FDA ALARMED BY DA VINCI INCIDENTS, SURVEYS HOSPITALS

The Da Vinci surgical system has been under a barrage of pressure from all sides. On one end, a long list of adverse event reports are racked over it, followed by a burgeoning line of lawsuits against its manufacturer. Recently, the FDA is making rounds, sponsoring a survey to measure surgeon training and other complications related to the device in key medical centers and hospitals nationwide. Many conclude the future is bleak for this particular surgical care technology, Bloomberg reports.

A published March 1, 2013 article stipulates that the FDA is reaching out to various surgeons in top U.S. hospitals. The agency is gathering data from these health professionals on a list of criteria regarding Intuitive Surgical, Inc., maker of the Da Vinci surgical system.

The Da Vinci Surgical System Matters Looked Into

Although costing roughly $1.5 million each, the Da Vinci surgical system has been used in over 500,000 surgical procedures in 2012 alone. However, lawsuits against its manufacturer over the device have been climbing steadily.

Given the number of operations, doctors were then surveyed on what particular type of surgery they think the Da Vinci best and least fits. Also, the query wanted to know what kind of training these doctors have undergone to use the device.

Da Vinci Adverse Events Report Reach Alarming Numbers

Approved in 2000, the Da Vinci surgical system has been utilized to aid in gynecologic, urologic and laparoscopic surgery. The surgical robot has also been used to perform thyroid cancer procedures, gastric bypass surgery and gall bladder removal.

News of the survey was announced after Da Vinci adverse event reports swelled. In its report last January, hedge fund Citron Research detailed that roughly 4,600 reports of adverse events have been made because of the Da Vinci. FDA’s MAUDE database reveals that 3,900 of these reports were forwarded between the period of 2007 and 2012.

Da Vinci Lawsuits Claimed Serious Adverse Effects

Patients who have decided to file a Da Vinci surgical system lawsuit have done so because of the following adverse effects:

- excessive bleeding

- bowel Injuries
- cut ureters
- surgical tears/burns to arteries(other blood vessels)
- surgical tears/burns to vital organs
- death

The FDA is trying to get to the bottom of the matter. It wants to know if the long list of adverse reports is caused by the Da Vinci device itself or if there are other issues involved, according to an FDA spokeswoman, Bloomberg.com reported.

Considering Proper Compensation for Da Vinci Injuries

Getting injuries right from the surgical table is no joke. It is for this reason that seeking due compensation through a Da Vinci surgical system lawsuit could be a viable option.  An experienced personal injury lawyer should be able look into the merits of one’s case. Also, trusted sites, e.g.   www.rotlaw.com of RLG (Rottenstein Law Group), can give a free online legal review that could jumpstart one’s lawsuit over Da Vinci surgical system in no time at all.

Da Vinci Surgical System on Review

This is a very sophisticated machine no doubt. But allegedly, many of its results have been spectacularly disastrous.

The Da Vinci surgical system allows surgeons to operate from a distance through a control panel. By looking into a couple of stereo eyepieces and using foot pedals and hand controls, an operating surgeon is able to navigate the arm of the robot. This is possible since the robotic arm is equipped with cameras and surgical tools. The Da Vinci promises surgery that is less invasive, recovery time that is quicker and a motions benefit way beyond what a human hand can do.

All these benefits, however, have drawbacks. Many complications that are very serious and are possibly life-threatening have been attributed to the Da Vinci surgical system.  The device is said to be defective; the learning curve in operating the device is allegedly way too steep.

Da Vinci Allegedly Offers no Distinct Advantage

From the Da Vinci company website, the device is trumpeted as an alternative surgery that is minimally invasive for treating various health conditions. These conditions include: obesity, kidney disorders, heavy uterine bleeding, endometriosis, coronary artery disease, prostate cancer, kidney cancer, bladder cancer among many other diseases.

However, over time, a lot of people began asking if real benefits over traditional surgery exist from the Da Vinci surgical system. For instance, both the American College of Obstetricians and Gynecologists and the Kaiser Foundation have cast doubt on the system. Further, the Journal of Clinical Oncology January 2012 issue has stated that it seems using the device has no distinct advantage over traditional surgery. To note, a surgery via the robot costs $1,300.

