Hip replacement surgery itself is a painful, time-consuming process. The decision to undergo this surgery is not an easy one. The procedure usually requires months of recovery time in order for a patient to return to normal activities. Patients who have made this difficult decision have relied both on the hip replacement devices that will become a part of their body and on their physicians’ discretion. Patients often have supposed that, although the hip replacement process will be painful at first, in the long run, will make them better off. Despite many individual’s reasonable belief that hip replacement surgery is the best decision, disturbing reports recently have emerged, indicating that a specific type of hip replacement system may be unsafe. These reports indicate that several individuals who have had defective hip replacement devices implanted during their surgery will now have to undergo additional surgeries in order to correct the dangers arising from the defective devices, manufactured by DePuy Orthopaedics. Total hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. This joint replacement orthopaedic surgery is performed for various reasons, including hip fracture treatment, or to reduce arthritis pain. The DePuy ASR hip replacement system has been identified as posing serious risks to implant recipients, including hip failure and dispersal of metallic debris in patients’ bodies. About 93,000 people worldwide have used the devices that are now being recalled because of their high failure rate and, in consequence, the need for repeat corrective surgeries. Following DePuy Orthopaedics’ (a subsidiary of Johnson and Johnson) market withdrawal of the DePuy ASR hip replacement system, and warning to clinicians concerning failure rate information, the U.S. Food and Drug Administration (FDA) has designated the manufacturer’s actions as a Class 2 medical implant recall. The DePuy ASR is a metal-on-metal hip replacement system. Metal-on-metal hip implants increasingly have been associated with various health risks because they are known to disperse metal particles into the body. This shedding of particles can cause tissue damage and deterioration, inflammatory reactions, and can lead to bone loss. Studies have shown that approximately 12 to 13 percent of patients that have undergone hip replacement surgery with DePuy devices will need corrective or replacement surgery within five years to remedy dangers caused by the metal debris. DePuy should be reprehended with regard to its actions and irresponsible conduct in this matter. In fact, DePuy had tried to downplay the seriousness of the dangers associated with its devices by initially indicating that the market withdrawal of its products was due to slow sales rates, rather than critical safety issues. The FDA needs to take more action to ensure that large manufacturers, like DePuy, cannot misrepresent the safety of their products at the expense of a consumer who lacks certain vital informational channels. DePuy should have taken responsibility for its products’ failure early on, rather than misleading the public. Until the FDA betters its process for review of medical manufacture’s devices, and until large manufacturers are reprimanded for their irresponsibility, the average consumer will continue to suffer.

Read More

On November 28, 2007, Stryker Corp., one of the world’s leading manufacturers of hip and other joint replacements was given a warning from the Food and Drug Administration (FDA) regarding their manufacturing facility in Mahwah, New Jersey. According to the letter, the FDA conducted an inspection of the facility and found substandard conditions. This marked the second time that the company had been warned about deplorable conditions in their plants. Stryker in a response letter stated that they did not believe that these conditions posed a threat to patients. The FDA further told Stryker that they had received a number of complaints from patients regarding hip replacement components manufactured at the New Jersey facility. The patients cited implants that did not fit properly leading to problems including pain, difficulty walking, and “squeaky” joints. Others reported that parts of the implant broke off or had been wearing unevenly. Contrary to Stryker’s statements, the FDA letter said that the deficiencies found at the New Jersey plant directly contributed to these defects. The letter also states that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” Finally, after numerous warnings and numerous complaints from patients, on January 22, 2008, Stryker recalled two hip implant components made under the company’s Trident line. The recall, surprisingly, was announced in the same letter used to rebut the FDA’s allegations of deplorable conditions at the New Jersey plant. The recall included the Trident Acetabular PSL Cup and the Trident Hemispherical Cups. Stryker says that the recall was implemented amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceeded company standards. It is clear that Stryker Corp. had no intention to take the FDA’s warnings seriously. Their failures allowed defective products to be manufactured and these products have caused patients to be injured. How many warnings are required before the FDA steps in and takes action to remove not only defective products from the market, but also rogue companies who think that they make their own rules? A few too many.

