U.S. District Judge Joseph R. Goodwin recently set a February 5 trial date in West Virginia for the C.R. Bard Avaulta vaginal mesh cases. This trial date covers the first of nearly 600 federal cases against Bard for its vaginal mesh implant. Judge Goodwin is also overseeing trials against Johnson & Johnson, American Medical Systems, and Boston Scientific for failures in their comparable mesh implants.

In July 2011, the FDA issued a universal safety warning against these devices for a high risk of adverse side effects. Over 75,000 women a year have these mesh devices implanted and hundreds, if not thousands, suffer immense pain and have to undergo additional surgeries. The FDA has recently ordered all manufacturers of the vaginal mesh to conduct studies based on the high rates of failure, complications, and organ damage.

The medical device attorneys at Arias Ozzello & Gignac are investigating claims against the manufacturers of the vaginal mesh devices. If you or someone you know has a mesh implant and is experiencing severe pain or has undergone corrective or removal surgeries, contact us today for a free consultation. You may be entitled to compensation for your pain, suffering, and other damages.

In June, the FDA will hold a two-day meeting to evaluate the current standards for metal-on-metal hip replacements. Numerous adverse reports regarding the all-metal hip implants have led to growing concern over these devices specifically, as well as the standards for medical device approval in general. The FDA will be seeking the advice of medical experts, scientists, and researchers to possibly establish new requirements for devices before they can be marketed and sold in the United States. This two-day conference will address numerous concerns over the safety of the all-metal hip implants and the standards for medical devices in general.

Growing safety concerns have already led to a recall of almost 100,000 all-metal hip implants. Numerous lawsuits across the United States have been filed against the main manufacturers of these devices, including Johnson & Johnson, DePuy, and Zimmer, because the all-metal hips have been failing at a premature rate and often cause patients to endure excruciating pain and undergo subsequent surgeries.

The hip replacement attorneys at Arias, Ozzello & Gignac are currently investigating claims against the all-metal hip implants. Contact us today if you have been injured as a result of these defective devices. You may be entitled to compensation for your pain and suffering.

Since 1968, more than 600,000 knee replacement surgeries have been performed to help patients with knee joint damage. Knee joints can be rendered useless by injuries, such as those sustained in certain sports or serious falls, and from the effects of arthritis. Knee replacement surgery has become one of the most common surgeries performed in the United States, and the majority of patients are older people, although the surgery is also common for younger people such as athletes who have severe injuries from sports or car accidents. Overall, knee replacements can give a patient back the ability to walk without pain and engage in exercise and healthy activities that contribute to quality of life.

There are several ways a knee replacement device can be implanted, and the Zimmer Nex-Gen CR-flex knee model was one of the more popular choices of orthopedic surgeons due to its relative ease of implantation. The Zimmer NexGen CR-flex knee replacement model, however, proved to have a very high incidence of failure when compared to other knee replacement options.

According to a 2010 report by a respected orthopedic surgeon, the Zimmer NexGen CR-flex device had too high a failure rate to warrant its continued use. The device was advertised to last at least fifteen years with average use, but the Zimmer NexGen CR-flex device had a life of as little as three years in many patients before serious problems developed. While there has been no Zimmer recall by the Food and Drug Administration at this point, the outcry from certain surgical centers to remove the product from the market continues.

According to one study done at the Rush University Medical Center in Chicago, 36 percent of patients who received the Zimmer NexGen CR-flex suffered from a loosening of the device from the femur, the large thigh bone to which the knee replacement is attached. In at least eight percent of these patients, the pain from the loosened knee replacement was so bad that they were convinced that they needed to undergo a second surgery to correct the problem. The second surgery, known as "revision surgery," has a high rate of success when a different device or knee replacement technique is used. However, the pain of multiple knee replacement surgeries is a deterrent to many patients who may choose to suffer with the Zimmer model rather than undergo revision surgery. Most frightening of all, with no recall of Zimmer knee replacements forthcoming, doctors continue to use the Zimmer devices in alarming numbers.