Da Vinci is linked to Many Complications

Worse, many patients have not been warned adequately. They do not know that it takes some time before a surgeon becomes proficient in using the device. And that while the surgeon is learning the dangers of serious injuries that could be life-threatening abound. Some of these are:

-        Tears or punctures
-        More surgery
-        Surgical burns
-        Fatal complications

Getting Proper Compensation for Da Vinci Injuries

Individuals who have been experiencing problems due to the Da Vinci surgical system has an option of seeking financial relief through a Da Vinci surgical system lawsuit. Getting the merits of one’s case evaluated by an experienced personal injury lawyer is a good start. Those who suffer need not look very far to get their lawsuit over the Da Vinci surgical system moving. Sites such as www.rotlaw.com , a service-website of RLG (Rottenstein Law Group), offer legal evaluations online at no cost.

This is one powerful cutting device. Wielding it improperly could be deadly.

Da Vinci Surgical System Complications

This surgical system seems revolutionary. But its alleged complications have sent some people in pain and largely in shock.

Da Vinci surgical system is a four-armed robotic device that is remotely-operated by surgeons using foot pedals and joysticks. The device was intended to make surgery less invasive and more accurate. Because of its sophistication many think that recovery time for surgeries using the Da Vinci is shorter and many complications brought by the limits of the human surgeon directly operating are minimized. To a large extent it seems this device is predestined to replace operation by a human surgeon.

However, the Da Vinci surgical system received a lot of flak over time. First among the list is excessive cost, then other issues like under-trained surgeons and unsubstantiated benefits follow. Reports of people dying after or during operation have also surfaced.

Da Vinci and its Operation has a Large Price Tag

Seattle Times has reported that a Da Vinci surgical system can cost hospitals as much as $2.6 million. Many critics believe that robotic surgery does not offer an improved outcome and is just the result of a perceived “medical arms race” between hospitals.
On the other hand, patients being operated by the device in a robotic hysterectomy can pay $1,300 more on average with no clear cut benefits when compared to traditional surgeries. This was revealed in the January 2012 issue of the Journal of Clinical Oncology.

Da Vinci Operation Might Have Serious Complications

One concern that has been raised in the Seattle Times is the fact that no national standardized testing has been done to ensure health professionals operating the device are proficient enough. Intuitive Surgical provides training using a cadaver which could run for three to four days. However, cadavers and a living patient are way too different from each other.

Several patients who had a surgery using the Da Vinci robot came home to discover various serious adverse effects have plagued them. Some of these complications are:

-        Over-anesthetization
-        Excessive bleeding
-        Internal burns on organs and one’s blood vessels
-        Internal lacerations to one’s arm
-        Death.

Lawsuits Over Da Vinci Robot Injuries are Adding Up

In March of 2012, an Illinois jury awarded the family of a patient $7.5 million after determining that there was negligence on the part of a surgeon who used the Da Vinci for surgery. Sadly, it was the first time the surgeon utilized the device resulting in the patient dying on the operating table.

There is a proper way to filing a claim. If one has been operated using the Da Vinci surgical system and has sustained injuries, one maybe worthy of just compensation.

Filing one’s Da Vinci surgical system lawsuit need an experienced personal injury lawyer to iron things out. To a large extent, the internet has played a key role in making lawsuits over Da Vinci  surgical system happen, giving free legal help in sites like www.rotlaw.com of the Rottenstein Law Group (RLG), for instance.

Truly, Da Vinci is a very powerful machine. Such power could be dangerous without proper controls.

Metal-on-Metal Implants Scrutinized by FDA

It seems the government body is making headway towards policing these devices. However, many feel this has been long overdue.

On 17th of January 2013, a safety communication on metal-on-metal hip implants was issued by the FDA. The agency is set on updating various complications that has come to plague the device. Further, the government body stipulates that metal-on-metal implants could be risky due to the friction that occur between components. These implants, having both an all-metal ball and cup, can release tiny particles of metal when a patient moves or walks. In turn these particles can find its way to the bones and tissue of a patient causing damage.

Metal-on-metal Adverse Effects

With metal-on-metal hip implant, metal debris flake off from the device causing damage to surrounding tissues and bone. If largely unchecked this phenomenon can result to metallosis, or metal poisoning. More often than not, these complications lead to revision surgery as the pain gets more severe in time.

Many companies have manufactured metal-on-metal hip implant. One of them is Stryker. Patients who have decided to have Stryker’s implant should be aware of the initial signs of hip failure which could lead to a revision surgery.

