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60_0307_NECCpreview_620x350_620x350.jpg (This photo was taken from CBS.com)

Last night “60 Minutes” did a segment on “Lethal medicine linked to meningitis outbreak.” The New England Compounding Center was producing a steroid that helps to relieve chronic pain in patients’ backs and joints. This steroid has lead to 50 deaths and other significant problems for 700 innocent patients. This is all due to the lack of drug safety. The steroid is contaminated with fungus, which leads to patients contracting meningitis. This meningitis can go to a patient’s bones, nerves and even brain. When the meningitis gets to the brain there is a very low percentage of patients who survive. This lethal medicine has caused many issues for those who have used it; many of these problems cannot be cured and the lives taken cannot be replaced.

The New England Compounding Center in Massachusetts got greedy and “sloppy,” said a former employee who spoke on “60 Minutes.” They were trying to produce mass amounts of drugs while reaping the significant benefits. Therefore, the drug preparation became unsterile. There was mold found in the Clean Room One at the NECC 12 times in three years. A supervisor was warned and according to the employee who was interviewed on “60 Minutes,” the supervisor just shrugged and didn’t say anything about the issue.

According to the “60 Minutes” segment, “the New England Compounding Center was what’s known as a compounding pharmacy. By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market. That would require the oversight of the FDA. Instead, the states are licensing compounding pharmacies to make drugs for individuals. For example, a doctor might order a liquid form of a medication for a patient who can’t swallow a pill. Compounding pharmacies are bound by one rule: they must have a prescription for each individual patient.”

The NECC was shipping tens of thousands steroids out of the Clean Room One. It was stated that the 3,000 clients that NECC sold to were part of the fraud. The Clean Room One was shown on “60 Minutes” for the first time for the public.

There are many concerning issues for patients. One such concern is that there is no cure for those patients who are infected by the fungus. To date, no doctor has said the fungus is completely gone from an infected patient’s body. It is a constant worry and according to patients who are infected, the treatment is very rough. The other concerning issue is that as patients, we do not know what drugs are approved by the Food and Drug Administration. We simply trust the care of the producers to have safety precautions and make drugs properly. Clearly, those producers cannot always be trusted.

It is still unclear on how the drug was contaminated. What we do know is that there is no cure and the consequences are severe. When the FDA went into the NECC for a safety and cleanliness check, they found 50 samples of the medicine and they were all contaminated with fungus. The company is now in bankruptcy and has faced many trials. However, a life of a loved one cannot be replaced. If you or a loved one has experienced a situation similar to this one please give us a call. No one deserves this kind of treatment.

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Wyeth Pharmaceuticals Inc., (now owned by Pfizer) a pharmaceutical company has agreed to pay $490.9 million to resolve the unlawful marketing of the prescription drug Rapamune. The U.S. Food and Drug Administration (FDA) did not approve it as safe and effective, the Justice Department announced the other day. Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ for patients 13 years or older.

The Federal Food, Drug and Cosmetic Act require companies, including Wyeth, to specify the intended use of a product in the new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label uses until the company receives FDA approval for the new intended uses. Rapmune was approved in 1999 for the use of renal (kidney) transplant of patients. However, Wyeth trained its national sales representatives to promote the use of the drug in non-renal transplant patients. The sales representatives were also trained on how to present the materials to physicians who make these transplants. Finally, Wyeth encouraged sales members, through bonuses and financial incentives, to target all transplant patient population to increase Rapamune sales.

Wyeth Pharmaceuticals is merely concerned about the profit the drug can make and not the risks or side effects of the patients. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.

Wyeth has pleaded guilty for misbranding violation under the FDCA. The criminal fine and forfeiture total is $233.5 million. There is also a civil settlement with the federal government and the states that is $257.4 million. Wyeth has agreed to settle its potential civil liability in connection with its off label marketing of Rapamune. The unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label.