Read More

By now most people are aware that the high rate of unemployment, resulting from a struggling economy, has put pressure on this nation’s disability insurance system. Adding to the strain of quickly diminishing disability insurance funds is the aging baby boom population. The Social Security Administration has found itself left flooded with applications for disability insurance benefits. As a result of these various factors, the Social Security program has become backed up. Consequentially, it can take years for many individuals who are entitled to disability insurance benefits to receive them. Each year, although about 2.5 million Americans file claims for Social Security disability benefits, two thirds of them are turned down in the first stage of consideration. Numerous applicants then become discouraged and give up pursuing, through appeals, the benefits that they likely are entitled to. A backlogged system due to employee layoffs, high turnover, and arbitrary decisions of employees who deal with such claims is not a sufficient excuse justifying Social Security denials to those who are in need of benefits. Additionally, any Social Security program problems that exist federally should not be passed of to the states; rather, the whole system ought to run smoothly. Legitimate applicants deserve the rightful benefits due to them from the Social Security program, which was introduced by President Roosevelt around time of the Great Depression. Social Security Disability is an insurance program for workers who are injured or ill and as a result of their disability can no longer work. An “insured” worker has worked about 5 years of the last 10 years and has worked a required number of quarters in a year. The Social Security Administration runs two programs for Social Security disability. The first program is called Social Security Disability Insurance (SSDI) or Social Security Disability Insurance Benefits (DIB). The second program is Supplemental Security Income (SSI). For both programs, the Social Security Administration defines “disability” as a physical or mental impairment, which keeps a person from doing substantial work and the impairment is expected to last more than a year or result in death. In determining if a person is disabled, the Social Security Administration looks at their age, education, work history and the transferability of their work skills (can they work at another job). The same definition of disability is applicable to both programs. However, since many factors are evaluated, no two cases are the same. Each case is examined on an individual basis. You do not need to be totally disabled in order to qualify for benefits. The Social Security Administration has listings to describe the severity of a disease or impairment for it to be considered disabling. However, even if you do not meet the listing requirements, it is still possible for you to be considered disabled when looking at your other individual factors. The Social Security Administration should stop using claims increases or organizational troubles as an excuse for denying Social Security benefits to individuals who rightly deserve them. If organizational issues exist within the Social Security Administration and are acting to hinder the Social Security program from providing benefits to those too injured or ill to work, as it was designed to do, the system should be improved. Those who are disabled and unable to work should not have to suffer as a result of the government’s inadequacies.

Read More

Veterans in the United States have worked hard to keep this country safe and secure. They have headed off to fight numerous causes, typically leaving their families behind, in order to ensure the safety of their country. Unfortunately, the government has oftentimes failed to provide adequate medical care to these military veterans who have dedicated several years of their lives to service. Excuses about the shortcomings of veterans’ benefits plans have been plentiful. The government may claim that staffing shortages are the cause of inadequate medical services, or that high volumes of patients and excessive paperwork have contributed to the lack of treatment provided. Disability benefits are available to veterans if they sustain an injury or disease that occurred while on active duty. Often, veterans suffer from a variety of physical and mental health problems. A few of the conditions that veterans may suffer include traumatic brain injuries, severe burns, back pain, and exposure to toxic chemicals. Other heath problems which veterans may face include spinal cord injuries/back problems, cancer, diabetes, depression, post traumatic stress disorder, and various other injuries and illnesses. A disabled veteran may be denied benefits for several reasons. One of the most common grounds for a benefit denial is controversy over whether the health impairment arose as a result of service, or arose from a secondary, non-service related incident. This is a typical obstacle for many veterans, particularly when they experience mental health problems relating to their service, such as post-traumatic stress disorder (PTSD). The men and women who have fought for this country have earned the right to certain benefits and should not be burdened with the impossible task of trying to prove that they lived through trauma in order to get the treatment they are entitled to. Some veterans have claimed that the VA medical staff, as Veterans of Foreign Wars spokesman Joe Davis has said, “are understaffed and over-tasked.” The inadequate medical service provided to veterans has actually prevented some veterans from seeking out treatment. A 2008 Rand Corp. study found that nearly 20 percent of service members returning from Iraq and Afghanistan, about 300,000 people, reported symptoms of PTSD or major depression, but only about half sought treatment. Veterans should not have to jump through hoops in order to obtain the medical services and treatment that they are owed. It should be far easier for veterans to document their disorders and get the treatment they are entitled to and the disability benefits that they need. Disabled veterans, their spouses, and their families should have numerous benefits available to them. Veterans have dedicated their lives to service, protecting others and defending this country’s freedoms, and have incurred wounds while doing so. The government should give them the benefits they are owed.