One of the most obvious of these symptoms is pain accompanied by inflammation. On the other hand, metallosis can also affect other functions of the body such as the thyroid gland of a patient. Also, other side effects like neck discomfort, fatigue, weight gain and the distinct incapability to control one’s body temperature may also surface.

More Pronounced Risk for Some Patients

The FDA safety communication also listed out various factors that could increase the chances of a patient of suffering from the complications of a metal-on-metal implant. To note these are some of the listed factors:

-        Physically active
-        Female
-        Overweight  
-        Had had kidney failure, and
-        Have sensitivity to certain metals

Added to these, those who are taking corticosteroids are also at greater risk. So are those whose immune system have been suppressed.

Getting Justice for Metal-on-Metal Injuries

It is but righteous that one file a claim for injuries suffered from a metal-on-metal hip implant like DePuy. However, there is a need to do things right as there are requirements in seeking compensation through a DePuy Pinnacle lawsuit.

Getting the services of an experienced personal injury lawyer could be the best decision a justice-seeker can make. In this regard, many have sought the internet to give them access to the proven expertise, in rotlaw.com of the Rottenstein Law Group (RLG), for instance.

It is always good to hear of government watchdogs working to protect the people’s interest. It is just sad to note that thousands have already suffered.

Metallosis from Pinnace Hip Implant Triggers Woman to Sue DePuy

She complains of metal micro flakes invading her very system from the inside.  And, with this, came a host of seemingly unending pains.

 

On the 28th day of December  2012, a hip lawsuit against Pinnacle was filed by Lisa Payne. She alleged that the Pinnacle hip implant has given her injuries, causing her to suffer from metallosis. Filed in the U.S. District Court for the Eastern District of California, said the lawsuit has multiple defendants namely:  Johnson & Johnson Inc., DePuyOrthopaedics Inc., Johnson & Johnson Services Inc. and a physician named  Thomas P. Schmalzried.

Metal Poisoning  from Metal-on-Metal Rubbing

On May 10, 2009 Payne had her DePuy Pinnacle Hip Replacement System implanted.  According to the complaint, it was not long after said hip surgery that her ordeal began. She started experiencing severe pain. Added to this, she had loosening of the implant,  causing her instability.

Worse, she became a victim of metal poisoning which developed after toxic metal particles flaked off and got deposited into her tissues and bones through the bloodstream. This is caused by the metal-on-metal components of the hip implant clashing upon each other.

Pinnacle Lacks Adequate Safety Testing, Lawsuit Charges

The lawsuit alleges that Pinnacle lacked adequate safety testing before seeing the market. The hip implant  was able to get through the FDA because of the 501(k) process which allows products that are “substantially equivalent” to already approved products to pass.

And the complaint asserts that if the Pinnacle had been properly tested, DePuy would have been able to know about the complications of the device before it was launched. Specifically, the manufacturer should have been aware of metallosis,  a complication found  in many patients using the hip implant.

Study Reveals High Rates of Failure for Metal Implants

Many, not only Payne, are suffering from the complications of metal-on-metal hip implants. This has been revealed in a British study involving  400,000  hip replacement surgeries which transpired from the year 2003 up to 2011.

The study showed that in a span of five years, 6 percent of the total metal implants failed while only 1.6 percent of ceramic or plastic implants failed. In conclusion, the study stipulated that metal-on-metal implants should “not be implanted” because of its poor survival rate.

Plaintiff is seeking punitive,  special, punitive and exemplary damages for injuries that are economic and non-economic.  

There are indications  that plaintiffs in a DePuy Pinnacle lawsuit have a high likelihood of getting a favourable settlement. One such indication can be found in the legal funding industry. Many legal funding companies have provided plaintiffs with non recourse cash gifts in their pending cases. In simple terms, this provides funding for these lawsuits, a financial aid that needs no repayment should the verdict go unfavourable.

Therefore, it is more advantageous  to be forthright in filing a Pinnacle lawsuit against DePuy to avoid losing one’s right to a just compensation. In this regard, the internet has given another distinct advantage, providing quality information and legal expertise in sites like www.rotlaw.com of the Rottenstein Law Group(RLG) for example.

Perhaps Payne is wondering how these things could have happened to her. When upon professional advice, she was promised a solution to her hip problem.