The side effects of the unapproved uses include:

1. Peripheral edema (fluid retention in the lower limbs)
2. Stomatitis (inflammation of the mucus of the mouth)
3. Rash
4. Mouth ulceration
5. Elevated lipid concentrations
At times, being a patient is difficult. We trust our doctors, and nurses to do the right thing and provide the right care. The doctors and nurses trust the manufacturing company and pharmaceutical companies to produce the right product. Dishonesty and profit exceeding patient care and safety is occurring more often then not these days. Patients have to deal with the consequences of the unapproved prescription drugs or the product malfunction that therefore leads the patients to have severe side effects. These side effects certainly range from death to a stomach bug, but neither is acceptable or rightly deserved. All patients should be treated with the best care possible. Patients need to be health advocates and make sure what is going into their body is right. It is essential to ask different doctors about drugs and products, do research and constantly read about products. It is easier to be a health advocate then have to deal with the side effects later in life.

If you or a loved one had something like this or similar happen, you can seek justice. Please call for a free consultation. It is important to protect patient safety. Drug companies must only market and promote their drugs for FDA approved uses. The consequences do not exceed the patients life.

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908426_-_im_supportive_-.jpgAs a patient, being a health advocate is important. As our world progresses so does technology and the advancement in the medical field. Companies are making products so quickly, so the product can be sold in stores. Often products have not been tested to ensure the product works correctly. This therefore leads to severe consequences. As patients and citizens we trust doctors and hospitals to care for us in a proper and safe manner. We also trust companies to produce products that are not harmful and work correctly, although more times than not this does not happen. From simple products that you receive from the convenience store to products that could save your life, need to work properly.

Jason Peters, a Philadelphia Eagles left tackle player ruptured his Achilles tendon in March 2012. He was told to use a rolling walker after his surgery on his Achilles tendon. A rolling walker enabled Peters to still be mobile without putting pressure on his Achilles tendon. There are various amounts of rolling walkers, although the one Peters was using was one that he put one knee on while pedaling with the other leg. However, Peters walker broke below the handlebar while he was using it. This failure led to Peters re injuring his Achilles Tendon during the fall which resulted in another surgery on Peters Achilles tendon. The second surgery prevented Peters from returning for the 2012 season. The Roll-A-Bout walker is suppose to hold any person up to 500 pounds. Peters was 340 pounds which does not explain why the walker broke. The malfunction of the walker has not been stated but assumed that the walker was just broken. Peters was awarded $2 million in the lawsuit against the walker company.

Something simple as a walker can cause injuries that could have been prevented. However it is hard to ensure that a walker is working properly because we just assume that things similar to this are in proper condition. However if you or someone you know used a walker, be a health advocate and make sure it assembled properly. It is essential to triple check that all the parts are assembled correctly to prevent casualties from happening.

In addition to making sure walkers are in the best condition before use, as patients it is important to make certain prescribed drugs are suitable for you. One minor mishap could cause severe complications to you or a loved one. As patients we can prevent from horrible medical malpractice, defective medical device or a defective product. It is easy to check to make sure that what you are using is right for you. It is more of a hassle and life threatening to deal with the complications from not being proactive.

If you or a loved on has been hurt in a walker accidents please call for a free consultation. No one deserves to be hurt when it is out of their control.

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GranuFlo and Naturalyte are two dialysis products recalled by the Food and Drug Administration. Fresenius Medical Care, the world’s largest provider of dialysis clinics and products, manufactures both GranuFlo and Naturalyte. The FDA has issued a Class 1 recall – the most urgent type of recall – on both products. This recall is reserved for situations that lead or could possibly lead to death. These two drugs are leading to severe complications and increasing the risk of death.

GranuFlo and Naturalyte are dialysate acid concentrates. These products are used during dialysis, which is the process of mechanically removing toxins from the blood of patients with kidney failure. During dialysis, bicarbonate is administered to neutralize the acidity that naturally builds up in the blood. In addition to the bicarbonate, GranuFlo and Naturalyte neutralize acid in the bloodstream. Many people, including health care professionals, are unaware of the ingredients in these products that convert to bicarbonate in the body. GranuFlo and Naturalyte consist of acetic acid plus acetate. This is what is being converted to bicarbonate by the patients’ livers. This can lead to an increased risk of a bicarbonate overdose, metabolic alkalosis and death.

