defective medical device -

Devices that are used to measure vital statistics in order to allow doctors to make an accurate diagnosis have been recalled due to a risk that the results shown will be incorrect.

The items in question are called Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays.  These products, which were distributed by Roche Diagnostics Operations, are supposed to allow doctors to gauge the amount of heart damage in an individual.  Being able to accurately determine the degree of damage can assist a physician with diagnosing a heart attack.

The problem with these recalled items is that the test results that doctors are looking at might show inappropriately low levels of Troponin I with certain plasma samples.  In fact, it could show levels 50% lower than the actual amount of Troponin I.  This could lead to death or a number of adverse consequences for the patient.

The recall affects lots 163176 and 163177.  Affected customers should have received a letter about the issue after March 12.  That letter was entitled “URGENT MEDICAL DEVICE REMOVAL.”  The product should be discontinued and the instructions of the letter heeded.  Doctors and patients alike are being asked to report to Medwatch should an injurious incident occur.

I tried as a personal injury lawyer in Fresno to break this very technical recall down in a way that’s easy to follow.  The truth is, medical device recalls are some of the most important out there, and we shouldn’t refrain from reporting them just because the jargon is challenging.  I hope as a San Francisco personal injury attorney that the technical nature of this recall doesn’t prevent news outlets from reporting the issue.

The U.S. Food and Drug Administration has issued a report announcing their recommendation that transvaginal mesh devices be re-classified as a high risk medical device, according to news sources. The FDA is requiring new safety statistics be submitted by the manufacturer in order for the product to remain on the market.

A panel will meet next week to decide if the reclassification for the device, which is used for pelvic organ prolapsed and stress urinary incontinence.

While currently classified as “moderate risk,” the FDA has issued three separate warnings since 2008 after thousands of complaints were received as well as reports of fatalities. The FDA has also stated that the mesh does not provide more benefits than surgery.

Complications include mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, and recurrence of POP and/or SUI.

As a Los Angeles product defect lawyer, I hope the FDA can make a recommendation that is in the best interest of the patient. A patient has the right to be informed of the risk they are undergoing when they choose to utilize any medical device. If you’ve been injured by a medical device, it’s important to contact a personal injury lawyer as soon as possible because you may be entitled to monetary compensation as a result of getting injured because of a defective or recalled product. The longer you take to contact someone, the more evidence is lost.

The Food and Drug Administration is warning patients against using Medtronic pumps because they may fail to deliver drugs, according to news sources.

The specific drug pumps are used to administer drugs to treat chronic pains and spasms, among other conditions. The defective issue is caused by a film that forms over the battery.

The FDA has classified this recall as a class-one, which means that serious harm could come of using these devices. Doctors were first alerted to the malfunction in July. The design of the device has been updated since then.

The product subject to recall is SynchroMed II Implantable pumps, models 8637-40. They were dispersed from 2004 until July 2011.

If you have one of these devices implanted, it is not recommended that you get it removed. See your doctor if you have issues or if the device sounds the alarm.

At our Los Angeles personal injury law firm consumer health is of the utmost importance to us. We know that even with all of the rules and regulations imposed on product manufacturers, things can still go wrong and sometimes companies even put profit before safety. If you or a loved one has been affected by a failed medical device please do not hesitate to call a product liability lawyer right away. The longer you wait the more chance you have of losing evidence for your potential product liability case.

A new study points to batteries as the leading problem when it comes to automated external defibrillator (AED) failures, according to news sources.

The study, published in the Annals of Emergency Medicine, reported that in the last 15 years, AED failures have been linked to 1,150 deaths. Of these, 1 in 4 were battery related failures. The study analyzed 41,000 reports of AED problems.

Other issues included wiring and connectivity malfunctions.

AED can be crucial in saving a life before emergency personnel can arrive, as statistics show that the likelihood of a heart starting again drops by 7-10 percent with every passing minute.

While industry professionals point out that AED devices usually work, they would like to see changes implemented that would make the device more reliable. For example, a design that would make new software available for download via computer that would also run a test to make sure they’re working properly.

Experts also point out that it’s crucial to report when a medical device fails so that problems can be fixed for the future. They recommend testing the device habitually.

