In early June, Medtronic issued an urgent notification to patients and medical professionals concerning a “potential for over or under delivery of insulin if insulin or other fluids contact inside of Medtronic Paradigm Infusion Set Connectors.”
The Food and Drug Administration issued a Class 1 Recall of the orthopedic device known as the LPA Diaphyseal Sleeve. Manufactured by Depuy, Johnson & Johnson’s orthopedic unit, the LPA Diaphyseal Sleeve is used in reconstructive knee surgery.
The Mirena IUD (Intra-Uterine Device) was given FDA approval as a long acting form of birth control and for treatment of heavy menstrual bleeding. It is a T-shaped device that is inserted into a woman’s uterus in order to prevent fertilization. In addition, the device also releases a synthetic form of progesterone known as levonorgestrel, to stop a woman from producing and releasing an egg.
Retrievable inferior vena cava (IVC) filters are a type of vascular filter that is implanted in the heart in order to help prevent life threatening pulmonary embolisms and can be removed when they are no longer necessary. According to the FDA, approximately 200,000 of these devices are implanted into patients each year – many of which – were either most likely not medically necessary in the first place or should have been removed when they were no longer necessary.
Stryker has issued a voluntary recall on its Rejuvenate Modular Hip. While the Stryker Rejuvenate can be used as a component of either metal or ceramic hip implants, the metal on metal modular component can potentially cause fretting and corrosion that may result in pain, swelling, tissue damage and metallosis. The Rejuvenate System can also lead to premature failure due to aseptic loosening and possibly pseudotumor formation.
Biomet Magnum Metal on Metal Hips Can Result in Premature Failure As Well as Chromium-Cobalt Poisoning
The Biomet Magnum hip replacement device is a metal on metal system which includes chromium and cobalt in its composition. The friction caused by the metal components rubbing against one another can result is metal fragment being released into the surrounding tissue and blood stream. These metal fragments can lead to tissue damage including inflammation, bone loss, necrosis, and blood poisoning known as metallosis. Other possible side effects from hip implants include loosening, dislocation and possible fracture.
The AP (6/29, Perrone) reports, "Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles." According to the AP, "the Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million US patients with metal hip replacements." Although the agency "has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices."
We will soon know how juries feel about the conduct of the manufacturers of transvaginal mesh devices. The first case is set to go forward this November 2012 against Johnson & Johnson - Ethicon division over claims that its Gynecare Prolift injured women. Superior Court Judge Carol Higbee will be presiding over this trial.
Knee and Hip Implants: New Not Always Better Than Old?
The ability to move around without pain is something most of us don’t think about, so when patients undergo knee replacement surgery they believe their pain will go away. However, if the patients are still experience pain it could be the result of a fracture, if the replacement was a Smith and Nephew-Journey knee.
Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are not easy subjects for women to talk about. SUI and POP are often the outcomes of weakening muscle tension caused by age or child birth. Stress urinary incontinence is triggered by the weakening of the pelvic muscles, and it can lead an involuntary loss of urine that results from physical activity. Pelvic Organ Prolapse is a condition where a pelvic organ drops and the bulges against the walls of the vagina often protruding outside the vagina.
As women age, they sometimes suffer from a condition called pelvic organ prolapse ("POP"). Some doctors have treated this condition with a medical device called a surgical mesh. These surgical mesh devices - made from the same material as Rubbermaid storage containers - have never been tested on patients. Unfortunately, these untested devices have been found to erode patients' insides, which can result in constant pain and additional operations.
In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn't report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.
Although not yet part of a product-wide recall like the DePuy Orthopedic's metal-on-metal ASR XL Acetabular System and ASR Hip Resurfacing System, Stryker's Cormet metal-on-metal hip system and DePuy's metal-on-metal Pinnacle hip may also cause metalosis, a potentially dangerous and serious condition caused by the metal components of these products grinding up against each other - causing microscopic metal ions (cobalt and chromium) to break off into the surrounding tissues and bloodstream. These hip devices have been implanted in hundreds of thousands of patients over the past several years and their early high failure rates seem like only part of the problem. Perhaps the bigger concern should be this risk of blood toxicity and chromium and cobalt poisoning - the potential adverse effects of which are still being investigated but include soft tissue damage, bone loss and inflammatory reactions. In addition, studies have shown that elevated level may potentially have harmful effects on immunity, reproduction, kidney function, the nervous system and carcinogenisis.
We can now add low magnesium levels to the growing list of side effects caused by Proton Pump Inhibitors (PPIs), like Nexium, Prilosec, Prevacid and Protonix. While PPIs do an incredible job of controlling chronic acid reflux, many researchers now believe that they may also increase your risk of contracting pneumonia, developing bone fractures, (also, see my blog from last Spring), and increasing your risk of a heart attack if taken with a drug like Plavix. It seems as if every couple months, a new warning is issued by the FDA concerning these products.
Urinary Stress Incontinence ("USI") and Pelvic Organ Prolapse ("POP") are relatively common but treatable medical conditions. USI is the loss of bladder control which affects many older women and women following childbirth. POP is a weakening of the muscles and ligaments that support organs like the bladder and uterus and has the potential to be very serious. Traditionally, doctors treated these conditions without mesh in a procedure called an abdominal sacrocpopexy which uses the patient's own ligaments to support weakened muscles. More recently, an increasing number of gynecological and urological surgeons have been using vaginal mesh and sling devices. It was thought that transvagnial mesh would lead to better outcomes; however, a recent study concluded that not only was this traditional surgery just as effective as the mesh, but there were significantly more complications and side effects as a result of using mesh.