Read More

Everyone knows that parents these days are constantly being bombarded with warnings about new drugs or diseases or disorders to keep an eye out for. One of the most talked about of these disorders in recent years is undoubtedly Attention Deficit Disorder (ADD) or Attention-Deficit/Hyperactivity Disorder (ADHD). I am sure that every parent has had a discussion with his or her child’s pediatrician about ADD/ADHD. Children all around the country are being diagnosed with this disorder and being treated with drugs such as Ritalin, Adderall, and Dexedrine. The number of children and adults being diagnosed with these disorders is so staggering that these medications have become household names. So, what are ADD/ADHD all about? How are they treated? How do I know whether or not my child or I have the disorder? These are among some of the questions we’ll tackle today. NOTE: We are not doctors by any means and this information should not be used as a substitute for a legitimate medial opinion. This information is meant only to be informational. What is ADD/ADHD? ADD/ADHD is most common in children and teens, but adults can have it as well. The symptoms may vary in each person, and especially between children and adults. Some of the most common symptoms in children and teens include inattention, hyperactivity and impulsivity. Inattention in most children is noticed first in the school environment. Teachers, parents, and most importantly, the student themselves, often notice difficulty paying attention, making careless errors on schoolwork, being easily distracted, inability to concentrate on conversations, tasks, etc. Hyperactivity is another one of the symptoms of ADHD. Hyperactivity usually manifests itself in various forms and generally before the age of seven. Some examples of hyperactive behavior include fidgeting, squirming, restlessness in teens and climbing all over furniture in young children, always wanting to be busy, etc. The symptoms of hyperactivity vary with age and setting so it is important to note the age and setting of the alleged hyperactive conduct. Impulsivity is yet another of the most common symptoms of ADHD. Impulsivity includes actions such as impatience, blurting out answers before questions are completed, and interrupting conversations as well as initiating them at inappropriate times. How is ADD diagnosed? The first and most important step toward a correct diagnosis of ADD is to seek a medical opinion from a licensed psychiatrist. A psychiatrist is trained in various areas including behavioral issues and would be the most knowledgeable resource for a concerned parent or loved one. Although primary care physicians (PCP) are very knowledgeable, they are not specifically trained in this area and it is highly recommended that you see a psychiatrist to diagnose and treat possible ADD. It is also important to mention that because a PCP is often times not familiar with the disorder he/she may experience difficulty in prescribing the correct dosages. The next step is to monitor your child’s behavior. In order to obtain a diagnosis of ADD, the person must demonstrate the three symptoms listed above in more than one setting. The symptoms can be demonstrated at home and school, home and work, school and work, etc. There must also be evidence that the symptoms interfere with the person’s ability to function in some specific setting. Finally, it must be demonstrated that these are long-term behaviors, generally occurring for at least six months. In sum, it is imperative that the person’s behavior be monitored in more than one setting, that the symptoms are long term, and that the diagnosis is obtained from a licensed psychiatric professional specializing in behavior disorders. How is ADD Treated? The good thing about ADD/ADHD is that it is treatable. The most common treatments are drugs classified as stimulants, i.e. Ritalin, Adderall, and Dexedrine. It is believed that these drugs are effective treatments for ADD because they increase dopamine levels in one’s brain. Dopamine is a neurotransmitter that is most frequently associated with motivation, pleasure, attention, and movement. By increasing the levels of dopamine in the brain, it is believed that the drugs boost concentration, decrease hyperactive behavior, and decrease impulsive behaviors. There are a number of side effects that are associated with these stimulant treatments including restlessness, increased irritability, depression, racing heartbeat and various others. The U.S. Food and Drug Administration (FDA) recently warned consumers and doctors that there was a study done that showed an increased risk of sudden death in children due to heart problems associated with ADHD treatments. A later article by the FDA admitted that there were limitations to the study that made it difficult to draw such conclusions from the earlier study. Nonetheless, the FDA highly recommends that anyone who has been diagnosed with ADD/ADHD have a thorough heart examination before being prescribed Ritalin, Adderall or Dexedrine. In addition to the stimulant drugs, ADD can be treated with non-stimulants including the prescription drug Strattera. Strattera, being an anti-depressant has some benefits, especially for those who also suffer from depression and anxiety. Strattera is not quite as effective as the stimulant drugs in treating the symptoms of hyperactivity, however. Strattera is not without its safety risks. The FDA has confirmed that Strattera has been known to increase suicidal thoughts in some teens. It is important to monitor your child’s behavior when taking these drugs and to notify your physician if there are any odd changes in behavior or if the child complains of things such as shortness of breath, increased heart rate, suppression of appetite, etc. Some Final Thoughts In order to maximize the effectiveness of your ADD/ADHD treatment it is important to be informed about the disorder as well as the treatments and their side effects. It is important to know about the medication that you or your child are taking, including correct dosage, possible side effects, and other things to avoid while taking the drug- such as over-the-counter cold medications. It is also important to be patient, finding the correct drug and dosage can be a long process because it is mostly trial and error....