As a personal injury lawyer in Los Angeles, I hope that the FDA can come up with a solution to ensure that AEDs are doing their job. A family member of someone who was in need of one, only to find it wasn’t working, should never have to wonder “what if?” As a product defect lawyer, I hope we see these changes soon.

News sources report, that Medtronic Inc. issued a class 1 recall Monday of its SynchroMed II implantable drug infusion pump, making this the second such recall of the product this year.

The recalled pumps have an issue with the battery that can lead to sudden failure of the device. Class 1 recalls are reserved for the most severe of situations—those deemed probable for serious adverse consequences or death. The implantable pumps are part of the SynchroMed system that stores medication and delivers it to a specific site. A sudden failure of the device can cause a patient to experience a return of pain or symptoms or withdrawal symptoms.

In mid-July Medtronic issued an urgent warning about the pumps, stating that there had been 55 confirmed cases of the devices shutting down due to faulty batteries. It is suspected that the formation of a filmy substance within the battery caused the sudden shut down of the medical devices.

As a product defect lawyer, patient safety is something I am very aware of. I hope that everyone impacted by this faulty drug pump is receiving the proper care and support they deserve. Because of my experience as a product liability lawyer, I know that people rely on their medical devices functioning properly to maintain their health and, in some cases, sustain their lives. I encourage anyone who suspects they might be affected by the SynchroMed II recall to contact their physician right away.

The U.S. Food and Drug Administration announced in a news release Friday that Vital Signs Devices, a GE Healthcare Company, has initiated what the company is calling a “voluntary worldwide field correction” of a medical humidifier due to a defect that may cause insufficient oxygen to reach a patient.

The field correction, which the FDA has classified as a Class I recall, is of the Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier) stems from a possible occlusion that can impede the proper flow of oxygen or medicinal gases to a patient. The unit may be sold individually or included with Vital Signs anesthesia circuits. The humidifiers affected by the recall were sold between January 2011 and April 2011.

GE Healthcare began the recall in April, notifying customers through an Urgent Medical Device Correction letter and making follow-up calls to confirm that the letter was received. Customers were told of the problem, given safety instructions, and told not to use anesthesia circuits containing the defective humidifier or the stand-alone device for specific product item and lot numbers. Customers were instructed to contact Vitals Signs Customer Service to arrange the return and replacement of the products. All affected humidifiers and anesthesia breathing circuits with affected humidifiers are being replaced.

The FDA’s Class I recall classification places the field correction in a group of recalls considered “a situation in which there is a reasonable probability that the use of or exposure to the volatile product will cause serious adverse health consequences or death.”

As a Los Angeles personal injury lawyer, I hope that no patients have been harmed through the use of the defective humidifiers.

News sources say that, according to the FDA, in 2010, doctors performed more than 100,000 prolapse repairs using surgical mesh, and about 75 percent of them were transvaginal. Between 2005 and 2007, the agency received more than 1,000 reports of adverse events related to the mesh in women diagnosed with pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first announced the safety concerns surrounding the device, to 2010, the FDA received almost 3,000 more.

The agency stated, “Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse events reports remains high.”

But that doesn’t mean that the agency plans on pulling the device form the market. Dr. William Maisel, deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health, said, “We don’t think transvaginal mesh should be routinely used for pelvic organ prolapse repair. But we do not regulate the practuce of medicine, and we do recognize that some patients really do need mesh.

Urogynecologist with the University of Utah, Dr. Ingrid Nygaard, claims she sees roughly two new patients a week with complications from mesh. Some are unable to be successfully treated, and according to her, “that’s a big tradeoff for a procedure that has uncertain effectiveness.” She said that surgeons that implant mesh generally mean well, because other procedures have a 10 to 20 percent failure rate.

Dr. David Grimes, who is board certified in obstetrics, gynecology and preventative medicine and a distinguished scientist at the global development organization FHI360, is less certain about the nobility of surgeon’s intentions.

“The problem is the surgeons,” Grimes said. “This is industry-driven technology. We have a long history of accepting things without critical appraisal. What we need are better standards not just within the FDA, but within the professional community.”

But conducting studies of devices like surgical mesh can be huge, lengthy and expensive tasks. Grimes said, “It’s easier to do studies of pills than it is to do studies of surgical techniques.”

