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Category Archives: Devices

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Summary: Viewpoints on the Nuances of IVC Filter Usage

Posted in Devices, IVC Filters

Endovascular Today published an article in July 2014 in which three doctors well-versed in dealing with inferior vena cava (IVC) filters were interviewed for their opinions on indications, patient follow-up & retrieval rates and the prophylactic use of the devices. The three interviewees were: •    Dr. William T. Kuo, MD, FSIR, FCCP FCIRSE; Director, Interventional… Continue Reading

Summary: Inferior Vena Cava Filters in the United States: Less is More

Posted in Devices, IVC Filters

In an article published in the International Journal of Cardiology in 2014, Drs. Mohamad Alkhouli and Riyaz Bashir question the efficacy of the inferior vena cava (IVC) filter as a device for routine use and raise cautions about the apparent lack of retrieval of these temporary filters, particularly in U.S. patients. There is little doubt… Continue Reading

2012 – 50% of IVC Filters Fail

Posted in IVC Filters

In 2012 the Journal of the American Medical Association published an article titled “Frequent Fracture of TrapEase Inferior Vena Cava Filters,” providing further insight into one serious side effect related to the use of IVC filters. Inferior vena cava (IVC) filters are small metal filters placed within the vena cava vein used to trap blood… Continue Reading

IVC Filters: 86% Exhibit Serious Side Effects

Posted in IVC Filters

In 2012, a team of researchers from the Department of Radiology and Biomedical Imaging at the University of California, San Francisco published an article that illustrated some serious risks associated with the use of IVC filters. Inferior vena cava filters are small metal filters inserted into the inferior vena cava vein, used in patients with… Continue Reading

2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic… Continue Reading

2011 – 32% of Metal-on-Metal Hip Replacement Patients Endure Pseudotumors

Posted in DePuy Hip Replacement

A 2011 article by D.H. Williams et al. published in that year’s December edition of Journal of Bone and Joint Surgery (US) titled “Prevalence of pseudotumor in asymptomatic patients after metal-on-metal hip arthroplasty.” sheds further important insight into the tendency for metal-on-metal hip replacements to release dangerous metal ions into the bloodstream. One result of… Continue Reading

2012 – 40% of metal-on-metal hip replacement patients face adverse reaction to metal debris

Posted in DePuy Hip Replacement

A 2012 article by I.A. Malek et al. published in Journal of Bone and Joint Surgery titled “The sensitivity, specificity and predictive values of raised plasma metal ion levels in the diagnosis of adverse reaction to metal debris in symptomatic patients with a metal-on-metal arthroplasty of the hip.” helps demonstrate the rate at which patients… Continue Reading

FDA Proposes Change of Vaginal Mesh Classification

Posted in Vaginal Mesh

According to the Federal Register (05/01/2014), “the Daily Journal of the United States Government,” the United States Food and Drug Administration has recently called to reclassify transvaginal mesh in the repair of pelvic organ prolapse, an ailment that affects about 50% of women, even if only to a small extent. The Register states that the… Continue Reading

Investigation Launched into Whether Johnson & Johnson Obstructed Justice and Tampered with Evidence by Deliberately Destroying Records

Posted in Vaginal Mesh

Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them. As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that… Continue Reading

2014 – 35% of patients suffer complications with robotic-assisted surgery

Posted in Surgical Robots

In January 2014, the results of a study by D. Ramzy et al. titled “Three hundred robotic-assisted mitral valve repairs: the Cedars-Sinai experience.” in Journal of thoracic and cardiovascular surgery that evaluated the relative safety and efficacy of robotic-assisted surgery for the repair of the heart’s mitral valve. The surgeries evaluated in this study were… Continue Reading