Read More

Summer is just around the corner and many of us are excited about the warm weather and sunshine. Because of the long winters and great local beaches, most New Englanders look forward to spending time outdoors in the sunshine. However, without adequate protection, the sun can be very dangerous. Skin cancers, such as melanoma, are a huge concern. According to the Centers for Disease Control and Prevention (CDC) there are 47,000 new cases of melanoma each year. But, melanoma causes 79% of skin cancer deaths. These sobering statistics emphasize the importance of protecting yourself while still enjoying the sun. Some sun safety tips are: Always wear sunscreen. You should always wear sunscreen, even on cloudy days. It is important that it have an SPF of 15 or higher. Put on sunscreen at least 30 minutes before you plan to be in the sun; this allows time for the sunscreen to be absorbed into your skin. Sunscreen needs to be reapplied every two hours. Re-apply sunscreen. Sunscreen must be reapplied throughout the day. It is very important to reapply after sweating, swimming or drying off with a towel. All of these activities actually wipe off the sunscreen you have applied. Check the expiration dates. Sunscreen can expire and usually products have a listed expiration date. If there is not a date listed, you can use the sunscreen for 3 years. The U.S. Food & Drug Administration requires a 3-year effectiveness for sunscreen. Avoid the sun during the middle of the day. The atmosphere does not absorb as many harmful UV rays during the middle of the day. That is way it is important to avoid the sun between 10a.m. and 4 p.m. Wear sunglasses and protective clothing. Sunglasses help to shield your eyes from the direct sunlight. A wide-brimmed hat is a great way to protect your face from exposure to sunlight. Avoid tanning. Having a tan, may look good now, but in the future can lead to wrinkles and age spots. There is not any safe way to tan. A tan is actually your body’s way of telling you the sun has injured your skin. Be careful of tanning products. If you must tan, be aware of the products you are using. Not all tanning products contain sunscreen. Make sure to check the label. The U.S. Food & Drug Administration (FDA) requires a warning on tanning products that do not contain sunscreen or protect against sunburn. Spend time in the shade. You can still enjoy the warm weather and sunshine without being directly exposed to the sun. Carefully monitor your skin. If you notice any growths, bleeding or changes to your skin, it may be early signs of skin cancer. Skin cancer is highly treatable if caught early.

