but few studies have assessed risk beyond 15 years. McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nytren O Swedish women who underwent cosmetic breast implantation for the first time between January 1, 1965, and December 31, …

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Mesh versus suture repair of umbilical hernia in adults

Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial Kaufmann R et al. Findings Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5–33·4). After a maximum follow-up of …

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More complications in heart valve surgery in the morning

Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbα antagonism: a single-centre propensity-matched cohort study and a randomised study Montaigne D et al. Perioperative myocardial injury is transcriptionally orchestrated by the circadian clock in patients undergoing aortic valve replacement, and Rev-Erbα antagonism seems to be a pharmacological strategy for cardioprotection. …

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More than 14.000 cases reported as problems with implants in Germany 2017

  The number of the suspicion reports has tripled within the last ten years. Among other reasons these numbers can be explained with more frequently reports of doctors to the authorities and more frequent use of these products. It´s more critical with the group of the medical products with a high risk for the patient. …

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Patient Dissatisfaction Following Total Knee Arthroplasty

Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature R Gunaratne et al. Dissatisfaction following total knee arthroplasty (TKA) is common. Approximately 20% of patients report dissatisfaction following primary TKA. This systematic literature review explores key factors affecting patient dissatisfaction following TKA.   This review found that patient dissatisfaction pertains to several …

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Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature

Dissatisfaction following total knee arthroplasty (TKA) is common. Approximately 20% of patients report dissatisfaction following primary TKA. R Gunaratne, DN Pratt, J Banda, DP Fick, RJK Khan, BW Robertson This review found that patient dissatisfaction pertains to several key factors. Patient expectations prior to surgery, the degree of improvement in knee function, and pain relief …

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Patients of faulty hip implants can seek damages

India: All patients of DePuy ASR™´s (Johnson and Johnson) faulty hip implants can seek damages Teena Tacker New Delhi: Anyone suffering from faulty hip implants by pharma giant Johnson and Johnson Pvt. Ltd (J&J) can apply for compensation, and not just those who have undergone revision surgery, the chairman of the central expert committee on …

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Vaginal mesh implants, Problems, Class action

Vaginal mesh implants: Class action against Johnson and Johnson begins in Federal Court Sophie Scott, Alison Branley A class action involving more than 700 women has begun, with legal representatives for the women claiming the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh. ABC News Jul 04, 2017

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