Urogynecologist at the Washington Hospital Center in Washington, D.C. Dr. Cheryl Iglesia attempted such a study but was forced to cut it short. She and coauthors published their findings from a trial where they randomly assigned 65 women to transvaginal repair of prolapse with or without mesh in the journal Obstetrics & Gynecology last year. They found that after three months, the mesh had eroded in almost one in six of the women that received it. In addition, cure rates and quality of life were no different between the mesh and no-mesh study groups. This prompted questions as to the value of the device in such procedures.

A spokesman for the mesh manufacturer Ethicon, a Johnson & Johnson company, said that mesh is “an important option for many patients” when treat pelvic organ prolapse and stress urinary incontinence. Ethicon spokesman Matthew Johnson said, “Potential complications and risks are disclosed in our product labeling and discussed in our professional education and promotional literature.”

A registry of transvaginal mesh patients is in the works, however, in order to avoid skewing the data towards patients with complications, patients like Janet Holt and tens of thousands of other women already living with complications from surgical mesh will be left off.

As a Los Angeles wrongful death attorney, I hope this has helped shed some light on a very important subject.

Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they age.

Her doctor claimed he could fix the condition by creating a kind of “nest” to hold her organs in place. Holt doesn’t recall him ever telling her that he would use surgical mesh to do so. But, he was the doctor, so Holt, a 50-year-old from San Antonion, TX, allowed the operation.

More than four years later the medical device implanted to help her has created many new problems for Holt, sparking constant pain and requiring seven more operations while surgeons attempted to remove the mesh, which had eroded into her vagina, piece by piece.

Holt’s case has now become the centerpiece cited in concerns about the government process that allows medical devices, like surgical mesh made from the same material as Rubbermaid containers, to be used and implanted in patients with no previous testing.

Holt, now 54, has had to cut back working in her family’s five restaurants, can no longer ride horses and can no longer play baseball with her grandson. She said, “I don’t think I’m going to get any better.”

Many medical devices are not bound by the restrictions of prescription drugs, which have to be proven safe and effective before they’re sent to market. Only about 10 percent of medical devices, the ones deemed to have the highest risk like breast implants and implantable pacemakers, are required to be tested on humans before they are distributed for large scale use. Surgical mesh that is used to support organs that slip out of place over time does not fit into that category. But that may be changing soon.

The FDA was spurred into initiating their second warning concerning the device in less than three years due to the growing number of surgical mesh-associated complications in women. The agency will convene a panel of outside experts later this year to advise whether more rigorous testing should be done to the mesh.

The Institute of Medicine, an independent nonprofit group that advises policymakers as well as the public, is issuing a major report on whether the approval process of these devices optimally protects patients and promotes innovation to better public health. But it’s not just surgical mesh that they’re focusing on. A recent analysis of recalls spared concerns over how the FDA clears thousands of devices to be used. The study focused on 113 recalls from 2005 through 2009 for devices that the FDA found could cause potentially serious health problems or death.

Of those devices, only 21 were required to have been tested on patients prior to receiving FDA approval. Manufacturers of 80 recalled devices were only responsible for showing how they were similar to devices already on the market to get approval through the FDA’s 510(k) approval process. The eight remaining devices weren’t required to undergo any FDA review at all.

“Consumers are justifiably upset when their cars, toasters, and baby food bottles are recalled. Recalls makes us all question the safety of the products we take for granted. But what about the products permanently implanted inside our bodies?” asked Dr. Rita Redberg and Dr. Sanket Dhruva of the University of California, San Francisco. They added that many patients assume that the implants have been thoroughly tested before becoming available. “It is sad and troubling to learn that we cannot count on this assurance for some medical devices.”

The FDA’s most recent warning said complications associated with surgical mesh in procedures like Holt’s are a continuing area of concern. The FDA emphasized, “Serious complications are not rare.”

The warning specifically noted mesh implanted through the vagina instead of the abdomen to fix pelvic organ prolapse or stress urinary incontinence, urine leakage during physical activity.

As a Los Angeles wrongful death attorney, I feel this is an important issue and hope to help shed some light on the subject. More on this in tomorrow’s blog.