Read More

On April 22, 2009, the U.S. Consumer Product Safety Commission (CPSC) issued two recalls involving outdoor activities, playground equipment and bicycles. The playground equipment was recalled because lead paint, while the bicycles were recalled because of defective parts. The playground equipment was manufactured in Turkey, but it was distributed in the U.S. by SportsPlay Equipment Inc. The recalled equipment was sold nationwide, from January 2003 to December 2007. The equipment was recalled because it contained high levels of lead paint. Specifically the handrails and posts on the playgrounds had very high levels of lead. The lead paint on the equipment violates the lead paint ban. The new lead paint ban was passed last year in Congress. The ban was passed in response to the problems with Chinese toys and lead. There are new lead standards in place. Children’s products, such as playground equipment, are not supposed to contain any lead. According to the CPSC, consumers should immediately stop using the recalled equipment. Owners of the playground equipment should call the CPSC to receive free replacement parts. There were many types of models are equipment recalled. The complete list can be found on the CPSC’s website. It is very important that consumers stop using the playground equipment immediately, especially children. Children are at an increased risk of developing lead poisoning if they ingest chipping lead paint. Lead poisoning is very dangerous to children and can lead to learning problems, behavioral problems, slowed growth, mental retardation and brain damage. The other recall focused upon bicycles. The recalled bicycles were manufactured in Taiwan and sold in the U.S. by Specialized Bicycle Components Inc. They were sold throughout the U.S. from September 2003 to August 2004. It is the parts of the bicycle that are defected and the reason for the recall. The cable stop on the bicycle frame can loosen. When the cable loosens, the bicycle rider can lose control of the bike and fall off. There have been reports of two falls by riders. Both falls were serious, as the riders suffered fractures, which required surgery and other medical attention. Only bicycles with a single rivet attaching the cable stop to the bike frame are recalled. Other bicycles with two rivets are not included in the recall. The CPSC advises consumers to stop using the bicycles immediately. Bike owners should return the bicycles to Specialized Bicycle Competent Inc. The bicycle will then receive free repairs. More information about both recalls can be found on the CPSC’s website.

Read More

Beginning on February 10, 2009, the U.S. Consumer Product Safety Commission (CPSC) issued new requirements for child products. The guidelines are necessary in order to comply with the New Child Safety Law. The guidelines apply to children’s toys, childcare articles and consumer products intended for children. The new guidelines apply to phthalate and lead levels. Phthalates are chemicals used to make vinyl and plastics soft and flexible. It is because of these qualities, that phthalates are used to make toys. The new phthalate requirements apply to six different types of phthalates (DEHP, DBP, BBP, DINP, DIDP and DnOP). Children’s toys and childcare articles cannot contain any more than 0.1% of any of these six phthalates. According to the CPSC, a children’s toy is defined as “a product intended for a child 12 years or younger to use when playing.” However, bigger items, such as bikes, playground equipment and musical instruments are exempt. Childcare articles are defined as products that a child three years and younger would use for sleeping (ex: blanket), feeding (ex: cup), teething (ex: teething ring) and sucking (ex: pacifier). As a result of the new requirements, companies have a reporting obligation under federal law. Companies must tell the CPSC if they know of any toy or childcare article that exceeds the new phthalate requirements. The new requirements also apply to all toys and childcare articles regardless of when they were manufactured, meaning these new requirements apply to toys currently on the market, not just those made after February 10th. Also beginning on February 10th new lead guidelines will be implemented. The guidelines apply to consumer products intended for children who are twelve years or younger. Lead is often found in the paint of children’s toys. None of the consumer products for children can have more than 600 parts per million of lead. However, these new guidelines do not apply to all products. The CPSC will issue alternative lead limits for some electronic devices. In addition, on January 30, 2009, the CPSC approved a one-year stay on the enforcement of testing for these new guidelines. Manufacturers and importers do not have to comply with certain certification and testing requirements on their products for another year. Manufacturers will not be required to complete testing, but they will still be required to meet lead and phthalate limits along with other mandatory toy standards. Testing is required for painted products and in the future it will be required for metal jewelry. Companies still have a reporting obligation to inform the CPSC if they learn of any products for children, which exceed the lead limits.

