NEWS on implant problems

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...

Adverse events of reoperation after elective shoulder replacement

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An enzymatic pathway that converts A to universal O type blood

An enzymatic pathway in the human gut microbiome that converts A to universal O type blood Access to efficient enzymes that can convert A and B type red blood cells to ‘universal’ donor O would greatly increase the supply of blood for transfusions. Here we report the functional metagenomic screening...

Anaplastic large cell lymphoma from breast implants

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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...

Breast implants may falsify EKG (german)

Breast implants may hinder the EKG and show false heart attacks. Bun S-S A tram of cardiologists examined 50 women without heart problems, mean age of 42 years. 28 had beast implants. 57 % of EKG at breast implant patients have been valuated wrong. Deutsches Ärzteblatt 22. Juni 2017

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...

C. R. BARD discontinues selling vaginal mesh products globally

Leading manufacturer exits vaginal mesh market globally Bard halted the use of certain mesh products in the United States in 2012. Since then, Bard has paid out hundreds of millions of dollars in settlements and damages in the U.S. to women who said they were harmed by mesh. The company...

Call-back of pacemakers

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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...

Complications with an implantable insulin pump

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Concerns about paclitaxel-coated stents and balloons removed

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Court orders TÜV to pay damages in breast implant scandal

According to the verdict published the previous day, around 1,600 plaintiff women are to receive provisional compensation of 5,150 euros each, or a total of around 8.2 million euros. Within two years, an expert is to investigate the matter further. TÜV announced that it would appeal against the decision in...

Criminals fake implants with 3-D-tools

Darum gefährden 3-D-Drucker unsere Gesundheit Die Welt, Germany Criminals fake implants, protheses and pacemaker with 3-D-tools Carsten Dierig

Dangerous information deficit on implants (implant files, german)

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Depression, Antidepressants, and Bone Health in Older Adults

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DePuy ASR™ Hip Recall Guide

Informations about problems and recall details. In August 2010, DePuy Orthopaedics issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. Please select your country from the list below to learn more. Find information about possible symptoms, testing, treatment, and DePuy's commitment to...

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...

Europe: Authorities judge cancer danger at breast implants differently

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FDA again warns against Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

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FDA challenged over metal implants ‘public health travesty’

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FDA: Known risk of lymphoma from breast implants

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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...

Heart pacemakers and defibrillators often not affected by electromagnetic fields in everyday life

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implant files

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implant files: what you should know about

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ImplantFiles: Frequently asked questions and resources for readers

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Incidence of New-Onset Atrial Fibrillation After TAVI

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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...

Medical device that treats pain shocks, burns patients

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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)....

Metal corrosion in modular connections between cone adapter (CoCr alloy) and shank (Ti alloy) in hip implant systems (german)

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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...

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...

Nanoparticles activate the NLR pyrin domain containing 3 (Nlrp3) inflammasome and cause pulmonary inflammation

Nanoparticles are increasingly used in various fields, including biomedicine and electronics. One application utilizes the opacifying effect of nano-TiO2, which is frequently used as pigment in cosmetics. Although TiO2 is believed to be biologically inert, an emerging literature reports increased incidence of respiratory diseases in people exposed to TiO2. Thus,...

Overcoming Addiction for the Sensory Impaired

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Pacemaker hack may put malware directly on the device

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Paris court awards compensation to women for faulty breast implants

For years, the now insolvent manufacturer PIP had produced implants that were susceptible to rupture. The testing organization TÜV Rheinland had certified the process. A French court has now granted compensation to the complainants. The Paris Court of Appeal on Thursday condemned the testing organization TÜV Rheinland for lack of...

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 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...

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...

PIP Poly Implant Prosthesis: German supreme court announces decision for 27.02.2020

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Proton Pump Inhibitors and the Risk of Osseointegrated Dental Implant Failure

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Recall of certain breast implants and tissue expanders from market

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Recall of textured Allergan Natrelle BIOCELL and McGhan implants and tissue expanders (2018)

BfArM, FDA: "Based on currently available information, including newly submitted data, our analysis shows that the risk of BIA-ALCL with textured Allergan Biocell implants is approximately six times higher than the risk of BIA-ALCL with textured implants from other manufacturers, and continued distribution of Allergan Biocell textured breast implants would...

Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery

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Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg (Systematic Review/Meta‐Analysis)

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Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems (FDA)

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Serotonin and the Risk of Osseointegrated Implant Failure

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Serotonin Inhibitors and Risk of Dental Implant Failure

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Spinal chord stimulators (implant files)

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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....

Wait time for hip fracture surgery – association

Association Between Wait Time and 30-Day Mortality in Adults Undergoing Hip Fracture Surgery D Pincus et al. Among adults undergoing hip fracture surgery, increased wait time was associated with a greater risk of 30-day mortality and other complications. A wait time of 24 hours may represent a threshold defining higher...

What you should know about “implant files” (german)

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When the breast implant makes sick

In association with breast implants, complications sometimes occur, such as large cell lymphomas and capsular fibrosis. At the annual conference of the German Society for Senology, renowned experts gave advice on how to minimize the risk. In breast reconstruction, the 1-year incidence for capsular fibrosis is about 12% and the...

When the pacemaker is hacked

Cybercrime against healthcare facilities is on the rise, and the networking of medical devices opens up numerous gateways for hackers. To protect patients and facilities, all players must cooperate, and the manufacturers of medical devices have a special role to play. Modern hospitals and other healthcare facilities depend on functioning...