If you have suffered from side effects including pain, loss of mobility, infections, and failure of knee replacement due to the Zimmer NexGen CR-flex device, it is time to take action. First, talk to your doctor about possible options for repairing your knee replacement. Next, contact a professional Zimmer attorney. A professional injury lawyer can guide you through the steps you need to take to file a suit to recover damages for your injuries from Zimmer products, including medical bills, pain and suffering, loss of work time, and other expenses.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are two very common problems for women, especially those over 40. Childbearing, age, and weight gain can all contribute to the progression of these conditions. Both can be quite embarrassing for women, as the sagging of the pelvic organs and pressure placed on the bladder can lead to “accidents” when a woman laughs, sneezes, or coughs. Both POP and SUI are far more common in older women, but younger women can also suffer from these conditions.

To counteract the problems of POP and SUI, researchers created a device known as the transvaginal mesh treatment, or TVT. TVTs combine tough, durable plastics to create a sling or net that holds up the pelvic organs, releasing the pressure on a woman’s bladder and solving the SUI problem in many cases. At first glance, these devices seemed to be the perfect solution to age- and stress-related urinary incontinence caused by organ prolapse.

However, it soon became apparent that several manufacturers had real problems with TVT devices, and that some of these problems could lead to destructive and health-damaging side effects for the women who had undergone TVT surgery. These problems led to a widespread call for an effective vaginal mesh recall, although the Food and Drug Administration has so far declined to order the recall of these products.

Between 2008 and 2010, almost 3,000 complaints were lodged with the FDA about side effects and problems from TVT procedures. In one clinical trial over 15 percent of the patients in whom TVTs has been implanted suffered severe complications. Some of the most serious complications involved erosion of the mesh into the surrounding organs. Pieces of mesh have been found in the vagina, rectum, and bladder of patients who were given TVTs. The TVT procedure can also lead to severe pain, infection, and most importantly, a recurrence of the original symptoms. Many women who had TVT surgery were forced to undergo a second surgery to repair damage caused by the TVT or to fix the POP or SUI conditions the TVT had failed to solve.

The FDA may not have chosen to recall vaginal mesh products, but it has issued statements saying that the side effects of TVT procedures are "not rare" and that other forms of surgery can provide equal or better benefits to women suffering from POP and SUI. However, it is estimated that in 2011, at least 75,000 women were given TVTs as part of the surgical repair of prolapsed organs.

If you have undergone TVT surgery, it is very important that you contact your medical professional as soon as you experience any side effects at all. TVT complications have a way of growing in severity, so the sooner you catch the problem, the easier it will be to solve. If you have suffered from side effects, it is important to contact an expert personal injury attorney immediately, as well. A faulty vaginal mesh lawyer can examine the facts of your case and advise you on the best way to seek damages for your medical bills and pain and suffering.

ASR stands for "articular surface replacement" and refers to devices used in common hip replacement surgery. An ASR replaces faulty hip joints where the legs connect to the pelvis, allowing patients more mobility and freedom of movement, as well as often relieving the severe pain of degenerative arthritis or fractures in the hip area. Depuy, one of the manufacturers of ASR devices, has been forced to recall many of their ASRs due to high failure levels and other dangerous side effects. The August, 2010, Depuy recall reportedly affected over 90,000 recipients of the company’s ASR devices.

One of the biggest reasons for the recall of Depuy ASRs was the high failure rate. As many as one in eight patients who received a Depuy ASR device during hip replacement surgery required a second surgery to fix problems with the device. Given the high number of older people requiring hip replacement surgery, these numbers are frightening when the statistics of post-surgery medical problems are factored in. More surgeries simply mean more risk for unsuspecting patients beyond the obvious inconvenience, pain, and expense of these procedures.

The Depuy ASR hip replacements have also been tied to other side effects. Patients have reported a high incidence of inflammation due to autoimmune responses from the product. The Depuy ASR is a metal-on-metal hip replacement device, and there have been reports of metal shards working loose and traveling into the hip bone and surrounding muscles and tissues. This can lead to severe complications including infection, loss of mobility, and pain.