Lawsuit filed against Wright Medical Technology for Profemur Z Stem Hip Implant - Reports show 11.2% Failure Rate
The recent failures and recalls of the Durom Cup hip implant and DePuy's ASR hip system, including the ASR XL Acetabular system and the ASR Hip Resurfacing System, have brought the efficacy of hip implants into the public spotlight. It should be no surprise then that the failures of yet another hip implant are coming into focus.
The Zimmer NexGen knee is a 'high-flex' porous femoral component that attaches to the bottom of the thighbone instead of using cement to keep the knee replacements in place. Beginning in April, 2010, surgeons began calling for recalls of the devices, based on a dangerously high failure rate, resulting in revision surgeries or close monitoring for radiographic loosening of the knees.
Yesterday, the FDA issued a safety alert for Bard Recovery and Bard G2 filters, inferior vena cava (IVC) filters, manufactured by C.R. Bard. These filters are small devices that are implanted in to the inferior vena cava, the main blood vessel that returns blood from the lower half of the body, to prevent pulmonary embolism. The filters prevent blood clots from reaching the lungs where they would become fatal. Over the last five years, there have been 921 adverse event reports involving IVC filters - 328 cases where the device migrated in the body, 146 cases involving a detachment of a device component, 70 cases involving perforation, and 56 cases where the filter fractured. According to the FDA, many of these events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of a blood clot or pulmonary embolism has subsided.
FDA Orders Baxter To Pay Refunds To Purchasers Of its Colleague Volumetric Infusion Pumps: Will You Get Your Refund?
On April 30, 2010, the FDA ordered Baxter Healthcare Corp. to recall and destroy all of its more than 200,000 Baxter Colleague Infusion Pumps due to Baxter’s longstanding failure to correct serious safety problems with the Infusion pumps. These pumps are medical devices designed to deliver fluids, nutrients and medication to patients in a controlled manner. They are widely used by health care practitioners in order to more accurately deliver medications to patients. More than 500 deaths and 56,000 adverse events associated with these infusion pumps have been reported to the FDA in the last five years.
According to The Wall Street Journal, the FDA is becoming increasingly concerned about the continuing and increasing number of hardware and software problems associated with insulin pumps, small devices worn by many diabetics to continuously deliver insulin, as an alternative to shots. Incredibly, over the last five years, there have been 18 recalls of insulin pumps, including recalls by manufacturers Johnson & Johnson, Medtronic, Inc., and Roche Holding AG. Tomorrow, the FDA is convening an advisory panel of experts to discuss what needs to be done to “minimize risks associated with the devices in these situations."
In October, we alerted readers that the FDA became aware of numerous radiation overexposures during CT scans at a particular facility, with patients receiving radiation doses that were approximately eight times the expected level. The article noted that this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility - putting patients at increased risk for long-term radiation effects.
In August 2009, Medtronic began informing physicians for the first time that, contrary to the labeling, its Sutureless Connector (SC) intrathecal catheters were incompatible with IsoMed Infusion Pump Model 8472, a drug delivery system for which the catheters were not designed. On September 14, 2009, the US Food and Drug Administration ("FDA") notified Medtronic that it considers the notification a Class I medical device recall, the strongest notice that the FDA can issue, because accidental use of the catheters with the wrong pump may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. This incompatibility is a design defect and not a result of how the pump is implanted. In fact, it may appear to be connected and secured, but a physical interference between the catheter and the infusion pump may lead to fluids leaking into surrounding tissues and the proper dose of drugs not being delivered.
Zimmer Holdings, the nation's top artificial joint component manufacturer recently announced that it is re-releasing its Durom Acetabular Cup, a hip replacement part, to doctors again, but only to those who complete special training on its use. This announcement comes after sales of the Durom Cup were suspended by Zimmer in July 2008 after reports that the component was defective and failed to bond in many patients, thereby causing patients to undergo painful revision surgeries. Approximately 12,000 patients had the Zimmer Durom Cup system implanted between 2006 and 2008, and accordingly to Zimmer's own research estimates, almost 8% of the people that received the initial hip replacement required a revision surgery withing a two year period. The high failure rate is caused by the Durom Cup's inability to bond with the host bone, causing the implanted part to loosen and move.
We have previously reported here that pain pumps used on patients' shoulders post-operatively have led to an increasing number of cases of PAGCL, or postarthroscopic glenohumeral chondrolysis. In fact, almost 63% of patients on which a pain pump was used following shoulder surgery may develop PAGCL. Many patients, however, are reporting problems obtaining the correct diagnosis for their injury and have not been apprised by their doctors of the relationship that exists between their continuous shoulder problems and the pain pump that was used on their shoulder following surgery.
The Bard® PerFix® Plug, introduced by Davol, Inc. and C.R. Bard, Inc., in 1993, is a medical device used to repair “primary and recurrent inguinal hernias.”
On September 26, 2008, the FDA issued a Class-1 Recall of all Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters.
On August 15, 2008, the U.S. Food and Drug Administration (FDA) announced a Class 1 Recall of Boston Scientific’s NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system “because the tip of the stent-delivery system may detach during the procedure.”