2014 – More complications, longer operating times with robotic-assisted surgery

Posted in Surgical Robots

In 2014, a study was published in Annals of Surgical Oncology by BH Lang et al. titled “A Systematic Review and Meta-analysis Comparing Surgically-Related Complications between Robotic-Assisted Thyroidectomy and Conventional Open Thyroidectomy.” that aimed to determine the relative safety of robotic-assisted by conventional thyroidectomy. For this study, researchers reviewed 11 previously-conducted studies and used statistics… Continue Reading

Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents

Posted in Vaginal Mesh

Part I: Destroying Valentine’s Day Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to… Continue Reading

Verdict in Favor of Ethicon: No Big Win in the Grand Scheme of Things

Posted in Vaginal Mesh

Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has… Continue Reading

2014 – Serious ailment likely the result of surgical robots

Posted in Surgical Robots

An article published in the January-February, 2014 edition of Female pelvic medicine and reconstructive surgery titled “Pneumomediastinum after robotic sacrocolpopexy.” reviews a case of pneumomediastinum in a woman who underwent robot-assisted surgery for the repair of posthysterectomy prolapse.  The team writes “Pneumomediastinum is a rare but potential complication of laparoscopy that is related to insufflation… Continue Reading

2012 – Actos raises risk for bladder cancer 15-40%

Posted in Surgical Robots

In 2012, an article titled “Use of thiazolidinediones and the risk of bladder cancer among people with type 2 diabetes: a meta-analysis.” was published by IN Colmers et al. in Canadian Medical Association Journal investigating the relationship between Actos and bladder cancer.  Thiazolidinediones are a class of diabetes drugs including pioglitazone, the chemical name for… Continue Reading

2013 – 21% complication rate with robot-assisted surgery

Posted in Surgical Robots

In the December, 2013 edition of European Urology, a team of researchers led by RK Kumar published the results of a study titled “Robot-assisted Partial Nephrectomy in Patients with Baseline Chronic Kidney Disease: A Multi-institutional Propensity Score-Matched Analysis.” that aimed to evaluate the relative safety of robot-assisted nephrectomy, as compared with a traditional approach that… Continue Reading

2014 – Longer operating time, more pain with surgical robots

Posted in Surgical Robots

A recent article published in the January 2014 edition of Obstetrics and Gynecology titled “Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.” lives up to its title and compares the safety and efficacy of robot-assisted to traditional sacrocolpoplexy. The team, led by JT Anger, writes “Laparoscopic and robotic sacrocolpopexy are widely used for pelvic… Continue Reading

2014 – High rate of complications seen with robot-assisted surgery

Posted in Surgical Robots

In 2014, an article by AM Coker et al. titled “Outcomes of robotic-assisted transhiatal esophagectomy for esophageal cancer after neoadjuvant chemoradiation.” in Journal of Laparoendoscopic & Advanced Surgical Techniques aimed to “determine if [robotic-assisted transhiatal esophagectomy (RATE)] could be performed safely with good outcomes for esophageal cancer in a more recent series of patients”. The… Continue Reading

2013 – 20% complication rate seen with surgical robots

Posted in Surgical Robots

In a 2013 article published in the December issue of Journal of Gastric Cancer titled “Emerging Role of Robot-assisted Gastrectomy: Analysis of Consecutive 200 Cases.”, a team of researchers led by JY Park “aimed to evaluate whether gaining experience in robotic gastrectomy could improve surgical outcomes in the treatment of gastric cancer.”  In recent years,… Continue Reading

2014 – Study finds surgical robots “introduce the risk of new complications”

Posted in Surgical Robots

An article published earlier this month (February 2014) titled “Systematic Review and Meta-analysis of Robotic vs Conventional Thyroidectomy Approaches for Thyroid Disease.” by GH Sun et al. in Otolaryngology provides us with helpful insight into the relative safety and efficacy of surgical robots, which have become increasingly prevalent in the modern operating room, at least… Continue Reading

2004 – 53% of LAP-BAND patients underwent reoperation

Posted in Allergan LAP-BAND

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device… Continue Reading