In November 2011, Fresenius Medical Care sent an internal memo to physicians working in dialysis centers owned by the company. This memo stated potential side effects associated with elevated bicarbonate levels in the blood caused by these products. The memo also included the fact that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with GranuFlo and Naturalyte. FMC’s studies found that patients undergoing dialysis treatments with these products are six times more likely to suffer from a heart attack or sudden cardiac death. The manufacturer of these products did also notify facilities that are not owned by FMC.

On May 25, 2012 the FDA made the following warning about the risk of GranuFlo and Naturalyte:

“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which if not appropriately treated may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

The New York Times
gives more information on the warning.

GranuFlo and Naturalyte side effects include heart attack, low blood pressure, myocardial infarction, stroke, metabolic alkalosis and cardiopulmonary arrest. More information on side effects can be found here. If you or a loved one had GranuFlo or Naturalyte dialysis treatment and are having these side effects, please consult your doctor. It is important to know what is being injected in a patient’s body. Many drugs have side effects, however those associate with GranuFlo and Naturalyte are extremely severe. Everyone deserves justice. Do not let a situation like this go unnoticed.

Please call us for a free consultation.
Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
Toll Free: 866.832.9300
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Intuitive Surgical Inc., maker of the Da Vinci Surgical Robot broke procedures when it warned patients and surgeons about problems with the robot without first alerting regulators. The FDA noted four observations in a Form 483 letter following inspections at Intuitive’s facility.

The Form 483 is a notice that informs a company about possible violation(s) of federal regulations that are found by FDA inspectors. These are inspection observations and do not represent a final determination by the agency regarding compliance.

The FDA noted in its observations that a correction conducted by Intuitive to reduce the health risks posed by its devices was not reported in writing to the agency. According to the FDA, on October 10, 2011 Intuitive notified patients about “suggestions and recommendations for the proper use of instruments with tip coverage and for the correct generators that should be used with mono-polar instruments.” This was not reported to the San Francisco District Recall Coordinator. This notice was in response to the 134 complaints and 82 filed Medical Device Reporting, or MDRs, related to tip cover issues.

On October 13, 2011, the FDA noted that Intuitive sent another letter to da Vinci Surgical Robot clients informing them that the devices were not cleared for thyroidectomy indication. However, the company did not report this to the regulator. The agency noted that Intuitive received 13 complaints and filed five MDRs related to thyroidectomy performed with the devices.

Intuitive sent another letter to da Vinci clients on October 17, 2011 with information on the proper flushing of instruments, the proper transportation of the da Vinci between buildings and inspecting instrument cannulas. This information was also not reported to the San Francisco District Recall Coordinator.

Intuitive also did not report injuries or illnesses that occurred with the use of correctable devices. This includes the five MDRs associated with the action taken on October 13.
In addition, Intuitive did not establish procedures for design changes. They did not document the decision to add thyroidectomy indication to the da Vinci system general laparoscopy clearance. At the time there was no procedure in place to document this, but on April 2, 2012 there was a procedure.

Finally, Intuitive failed to adequately document design input requirements. The intrasurgical cleaning of surgical instruments was not part of the user needs included with the robot. However, the design of surgical instruments is commonly known to need cleaning during surgery.

With all of these observations, the San Francisco District Recall Coordinator was never notified.

These observations are essential for the use of the da Vinci Robot manufactured by Intuitive Surgical, Inc. As patients we trust our physicians to do the right thing. We also trust the companies who produce products to uphold certain standards that keep us safe. When information is not released to the FDA about an issue like this, serious complications arise. If you or a loved one had surgery performed by a da Vinci Robot and may be injured please call us for a free consultation. Justice can be sought and no innocent person deserves to be injured.

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Transvaginal mesh was introduced in the 1990’s to help fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs drop into the vagina. These organs include the bladder, rectum and uterus. Stress urinary incontinence occurs from everyday activities that put pressure on the bladder. Both of these circumstances affect older women who may have received a hysterectomy, gone through menopause, or after childbirth.

