Women Possibly At Higher Risk for Medical Device Failures?

“Are women more likely to be harmed by medical device failures?” By: Ben Hallman https://www.icij.org/blog/2018/12/are-women-more-likely-to-be-harmed-by-medical-device-failures/ For the last year, the International Consortium of Investigative Journalists has been investigating the medical device industry around the world. They found that there are very relaxed regulations in the implant industry, which allows dangerous products, like metal on metal […]

Victims & Medical Professionals Not Warned of Product Failures

Article link: https://www.icij.org/investigations/implant-files/hidden-dangers-patients-doctors-not-informed-of-defective-implants/ Article title: Hidden Dangers: patients, doctors not informed of defective implants By Spencer Woodman This article begins with the story of Vijay Vojhala, an Indian man who received a Johnson & Johnson metal-on-metal hip in 2008. Vojhala’s implant was the DePuy Orthopaedics ASR hip system. In 2011, Vojhala went to a medical product […]

European Lobbying Impeded on Safety of Medical Devices

Article Link: https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/ Article Title: How lobbying blocked European safety checks for dangerous medical implants By Simon Bowers In recent years, there have been two major attempts to increase safety regulations for medical implants in the European Union. However, lobbyists have shot down both of these reform attempts by misleading policymakers about their products. Public […]

Victim Hope Fluctuating

Article Link: https://www.icij.org/investigations/implant-files/patient-hopes-rise-and-fall-as-an-industry-balances-progress-and-profit/ Article Title: Patient Hopes Rise and Fall as An Industry Balances Progress and Profit By Dean Starkman and Delphine Reuter The article starts with a description of a 2008 sales meeting for DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. The sales gathering was more of a party than a meeting: […]

Medical Devices Cause Unexpected Issues in Patients

Article link: https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/ Article Title: Medical Devices Harm Patients Worldwide as Governments Fail on Safety By ICIJ This article is the result of an extensive study involving over 250 journalists across 36 countries. The investigation found that, in recent decades, medical implants have caused patients a great deal of harm because governments have approved them […]

Defective Medical Device Victims Speak Out

Article Link: https://www.icij.org/investigations/implant-files/patients-fight-for-answers-as-broken-implants-cause-unseen-agony/ Article title: Patients Fight For Answers as Broken Implants Cause Unseen Agony. By: Spencer Woodman This article highlights the heartbreaking stories of patients around the world who received faulty medical device implants. In doing so, they interviewed Jeong Sang-Ho, a 47-year-old from Seoul, South Korea, who is currently embroiled in a years-long […]

Higher Wear Rates for Biomet Hips than Other MoM Hips

Title: Explant Analysis of the Biomet Magnum/ReCap metal-on-metal hip joint Abstract Metal-on-Metal (MoM) hip resurfacing implants and MoM total hip arthroplasty (THA) implants have recently been questioned by the medical community because of their high revision rates. Understanding the reasons for failure can provide insight into how implants can be improved. Furthermore, looking at the […]

Biomet M2a Magnum Hip is Hard to Revise

Title: Modular to Monoblock: Difficulties of Detaching the M2a-Magnum Head Are Common in Metal on Metal Revisions Where Are We Now? Metal-on-Metal total hip arthroplasty (MoM THA) implants consist of many metal parts that rub together over the course of normal use. The medical community used to think that corrosion — which is essentially rusting […]

Study: Biomet M2a Magnum Heads Greatly Increase Risks

Title: Modular to Monoblock: Difficulties of Detaching the M2a-Magnum Head Are Common in Metal-on-metal Revisions Abstract Metal-on-Metal total hip arthroplasty (MoM THA) implants are made up of a variety of components. One common component is the modular head; it is supposed to be easy to remove during revision surgery. However, it can actually be incredibly […]

Study: Metal Hips Cause Higher Metal Ion Levels than Resurfacing

Title: Higher Blood Cobalt and Chromium Levels in Patients with unilateral metal-on-metal total hip arthroplasties compared to hip resurfacing Abstract High cobalt and chromium levels in the blood are known to cause negative side-effects in patients with metal on metal hip replacements. This study discusses the risk factors and the overall likelihood that that people with […]

~9% Chance of Pseudotumors 5 Years After Biomet Magnum M2a Hip

Title: A 5-year survival analysis of 160 Biomet Magnum M2a metal-on-metal total hip prostheses Abstract Large-head metal-on-metal (MoM) total hip arthroplasties (THA), or hip implants, have high failure rates. This study looks at the conditions of 160 hip devices 5 years after implantation in order to determine their failure rate; all 160 devices were Biomet […]

Monitor for Cobalt Chromium Levels and Pseudotumors Very Early On

Title: Clinical and Wear Analyses of 9 Large Metal-on-Metal Total Hip Prostheses Abstract All patients in this study had the Biomet Magnum (M2a-Magnum™) hip implant with a Recap cup and Taperloc (Taperloc1 Hip Stem) or Mallory stem. This study attempts to figure out the underlying reasons for implant failure by looking at the wear analyses […]