Read More

On February 12, 2009, a special court ruled that vaccines do not cause autism in children. The court began hearing three types of autism related cases in 2007. The ruling today concerned only one type of cases, the allegation that autism was caused by the Measles, Mumps and Rubella (MMR) vaccine and other vaccines containing thimerosal, which contains mercury. With these types of cases, the court found there was no association or causal link between vaccines and autism. The court has yet to rule on the other two types of cases: autism caused by the MMR vaccine alone and autism called by thimerosal containing vaccines alone. The parents of autistic children filed petitions with the Vaccine Injury Compensation Program (VICP) seeking compensation, which led to the special court hearing. Understandably, both the medical and scientific communities are anxious to find what exactly causes autism. Autism is a very complicated developmental and neurological disorder. Autism affects the brain, which leads to abnormal communication skills and social interactions. Autism is one of five disorders, collectively called PDD (pervasive developmental disorders). The other disorders include Asperger’s, Childhood Disintegrative Disorder (CDD) and Rett’s Disorder. Autism is the most common PDD disorder and affects roughly 1.5 million people. According to recent statistics, the number of people with some form of autism is rising. In Rhode Island public school’s the number of autistic children increased by 1,500 from 1992 to 2002. Current statistics from the Centers for Disease Control and Prevention found that 1 out of 150 babies are born with some form of autism. In addition, the rate of autism is much higher for males, than females. Boys are four times more likely to be autistic than girls. The debate over the cause of autism has been raging for some time. There is not any single known cause of autism. Potential causes suggested by scientists, medical professionals and parents include genetics, medical problems, pregnancy problems, environmental factors and toxins and vaccines. There is a lack of consensus among scientists and medical professionals as to the potential causes of autism. Although the special court determined vaccines do not cause autism, it is unclear whether others will agree with their decision.

Read More

Peanut Corporation of America (PCA) is expanding the scope of its peanut butter and peanut products recall. Their recall initially included products produced at its Blakely, Georgia plant since August 1, 2008. Now the recall is for all products produced at the Georgia plant since January 1, 2007. PCA is recalling two years worth of peanuts and peanut products. The number of recalled products has also expanded to include all peanuts (dry and oil roasted), granulated peanuts, peanut meal, peanut butter and peanut paste. Pet food is also included in this new expanded recall. Some of PCA’s peanut products are used in the manufacturing of pet food. These additional recalls are all the result of a salmonella outbreak, that PCA KNEW about and did NOTHING to prevent. Over 500 people have fallen ill from salmonella caused by tainted PCA products. Eight people have died as a result. Salmonella is a very serious infection and it can be fatal. Even pet food infected with salmonella can be dangerous if people do not thoroughly wash their hands after handling pet treats. Pets can also suffer from salmonella infections caused by contaminated pet food. The worst part about all of this is PCA knew about the risk of salmonella. According to the U.S. Food & Drug Administration (FDA), PCA’s own tests found strains of salmonella 12 different times in 2007 and 2008 at their Georgia plant. PCA failed to properly respond to the discovery of salmonella. Instead PCA “lab shopped,” meaning it had the infected products re-tested at a different lab. The second test found the products were negative for salmonella and then the company shipped them out. PCA knew salmonella contaminated these products and yet they did nothing. Proper procedure dictates once salmonella is discovered, the entire lot is supposed to be destroyed, not shipped out for consumption. In addition, PCA never took any steps to clean their facility or other measure to prevent cross-contamination once they discovered the salmonella. These problems have been ongoing at PCA and STILL were not rectified when the FDA inspected the Georgia plant in the month of January. According to the FDA testing, it found salmonella in peanut butter paste, peanut meal, peanut butter, peanut granules and oil-roasted, salted peanuts. But salmonella was not the only problems found at PCA’s plant. The FDA also found roaches near the production and packaging areas. PCA’s ventilation system was also inadequate to prevent salmonella contamination in other parts of the plant. PCA’s actions are deplorable. They knew about the salmonella contamination of their products but sent them to consumers anyway. Because of PCA, eight people have died and over 500 have gotten sick. These numbers will rise as more products get recalled. The FDA is still investigating PCA and more horror stories are likely to appear. Click here for more info.

Read More