The transvaginal mesh is surgically implanted through the vagina to help support the organs. However, as with many technological advances, this breakthrough also came with its share of disadvantages. The transvaginal mesh is associated with many complications. The most common are organ perforation and erosion. Transvaginal mesh erosion, also called mesh extrusion, occurs when the rough edges of the synthetic mesh cut through the vaginal lining and nearby organs. This can cause organ perforation, infection, bleeding, pain during intercourse and urinary problems. The Food and Drug Administration (FDA) noted that there are reports of recurrent prolapses, neuromuscular problems, vaginal scarring and emotional problems as a result of the mesh. Other complications include constipation and urinary incontinence (UI). UI is the involuntary loss of urine usually during pregnancy, after childbirth and menopause.

There have been many issues and complications associated with the FDA concerning the transvaginal mesh. A similar mesh has been used successfully for many years to remove hernias. However, the mesh was never tested by the FDA for use in vaginal repairs. The FDA’s fast-track approval system, called the 510(k), doesn’t require testing prior for a product’s release into the market as long as the product is similar to an already-approved product. In this case, the successful removal of hernias was the similar procedure and thus the mesh was approved.

In addition, after the FDA assessed the mesh further, conclusions were that the mesh does not fix the symptoms of pelvic prolapse or improve the patient’s quality of life more effectively than non-mesh repairs. The FDA also concluded that using the mesh causes more risks than a non-mesh repair would. There is no evidence that mesh used for repairs on the top or back wall of the vagina provide any added benefits compared to traditional surgeries without the mesh. The FDA also found that the mesh can shrink or contract once inside the patient causing pain and tightening. This erosion and contraction can lead to pain during intercourse. It can also cause irritation of the penis when exposed to the mesh. The drugwatch has more information concerning this issue.

American Medical System Inc., unit of Endo Health Solutions agreed to pay $54.5M to settle lawsuits of women who were in pain and left with incontinence after having transvaginal mesh surgically implanted. Officials of the company said in a securities filing that the medical device maker is paying to resolve an unidentified number of suits over the company’s vaginal-mesh devices. These devices include the Perigee, Apogee and Elevate implants.

There are 5,000 vaginal mesh suits that do not affect the settlement of the American Medical System. All 5,000 suits are being consolidated for pre-trial proceeding before a federal judge in West Virginia. The first case is set for December 2013.

If you or a loved one had transvaginal mesh implanted and has experienced complications or pain, please consult your doctor. In addition please call us for a free consultation. It is your right to learn the best treatment possible and your legal options concerning this issue.

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There has been a decent amount of coverage on the prescription drugs Januvia and Byetta. Januvia (sitagliptin) and Byetta are both injectable drugs, and provide a new way of treating type 2 diabetes. They both help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1). They have potential advantages over older medications, said Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles781607_vitamins.jpg.While the benefits of these new methods of treatment are undeniable, a side effect of these drugs is pancreatic cancer.

Every drug has side effects, even aspirin. These side effects are listed on the package insert, and are provided at the drug company’s discretion. As patients, people need to read the package insert and be aware of potential side effects that come with the use of the drugs they may be consuming.

Dr. Mary Ann Banerji, director of the Diabetes Treatment Center at SUNY Health Science Center Brooklyn in New York City, said the concerns about Januvia and Byetta should not be blown out of proportion. Doctors prescribe drugs on an individual basis, because, in the end, all of medicine is individual. Banerji goes on to say that “we should use these drugs judiciously along with metformin” because epidemiological studies have not established a significantly increased risk of pancreatitis associated with Byetta.

For more on the USA Today article please look here.

While all drugs have many side effects, they do not affect all people. In most cases, the benefits of the drugs out weigh the potential side effects. That being said, if you or a loved one may be experiencing side effects while using Januvia or Byetta, stop taking the drug and talk to your doctor.

Technology and medical breakthroughs provide humans with more opportunity to live longer and handle health conditions in a safe and timely manner. The advancement in technology provides great advantages, but there are also many disadvantages. Today, physicians are using robots to do surgery and there are countless prescription drugs to help with health issues ranging from a headache to cancer. Although great things have come from medical discoveries, the large amounts of side effects are one disadvantage of all of the medications that pharmaceutical companies are producing.

Some side effects are unavoidable. However, as patients and consumers of prescription drugs, we need to be aware of the side effects. Reading the package insert, along with the directions for consumption is an essential step for even the simplest drugs. While not all of the side effects are serious nor will they all affect us, it is important to know what you are putting in your body and what the ratio is between the potential benefits and potential side effects.