Metal Hips Cause Levels 26x Cobalt Increase and 15x Chromium Increase

Title: The Effect of Different Bearing Surfaces on Metal Ion Levels in Urine Following 28mm Metal-on-Metal and 28mm Metal-on-Polyethylene Total Hip Arthroplasty Abstract Total hip arthroplasty (THA), or hip replacement surgery, is known to increase levels of metal ions in the body. This is because the implant devices can shed metal particles into the body. […]

Metal on Metal Hips Linked to Early Onset Dementia and Depression

Title: “Neuropsychiatric symptoms following metal-on-metal implant failure with cobalt and chromium toxicity” Abstract Many metal-on-metal (MoM) total hip replacement implants have been recalled due to high failure rates. This study assesses the mental health of 10 patients who underwent revision surgery for failed MoM implants. The authors believe this is the first study to find […]

Pseudotumor in a Patient with a Biomet Hip Implant

Research Title: Pseudotumor in Large-Diameter Metal-on-Metal Total Hip Articulation Abstract This case study focuses on a patient who experienced pain in her hip following a large-diameter metal-on-metal (MoM) hip replacement. She also developed a pseudotumor, which is an abnormal swelling of tissue that resembles a tumor. Intro MoM hip implants are thought to be more […]

Vision Loss from Cobalt Poisoning of the Eye from MoM Hip Replacement

Title: Cobalt-Chromium Metallosis With Normal Electroretinogram Background: The popularity of Metal-on-Metal (MoM) hip implants, which are typically made out of cobalt and chromium, has made cobalt poisoning of the eye more common. This condition is called ocular cobalt toxicity. This study focuses on a 66-year-old-man whose vision was damaged because he got cobalt poisoning from […]

Check for Metal Hip Issues if Patient has Cobalt-Related Heart Concern

Title: Unusual Case of Congestive Heart Failure:  Cardiac Magnetic Resonance Imaging and Histopathologic Findings in Cobalt Cardiomyopathy Summary A 69-year-old woman came to the authors with symptoms of congestive heart failure, a heart condition that leads to buildups of fluid in the lungs. She had a history of hypertension, mild kidney problems, and hip replacements […]

Cobalt Toxicity from Metal Hip Causes Vision Damage

Title: Hip ­Implant Related Chorio-­Retinal Cobalt Toxicity Abstract A 39-year-old female with high levels of cobalt in her blood (a side-effect of her two hip implants) came to the doctors with complaints that her left eye had been blurry for three weeks. Eye imaging revealed that the light-sensitive portion of the patient’s retina (called the […]

Biomet Magnum Hips and Heart Problems from High Cobalt Ion Levels

Research Title: Progressive Cardiomyopathy in a Patient with Elevated Cobalt Ion Levels and Bilateral Metal-on-Metal Hip Arthroplasties Abstract: Cobalt poisoning, which is also referred to as cobalt toxicity or cobalt disease, is caused by excessive levels of cobalt in the body. It is a rare but serious possible side effect of Metal-on-Metal (MoM) total hip […]

Adverse Reaction to Metal Debris from Biomet Metal Hip Arthroplasty

Research Title: Adverse Reaction to Metal Debris after ReCap-M2A-Magnum Large-Diameter Head Metal on Metal Total Hip Arthroplasty Background and Purpose: Adverse reaction to metal debris (ARMD) is a type of implant failure that can occur after metal-on-metal hip replacements. The symptoms of ARMD failure may include fluid collections around the hip, a build-up of soft […]

Blood Tests to Diagnose Tissue Death from Metal Hip Problems

Research Title: Adverse Local Tissue Reaction After a Metal-on-Metal Total Hip Prosthesis Without Elevated Serum Metal Ion Levels Background Recent studies show a correlation between high cobalt and chromium levels and failed metal on metal hip (MoM)  implants. Typically a MoM hip patient with cobalt blood levels above 7 parts per billion (ppb) requires follow-up […]

Adverse Reaction to Metal Debris After ReCap-M2A-Magnum Metal Hip

Mokka, J., Junnila, M., Seppanen, M., Virolainen, P., Polonen, T., Vahlberg, T., Mattila, K., Tuominen, E.K.J., Rantakokko, J., Aarimaa, V., Kukkonen, J., Makela, K.T., Acta Orthopaedica 2013; 84(6): 549-554. ABSTRACT: Background and purpose The clinical findings of adverse reaction to metal debris (ARMD) following large-diameter-head metal-on-metal total hip arthroplasty (LDH MoM THA) may include periarticular fluid collections, soft […]

High Chance of Pseudotumors After Large-Diameter Metal Hip Replacement

Abstract: Peri-articular soft-tissue masses or ‘pseudotumors’ can occur after large-diameter metal-on-metal (MoM) resurfacing of the hip and conventional total hip replacement (THR). Our aim was to assess the incidence of pseudotumor formation and to identify risk factors for their formation in a prospective cohort study. A total of 119 patients who underwent 120 MoM THRs […]