Stryker Initially Ignores FDA Warnings, Then Recalls Hip Implants

July 31, 2009

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.

Click here for more info on Styker Hip Implants.

Getting Acquainted with ADD/ADHD

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. For this reason it is important to remain honest and open with your doctor so that he/she can provide you with the best advice possible. Pay close attention to the drug’s effects on the person taking them. It is important to monitor the minor side effects in order to prevent it from becoming a safety risk. Finally, keep open lines of communication among everyone involved, doctors, parents, children, and family members. The more communication there is the better the outcome will be. Always remember that the vast majority of people with these disorders are treated successfully and effective communication is the key to success.

Sun Safety Tips

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:

1. 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.


2. 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.


3. 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.
   
   
4. 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.


5. 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.


6. 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.


7. 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.
   
   
8. Spend time in the shade. You can still enjoy the warm weather and sunshine without being directly exposed to the sun.


9. 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.