If you or a loved one has been affected by Januvia, Byetta or any prescription drugs please call us for a free consultation. Even though the side effects are listed on the packaging, justice can still be sought.

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syringe.jpgA pain shot made in a Tennessee pharmacy may be contaminated and could be making people sick. This is very similar to the meningitis outbreak that happened last year. The results of this outbreak are less severe than the outbreak of the meningitis illnesses, but there are infections at the site of where the pain shot was inserted. These infections are skin and soft tissue of unclear etiology following the injection. This is leading to many patients having abscesses. An abscess occurs when white blood cells move through the walls of the blood vessels to the site of infection and collect in the area of damaged tissue. The result of this is the presence of pus. Pus is the buildup of fluid, living and dead white blood cells, dead tissue, and bacteria or other foreign substance. Abscesses can show up anywhere on the body. The most common sites are in your armpits, areas around your anus and vagina, the base of your spine, around a tooth, and in your groin. However if you have received a pain shot, abscesses would form at the site of the shot.

There have been many outbreaks in the past few years, but this particular outbreak comes from contaminated pain shots that were produced by the Main Street Family Pharmacy in Newbern, Tennessee. This shot was sent to patients in 13 states including: Texas, Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Caroline, South Caroline and Tennessee.

Recently, the Food and Drug Administration (FDA) reported that the firm was recalling all amounts of sterile injection drugs. This action was taken in response to seven patients being infected as stated on Vitals on NBC News.

This outbreak is getting so serious that Congress is getting involved. The FDA has asked Congress to pass legislation giving it more power to regulate pharmacies, most importantly large scale pharmacies that ship products in large quantities and across state lines. These shots – along with the subsequent infections – were sent nationwide and crossed state lines, which in itself puts a huge risk on the mass production of the product. As a patient, or if you know someone who was or has been affected by a contaminated shot, write to your congressperson in your state. The more support and cases they are made aware of, the quicker a bill will get passed. This will result in more regulation of the pharmacies, drugs and pharmaceutical companies.

As patients we not only put our lives in the hands of those physicians that are caring for us, but we also have faith in the prescribed drugs that physicians suggest. We have confidence in the pharmaceutical companies and pharmacies in producing prescription drugs that will help patients, not harm them. There are simple steps we as patients can take to ensure we are getting the best care possible. We can make sure our health care providers are wearing gloves, cleaning needles, inserting shots in the correct spot and following up on any procedure. However, it is difficult to ensure the pharmaceutical companies and pharmacies are doing their job correctly. It is important to ask you physician about the drugs they prescribe to you. It is recommended to research the prescribed drug and get as much information about it as possible. While it is hard to have control of the drug itself, we can try to ensure that we as patients are receiving healthy and safe drugs.

If you or a loved on has ever had a case similar or the same to the outbreak of a contaminated shot please feel free to call for a free consultation. These outbreaks have occurred in Texas and you may be affected. Do not let a situation similar to this unnoticed.

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In June 2012, Stryker, a medical technology company, decided to voluntarily recall its Rejuvenate and ABG II modular-neck hip stems. The modular neck-hip stems provide surgeons with the ability to correct certain aspects of a patient’s anatomy and his or her bio-mechanics. However they decided to recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction, which may result in ALTR (adverse local tissue reactions). In addition, possible pain and/or swelling at or around the hip may occur. This is due to metal-on-metal ball-and-socket components. Stryker’s two modular-neck hip stem systems do not consist of metal ball-and-sockets. However since the Stryker necks are made of chromium and cobalt and the stems are coated with titanium, they do have metal-on-metal connection. The friction caused by metal rubbing against metal deposits shards of metallic fragments into a patient’s tissues, bones or bloodstream. This is what causes the fretting, corrosion or swelling.

Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. However, both of the products were submitted under FDA’s 510(k) Premarket Notification Process. The process does not test the product if it is similar to one the FDA has already approved. Thus neither product was tested and both were approved because they were similar to other “sanctioned technologies.”