Observers and researchers have concluded that one possible reason for this problem is that the materials used in the Depuy ASR hip replacement device do not bond with the hip bone as intended. In these cases, the metal may be compromised and eventually shred due to constant friction with the hip bone. ASR devices can cause the hip to suddenly slip out of place, resulting in dangerous falls and the necessity for further medical treatment. The poorly-working hip joint can also cause excruciating pain and loss of use of the leg, the very symptoms the hip replacement was designed to treat.

Several lawsuits have already been filed against Depuy for the ASR hip replacement devices known to be linked to these side effects. Some of these suits by individuals are already under consideration in the courts; others may be filed as a class action, which means that many defendants band together to concentrate litigation efforts under one group of attorneys.

However, the first step in filing a Depuy hip replacement lawsuit is contacting a professional personal injury lawyer, no matter how your case winds up being filed. A personal injury attorney can give you the facts regarding the Depuy hip replacement lawsuits and can evaluate your case to determine if you have reason to seek damages from the company. A good personal injury attorney will never charge you for a consultation so you can meet with your attorney without risk and find out if you have a case against Depuy for your hip replacement malfunctions or side effects. You may be entitled to damages including medical bills, pain and suffering, and other costs.

Health regulators in Britain have recently increased monitoring for patients who have received metal-on-metal hip replacements. In the past, patients with these hip replacements have been seen by medical providers every 5 years to check for metal debris shedding into the surrounding tissue, but this monitoring period has increased to every year. Premature failure rates and debilitating effects of metallic debris have led health care regulators to be more cautious about the medical devices. These hip implants were also widely used in the United States but the new British regulations do not apply to patients in the US.

Manufacturers of all-metal hip implants, such as DePuy and Zimmer, have come under recent scrutiny for the wide array of failures associated with these devices. Not only have metal hips been shedding debris into surrounding tissue, but they have also been failing at a rate 2 to 3 times higher than other hips made of a combination of metal and plastic. The high rates of failure have often required revision or removal surgeries, procedures that are both expensive and painful.

Contact our hip replacement attorneys today if you or someone you know has experienced complications from metal debris, premature failure, or any other complications from a metal-on-metal hip implant. You may be entitled to compensation for your medical bills or other damages. 

Mirena, a newer form of birth control implanted in a woman’s uterus, has been causing serious side effects in many women. The birth control device, which has to be implanted by a healthcare provider, can lead to both debilitating and life-threatening side effects including inflammation, erosion of adjacent areas, and abscess. The device has also been shown to move throughout the uterus, perforate the uterus, or embed itself within the uterus, requiring a doctor to locate and surgically remove the device, a process that can lead to infertility. Many women have undergone additional surgeries to remove the device, some even requiring hysterectomies. Numerous women across America are looking to file a lawsuit against the manufacturers of this device for the serious and even life-threatening complications resulting from Mirena implantation.

Mirena was approved by the FDA in 2000 for use as a contraceptive. However, the manufacturer of Mirena, Bayer, Inc., has come under scrutiny recently for these adverse side effects. Some are stating that Bayer exaggerated the benefits while downplaying the serious complications or risks associated with the medical device. The FDA issued a warning to Bayer in 2009 discussing the serious complications women have been experiencing following Mirena implantation.

The medical device attorneys at Arias, Ozzello & Gignac are currently investigating claims against the manufacturers of Mirena. If you or someone you know has experienced any serious or life-threatening conditions from Mirena use, contact us today. We offer free legal consultations to help you discuss your options.

In a New York Times report, it was discovered that in August 2009, a year before the artificial hip was recalled, a Vice President of DePuy Orthapedics, a subsidiary of Johnson & Johnson, sent an email to the President of DePuy as well as other executives that discussed how the FDA refused to approve the hip implant. Despite Johnson & Johnson’s knowledge of the lack of FDA approval, they continued marketing the device, maintaining it was still safe to implant. The all-metal hip implants, roughly 93,000 in total, were eventually recalled in 2010, roughly a year later than the initial email was sent.

