Have You Been Injured by an Ancure Stent Graft?

The Ancure Stent Graft was used during endovascular repair of aneurysms, and was thought to be beneficial to patients who were at high risk for adverse outcomes during traditional open surgery. The stent graft also provided an alternative to watchful waiting for patients with aneurysms who were not candidates for surgery. However, in 2001, the devices were recalled and production suspended by the manufacturer, Guidant, due to significant problems with the device.

Use for Ancure Stent Graft

The Ancure Stent Graft was used to treat patients with abdominal aortic  aneurysms (AAA), many of whom were not candidates for open surgery to repair the problem. The use of the stent graft was a minimally invasive procedure, where the graft was placed inside the aneurysm without surgically opening the tissue around it. The graft, a fabric tube with metal hooks, excluded the aneurysm, reducing pressure and providing a new path for the blood to flow while also reducing the chance of a ruptured aneurysm (1).

Problems With Ancure Stent Graft

The FDA reported that Guidant, the manufacturer, acknowledged they failed to report many malfunctions with the device that included severe vessel damage during deployment. In addition, the company failed to report manufacturing changes as required, and an internal audit revealed problems with complaint handling, quality assurance, documentation, and training systems throughout the company. The original warning was issued in 2001, and in 2003, the FDA renewed their concerns regarding problems with the device (2).

Injuries Suffered by Patients

According to court documents filed during proceedings of Guidant subsidiary Endovascular Technologies, there have been 2,628 cases in which the stent system malfunctioned, causing serious injury or death to patients. At least 12 people died as a result of a malfunctioning device, and the FDA reported a 34% failure rate for the Ancure stent graft (3).

Guidant removed the stent from the market in March 2001, but reintroduced it with changes a few months later. In 2003, the product was completely removed from the market after the guilty plea of the subsidiary. For many, the removal of the product was too late, with reports of more than 2,500 injuries and deaths to a dozen patients

 

Sources:

1)   http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100021c.pdf
2)   http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062191.htm
3)   http://www.californiahealthline.org/articles/2003/6/17/guidant-will-no-longer-market-stentgraft-plans-to-exit-aneurysm-treatment-market

 

What You Need To Know About Welding Rod Manganese Exposure

Exposure to manganese welding products, such as welding rods, can have negative effects on your health. Manganeseis often used in welding and is a popular choice of material to prevent corrosion in other materials. The dust created in the process of welding can be inhaled by workers and lead to severe complications. Learn more about the health risks of manganese exposure.

Occupations at Risk of Manganese Exposure
There are several different types of occupations that put workers at risk of manganese exposure. These include welding, mining, and other positions where exposure to metals coated with manganese is prevalent. Welders and other workers who work in tight spaces without proper air filtration are at a higher risk for manganese poisoning, and manganism, also known as welder’s disease.

Manganism 
One of the most common health problems caused by long term exposure to manganese is manganism. It is a serious health condition that can develop after as little as six months of exposure in a work environment (1). Common symptoms include fatigue, loss of appetite, cramps, and reoccurring headaches. These symptoms progress into more serious ones, such as loss of muscle control, dystonia, and stiffness of the muscles. In some cases, individuals with manganism cannot walk without assistance from a walker, or are confined to a wheelchair because of gait-related complications.

Neurological and Behavioral Problems
The Centers for Disease Control and Prevention has found research that points to increased brain and behavioral problems in welders who work with materials such as manganese, lead, and iron (2). In the research studies, welders who were exposed to these materials had lower levels of brain functioning, and decreased motor skills. Noticeable changes in coordination, mood, and memory were also apparent. Welders who inhale manganese dust for prolonged periods of time are also at risk of incurring damage to the central nervous system (1).

Symptoms
Individuals may experience a variety of symptoms after exposure to manganese that can lead to more serious conditions such as Parkinson’s Disease, cancer, and even metal poisoning. Symptoms may not appear immediately after exposure to manganese. They typically develop over time, and can accumulate. Common symptoms include difficulty maintaining balance, walking problems, shaking, slurred speech, mental fog or confusion, and difficulty sleeping. These symptoms are serious, and must be treated immediately to prevent further health complications.

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Sources:

1)    http://www.expertlaw.com/library/environmental_law/manganism.html

2)    http://www.cdc.gov/niosh/topics/welding/

 

Guide To DePuy Hip Replacement Injuries

If you or someone you love were fitted with a DePuy Pinnacle hip replacement or a DePuy ASR hip implant device, you may have experienced adverse complications including metal toxicity, inflammation, pain and the subsequent failure of the implant. In 2010, the DePuy ASR implants were recalled due to their higher-than-anticipated failure rates and a potentially increased risk of complications. If you feel that you are a victim and are experiencing adverse side effects, you may be entitled to file a DePuy hip lawsuit and recover damages for your condition.

DePuy Injuries Lead to Hip Recall
In August 2010, Johnson & Johnson issued a worldwide recall of the DePuy ASR hip implant device, citing data that revealed high numbers of injuries in patients whom had been fitted with the devices. According to the U.S. Food and Drug Administration (FDA), over 93,000 units were removed from the market. Additionally, according to data accumulated from a British national joint registry, an average of 12% of patients fitted with a DePuy ASR device needed to undergo surgery to remove the implant within five years of receiving the device – much less than the anticipated 15- to 20-year lifespan of the implants.

