Articles Posted in Defective Medical Device

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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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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The medical device manufacturer Intuitive Surgical, Inc. continues to run into legal trouble over their Da Vinci Surgical Robot. An increasing number of injuries connected to this device and questions over Intuitive’s training and credentialing processes have made this product the source of numerous lawsuits.

Intuitive’s surgical robot was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The robot functions similar to a video game; the physician sits several feet away from the patient and uses a small screen and hand and foot pedals to control the robotic arms. According to the Los Angeles Times, use of the Da Vinci robotic surgery “…has quadrupled in the last four years, and the machine now helps with incisions and sutures in 2,000 hospitals around the world.”

Although this medical device has been touted as a great innovation superior to traditional surgery, its risks may outweigh the benefits. Common complications associated with the Da Vinci robot include extreme internal burning in areas surrounding the incision site. Additionally, Reuters reports that nerve damage has increasingly become a problem in these robotic surgeries due to the way the device requires a patient to be placed on the operating table. These “positioning injuries” occur because the patient must lie on a large ramp, with their head closest to the ground, to allow the doctor greater traction. However, sliding can easily occur and the patient can experience pulling on their nerves. Reuters reports a study in which of 334 patients who underwent Intuitive’s robotic surgery, 22 woke up with nerve injuries related to their positioning.

In addition to the danger of severe complications, Bloomberg has recently noted that some of Intuitive’s business operations may also be questionable. According to recent lawsuits, Intuitive has insufficient training regimens available to those who will operate the device. The major problem with Intuitive’s training regimen is the lack of requirement for doctors to practice under the guidance of a physician who is experienced with the surgical robot. In fact, in the attempt to sell his product, one Intuitive salesman reportedly told a hospital that five supervised surgeries is too many, that a doctor may be considered credentialed to use the robot with even less supervision. This salesman’s manager praised him for using this tactic.

According to the San Francisco Chronicle, the FDA recognizes that the alleged problems with the Da Vinci Surgical Robot have led to over 4,600 injuries and at least 80 deaths. Don’t let a defective medical device ruin your life. Profit-driven medical device manufacturers may often mislead the physicians and the public about the real risks and training requirements of their product in order to reach the highest sales margin possible. It is crucial to know the facts of a given procedure, and those facts may not always be easy to find. Borchardt Law Firm is committed to defending the rights of those who may have suffered devastating injuries from defective medical devices.

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DePuy and Stryker are far from the only medical device manufacturers under fire for producing and promoting defective metal-on-metal hip replacement products. Biomet’s M2A-Magnum hip replacement is now the target of increasing litigation claiming the same disastrous consequences that have occurred under DePuy and Stryker systems. According to the Jere Beasley Report, Biomet marketed this product as having “set the standard for performance and design in hip systems” and as “an ultra-high performance metal-on-metal articulation.” Biomet also asserted that the M2A is superior to other hip replacement products because it is subject to lower wear, excellent stability, better range of motion, and superior joint mechanic restoration.

Metal-on-metal hip replacements may actually be much more risky than the traditional polyethylene hip replacement device. Even though metal-on-metal hip replacements are said to last much longer than their polyethylene counterparts, they are prone to an early failure rate that would likely shock most patients. In addition to the risk for early failure, the health consequences of a metal-on-metal hip replacement can be extremely dangerous. Due to the grinding of metal components, metallic debris may be released into the body and cause serious complications. The problems caused by such grinding include the destruction of surrounding tissue and bone, pseudotumors, and metal blood poisoning. Metal blood poisoning is an especially severe effect of the increase of metal ions in the blood and can even lead to death. Generally, once a hip replacement fails, the patient must undergo at least one revision surgery that can be very complex, painful, and may sustain little hope to re-establish pre-surgery quality of life. Ultimately, the proposed advantages of metal-on-metal hip replacements may be inadequate to outweigh the hazards of such extreme complications.