Approximately 20,000 Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012. Before the recall, Stryker acknowledged that the company was aware of the problems in an Urgent Field Safety notice sent to doctors in April 2012.

Stryker suggests that surgeons consider performing a clinical examination, such as blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling. Physicians should also perform a repeat follow-up examination, such as blood work. Cross section imaging should be considered even in the presence of normal initial findings, according to Stryker.

If you or a loved one is a patient who received Rejuvenate and ABG II modular-neck hip stems frequently asked questions for your physician are crucial in the follow up appointment. In addition Stryker is reimbursing patients for testing, treatment, revision surgery, and other costs relating to this voluntary recall, only if necessary. Questions on claims and reimbursement may assist you further. Stryker is partnering with Broadspire Services, Inc., immediately. This is a third-party claim that will help mange requests for reimbursements of costs relating to the voluntary recall.

If you or a loved one had one of these devices implanted and suffered from complications or side effects, you have the option to seek justice. You are not alone, while 20,000 other patients received the same procedure. Please feel free to give us a call for a free consultation.

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The da Vinci Surgical Robot is a large machine with arms that surgeons use to perform surgeries. A surgeon sits in a console, which gives a 3D view of the surgery while controlling the arms. The surgeries include hysterectomies, prostate removals, gastric bypasses, gall bladder removals and thyroid cancer surgeries. The da Vinci Surgical Robot provides a greater range of motion for the physicians and the ability to perform a more precise surgery. In addition, the robot surgery results to less blood loss, smaller scars and faster recovery.

The da Vinci robot has also surprised Wall Street in “growing sales but also concerns.” The da Vinci Surgical Robot is manufactured and marketed by Intuitive Surgical, Inc. of Sunnyvale, California. Sales of the robot are growing, starting with 40 machines in 2000 and increasing to 2,500 in 2012 and 450,000 surgeries. Hospitals all around the country have this machine and surgeons perform countless surgeries using the robot. It has been marketed as a way to increase their revenue and gain market share. Hospitals and physicians around the country, regardless the cost of $1 million dollars to make and use, have not been deterred and continue to use this product to perform surgeries. Intuitive Surgical Inc. pays for doctors to have a two-day tutorial on the product and ensure doctors are performing the best surgeries possible. Some hospitals continue their own training on the product while other hospitals allow their surgeons to perform surgeries after just two days of training. Many lawsuits have resulted from inexperienced and uneducated physicians using the robot.

Always ensure your surgeon is experienced and well trained. This is one way to prevent from malpractice and complications for you or a loved one.

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is the best source for medical adverse events. Since 2000, the database shows reports of at least 85 deaths and 245 da Vinci-related injuries.

These injuries could result from numerous incidents but one da Vinci lawsuit has resulted from surgical tips (scissors) of the arms that were not insulated. According CNBC, “micro-cracks” in some models of Intuitive Surgical’s monopolar curved scissors can cause leaks that “may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury”. The article goes on to say that “these micro-cracks may not be visible to the user.” Because of these cracks, an electric current jumps from the tip of the arm to healthy internal organs and tissue. It is a spark that is burning the organs and leading to severe injuries and even death.

Da Vinci Surgical Robot injuries include surgical burns to arteries or organs, peritonitis (painful and tender inflammation of the lining of the abdomen), sepsis, excessive bleeding, burning of nearby organs including the intestines, punctured blood vessels, organs or arteries, burns and/or tears of the intestines, bowel injuries, punctured or cut ureters, vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy), additional surgical procedures following robot surgery, swelling of the belly, no appetite, a fever, and wrongful death.

Some critics say Intuitive Surgical Inc. is ignoring the defect of the tip of the arms and care more about profits from the product.

The da Vinci Robot is a groundbreaking invention. It has created better surgeries for surgeons and greater results for patients. However, a defective tip on the product is harming innocent patients, which could lead to serious injuries and even death. Every patient deserves justice. Technology and the advancement of our world should not lead to something worse. This machine was designed to help and improve surgeries, not create more complications.

If you or a loved one has experienced a situation similar to this please give us a call. No one deserves poor medical treatment. We accept all cases regarding defective or unsafe medical device.

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