Evidence from the first DePuy ASR lawsuit indicates that executives of the company knew of the potential complications of the devices years before the recall was issued. According to allegations, officials neglected to fix the defective designs of the products due to financial reasons and conducted inadequate testing on the implants prior to releasing them to the market.

DePuy Hip Replacement Injuries
Those with a metal-on-metal Pinnacle hip replacement or DePuy ASR implant may be at an increased risk of early device failure and may require a revision procedure to remove the potentially defective device. Since the implants are made of metal components, these parts have the potential to rub against one another, causing metal debris to shed into patients’ bloodstreams. This metallosis, or metal toxicity, can cause further complications, including:

– Difficult walking or standing
– Pain or inflammation
– Bone fractures
– Damage to the soft tissues
– Metal sensitivity

These complications allegedly stem from the flawed design of the DePuy hip implants. If you have experienced complications, consider seeking legal counsel from professional DePuy hip lawsuit attorneys to file a claim and seek compensation for your condition. While each case is different and a specific settlement amount is not guaranteed, you may be entitled to recover damages for your pain and suffering, loss of quality of life, lost income or loss of earning capacity and medical expenses for additional treatments or revision surgeries you required to remove the allegedly defective implant surgeries.

Sources:
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm

 

Investigation Highlights Problems With Robotic Surgery

In recent years, robotic technology has become popular in operating rooms as a doctor’s aid during surgical operations. One of the most popular manufacturers of robotic medical devices is Intuitive Surgical Inc. The company’s da Vinci robotic surgery system, for example, was used in over 350,000 surgeries in 2012. Despite the adoption of these new systems, a recent investigation conducted by Bloomberg indicates that these robotic tools have caused serious injury for a large number of patients. In addition to the reported injuries, the survey showed that many robotic surgery injuries often go unreported.

Sheena Wilson, now on long-term disability and in need of a third corrective operation after a botched robot-assisted surgery, believes that doctors do not properly explain the risks and complications of robotic medical devices. Wilson says that if she had been aware of the injury risk, she would have never gone through with robot-assisted surgery.

Medical experts argue that the main reason so many injuries occur during surgeries performed with robotic medical tools is that doctors do not receive adequate training with these complex mechanisms. Enrico Benedetti, a surgeon working at a university hospital in Chicago, argues that in many cases, doctors begin using Intuitive Surgical’s tools after just a short training course and a few supervised operations with the devices. In many cases, Benedetti says, this brief training period explains why serious injuries like Sheena Wilson’s occur.

Benedetti’s feelings about lack of training are corroborated by doctors who have written about Intuitive Surgical Inc.’s tools on the company’s website. These medical professionals say that understanding how to use the company’s complex machines is their most pressing problem and go on to explain that these robotic tools have caused many injuries to patients during surgical procedures.
Perhaps even more troubling, though, is that when injuries are incurred via robotic surgery, physicians, surgeons, and doctors frequently fail to properly document and report these issues. In the medical field, the process of reporting this surgical trauma is referred to as “adverse event reporting.”

David Challoner, a Florida-based health professional, argues that the current reporting system in place is disastrously bad. The Food and Drug Administration also indicates that they know about the frequency of misreported or under-reported accidents, and are working diligently to revamp their reporting system.

The investigative report carried out by Bloomberg also suggests that injuries related to robotic medical tools go largely unreported. More specifically, after looking into an FDA report published in 2006, Bloomberg’s report indicates that only 15% of the estimated 1.1 million medical device injuries that occur annually are documented.

Source:

http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html

Need-to-Know Guide to Mirena IUD Injuries

There have been warnings from health experts that the Mirena Intrauterine Device (IUD)  can cause serious injuries to the reproductive organs of women. The number of lawsuits regarding the devices has increased 29% in less than a month. The FDA has advised patients that the IUD can cause a perforation of reproductive organs during the implantation process.

A study from the Society of Laparoendoscopic Surgeons warns that the IUDs from Mirena can become dislodged, causing a perforation to the uterine wall after being placed. In addition, the FDA has received over 70,000 reports of side effects, and at least 6,000 of those involved the device becoming dislocated or the uterus being perforated.

The Mirena IUD releases a small amount of progesterone each day to prevent pregnancy. This affects only the uterus instead of the entire body as with birth control pills. If there are no complications, the device can last as long as five years.

The Mirena website is filled with warnings about using the IUD, listing serious side effects such as pelvic inflammatory disease, sepsis, embedment, and perforation. Some of the possible common side effects include discomfort during placement (which includes dizziness, bleeding, or cramping), and expulsion, where the IUD comes out by itself.

Other serious complications can include missed menstrual periods, changes in bleeding, pelvic, and/or abdominal pain and cysts on the ovaries. Some women complain of a headache or migraine, acne, depression, and heavy or lengthy menstrual bleeding. Other users complain of vaginal discharge, breast pain or tenderness, nausea, nervousness, inflammation of the cervix, vulva, or vagina, back pain, weight increase, decreased sex drive, pain during intercourse, anemia, unusual hair growth or loss, skin irritations, bloating, swelling, and expulsion.

So many patients have suffered Mirena IUD injuries that the numerous lawsuits have been consolidated to a special litigation court in New York. The judge overseeing the litigations has ordered all parties to select test cases by April 4, 2014.

 

Sources:

http://www.prweb.com/releases/2013-mirena-iud/lawsuits-trials/prweb11196254.htm
http://www.mirena-us.com/safety-considerations/