In one recent West Virginia lawsuit, the plaintiff has argued that Biomet was aware of the risks and failure rates of their product without releasing this information to the public. The West Virginia Record reports that at the time of the plaintiff’s original surgery in 2008, there had already been more than 100 reports of adverse events associated with the M2a Magnum filed with the FDA. It is thus argued that Biomet knew that the product was defective. If Biomet was aware of their product’s severe risks and continued to promote the product as safe, effective, and superior to other hip replacement systems, Biomet could certainly be found guilty of misrepresentation.

Don’t let yourself become a victim of metal-on-metal hip replacement complications. When information is withheld from surgeons, doctors, and patients, it can be difficult to be sure that the procedure you undergo poses no serious health risks. If you believe that you have been misled by the Biomet M2A system, or another defective hip replacement device, it is important to know your rights.

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According to the New York Times, a jury in New Jersey has recently awarded a plaintiff over 3 million dollars in compensation for her pain and suffering after being implanted with Johnson & Johnson’s Gynecare Prolift transvaginal mesh device. Shortly after surgery, the plaintiff became plagued with constant pain, trouble sitting, and painful intercourse resulting from the mesh eroding through her organ walls. She then underwent 18 revision surgeries, all of which failed to effectively remove the mesh and restore her previous quality of life. The San Francisco Chronicle reports that Johnson & Johnson may face additional charges up to $16.75 million in punitive damages. The manufacturer was charged with failing to warn the plaintiff’s surgeon of potential risks and for fraudulently misrepresenting the product.

Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. The mesh sling is not an entirely new concept – it has been used with some success in surgeries in other areas of the body. However, this procedure has proven especially problematic in the female pelvic region due to the increased number of organs involved, the very small area, and possibility of erosion from movement.
Surgeries involving transvaginal mesh have proven the risk for disastrous consequences. Some side effects include organ perforation, extreme pain, infection, bleeding, urinary problems, mesh contraction and mesh erosion through the vagina. After such complications ensue, multiple surgeries are often required to remove the device and reconstruct any damage it caused. A patient may suffer for years after their original surgery from debilitating pain and discomfort. The Houston Chronicle notes that hundreds of thousands of women have had transvaginal mesh devices implanted.

Johnson & Johnson currently faces an estimated 4,000 transvaginal mesh lawsuits, according to Drugwatch. However, Johnson & Johnson is not the only manufacturer facing defective medical device charges for their transvaginal mesh products. Last August, a California jury awarded a plaintiff $5.5 million in a case against medical device producer C.R. Bard.

What’s the take-home message? Even though the New Jersey plaintiff who was awarded 3 million dollars was a nurse, had her surgeon’s confidence, and read a company brochure on the procedure, she still fell victim to a defective medical device. Don’t suffer for years as a result of transvaginal mesh. If you believe you have been adversely affected by this product, contact a lawyer and find out what compensation you may be entitled to.

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The FDA has recently issued an urgent recall on DePuy Orthopaedics’ LPS Diaphyseal Sleeve product. The Class I recall used in this case is the most serious recall status; it denotes that there is a realistic risk of serious adverse health effects or even death. DePuy is still in the midst of defending itself against thousands of lawsuits on their metal-on-metal hip replacement devices.

The FDA defines the LPS Diaphyseal Sleeve as an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. According to DePuy, the LPS system is intended to replace “the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia.” The diaphyseal sleeve component is utilized when patients experience bone loss or defects related to the removal of bone tumors, trauma, infection or difficult reconstruction.

This product carries the risk of failure when the device cannot support sufficient weight. Even normal daily functions can cause the sleeve to fail. The San Francisco Chronicle notes that, in case of failure, the sleeve can potentially fracture. This may lead to loss of function or loss of limb, infection, compromised soft tissue or death. Some more common complications that can occur when implanted with this device include component shifting, loosening, bending, cracking, fracture, deformation or wear of components, fatigue fractions, tissue reaction to wear debris, pain, dislocation, and decreased range of motion.

The FDA has received 10 reports of the device malfunctioning. Of these, 6 patients reported fracturing and 4 complain of painful loosening of the product. The Legal Examiner reports that the affected devices were manufactured from 2008 to July 20, 2012. If you believe you may have been implanted with one of these defective medical devices, don’t hesitate to contact your doctor and find out the risks to your health it may have caused.

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