The email discussed reports from clinical trials that the need for a revision surgery in those patients with the all-metal hip far exceeded those of the control group. It was also mentioned that to gain FDA approval and remedy the problem, DePuy and Johnson & Johnson would need to conduct further studies, possibly taking years to complete. Notifications of premature failure rates came predominantly from the United Kingdom and Australia. In Australia specifically, regulators urged DePuy to take the all-metal hips off the market before the regulators had them removed. The email further discussed that it would be difficult to prove that the all-metal hip was equivalent to, if not better than, other artificial hip replacements on the market.

Other comparable artificial hip implants typically last 15 or more years, but the all-metal hip implant in question was often failing just a few years after implantation. The failures required additional revision surgeries for patients, causing them to incur immense costs and suffer through additional pain. Studies also showed that the all-metal hip implant sometimes sheds metal into a patient’s bloodstream, often leading to further injuries and damages.

The device referred to in the email was only sold and used overseas. However, a companion model manufactured by Johnson & Johnson was used in the United States in roughly 30,000 people. It has been argued that Johnson & Johnson did not commit any illegal acts by not releasing the information in the email, but it may seriously undermine its defense in the thousands of lawsuits already pending against it.

Johnson & Johnson has come under scrutiny yet again for another one of their business failures. The business being monitored this time is Animas, a branch of Johnson & Johnson that manufactures insulin pumps. Animas is at least the seventh Johnson & Johnson business to come under scrutiny, causing J&J to incur enormous fines and lost revenue. The defects in the pumps, specifically the premature rate of failure of a main component, illustrate two main problems but what is even more disturbing is Johnson & Johnson’s lack of a timely report of these occurrences. A J&J spokesperson said that she did not alert the FDA of these events because they were caused by consumers not using the insulin pumps correctly and ignored warnings that certain parts had come loose.

Johnson & Johnson’s insulin pump, roughly the size of a cell phone, injects insulin into a person’s body through a small needle under the skin. It injects this insulin automatically throughout the day and injects additional insulin before meals depending on the amount of carbohydrates consumed. The problems with these devices lie in the premature failure rate of the keypad that determines how much insulin is released into the body. Johnson & Johnson has decided to use a more durable keypad in future products.

What may be worse than premature failure is that J&J failed to report at least three situations in which the insulin pump failed and caused severe injuries. The FDA requires manufacturers to report adverse reactions or instances of failed devices within 30 days but J&J ignored this requirement. It is known that at least three patients were hospitalized for extremely high blood sugar, coma, respiratory failure, and diabetic ketoacidosis, a life-threatening complication due to a lack of insulin. J&J continued to market and sell these insulin pumps without alerting consumers of these very serious failures. 

Recalls of J&J products cost them $900 million in 2010 alone because numerous products can no longer be sold in stores. This $900 million does not cover the costs of factory upgrades or legal expenses. In reference to the defective insulin pumps, federal regulators have warned Johnson & Johnson that it could potentially face further fines as well as injunction and seizure if it does not correct its violations promptly. 

Last week, the New York Times reported that the FDA ordered the manufacturers of surgical mesh used in women to treat urinary incontinence or pelvic organ prolapse to study its risks. This order comes after a recent warning in July about the adverse side effects and severe complications following implantation of the mesh device.

The FDA issued an earlier warning against this device in 2008 but said that complications were rare. Since then, however, it has been discovered through a study of these devices that nearly 15% of the 185,000 women implanted with the surgical mesh have experienced complications such as infection, erosion of the mesh, hardening of the mesh, and numerous other painful complications. This same study yielded results that determined the surgical mesh devices provided no greater benefit than other forms of treatment.

It is unclear, however, whether this order will yield any results or change the design of the device. In May, over 8 months ago, the FDA issued a similar order to the manufacturers of all-metal hip implants. Yet in these past eight months, it has been reported that manufacturers are still discussing the design, not the design defects. Many are hopeful that design studies of the mesh devices will advance much more quickly than the hip studies. Many doctors are prompting for a recall of this device, and maybe the FDA order will be the first step.