News & Information

The Food and Drug Administration is debating whether to toughen warnings on tanning beds because of a suspicion they lead to cancer. The pitch for tanning beds has been that they are safer than lying in the sun and do not lead to cancer, but there is an increasing scientific consensus that there is no such thing as a safe tan, no matter what the source.

That is the message that one 18-year-old female received. She was preparing for the Miss Indiana pageant and getting a tan in a tanning salon when she discovered a growth on her leg. It turned out to be an early-stage melanoma, the most danger form of skin cancer. The woman had regularly gone to the tanning beds. It started in sixth-grade when she was a cheerleader. She even owned a tanning bed at one time. No more. She didn’t think the warning label on the tanning bed was meant for her. After all, it was so small, she said, “Nothing to make me stop and think, ‘This is real.’ The melanoma was caught before it spread further.

The World Health Organization has listed tanning beds as a definitive cancer-causer right alongside ultraviolet radiation. Both the sun and the tanning beds emit that form of radiation. Previously it was considered a “probable” carcinogen. The FDA recently decided those small warnings are not strong enough and do not convey the full message. So in March, an FDA advisory panel began public hearings to explore stricter regulations. UV radiation is also linked to basal and squamous cell carcinomas, which affect more than one million Americans a year and kill about 2,000 annually, while melanoma kills about 8,650 annually.

Source Article: http://cbs2.com/health/fda.tanning.beds.2.1433848.html

With the news that full-body scanners maybe coming soon to an airport near you, many are wondering if the scanners are safe. The scanners are designed to find weapons or materials, including plastics and powders that may be strapped to the body that a metal detector cannot find.

The controversy is that the scanners use radiation, a millimeter wave technology, while other scanners being installed in U.S. airports use backscatter technology. With the millimeter wave scanner, extremely high-frequency radio waves pass over the body and the energy reflected off the body generates a three-dimensional image.

L-3 Communications, the makers of one of the devices says the scanners are safe because they use non-ionizing radiation, the same emitted by X-rays and the ultraviolet light of the sun. That form of radiation, with prolonged exposure, can disrupt DNA and cause tissue damage.

But everyday exposure emits the smallest amount of energy, even lower than your cellphone or TV remote. So even if the scanners are safe, some worry about the cumulative effects of the scanners, especially for those who fly often. They are already being exposed to cosmic radiation when flying 40,000 feet.

With 40 machines currently being used at 19 airports domestically and an additional 300 machines in use at U.S. airports by 2011, the National Council on Radiation Protection and Measurements, reports there are several groups of individuals who are significantly more sensitive to ionizing radiation than the average person and may need special consideration.

They include infants and children, individuals with genetically based hypersensitivity to ionizing radiation, and the developing embryo or fetus in a pregnant woman. Three to five percent of the population may be more sensitive to ionizing radiation. #

An Ohio couple says they hope their tragedy will be a lesson to others. Their 13-month old boy is dead after he swallowed a watch battery.

Everyone who has raised children knows they are extremely curious and try to experience the world through their mouth. That means they put everything they pick up in their mouth. Apparently the toddler, Aidan Truett, swallowed a watch battery. His parents knew there was something wrong when the child began having trouble eating.

The small button batteries are used in household items such as watches, DVD remotes and even musical greeting cards. The combination of the current and acid caused severe bleeding that eventually led to the boy’s death. The parents applied CPR but the boy did not respond.

They just hope their tragedy can be a lesson for someone else. The Truitts recommend you write down the size of the batteries you need to replace rather than keep one to take to the store for a replacement. They also want the battery makers to add a protective coating that would prevent them from hurting a child if they are swallowed.

Our condolences and prayers go out to this family for their loss.

Source Article: http://www.news4jax.com/news/22225103/detail.html

The problems that lead to Toyota recalls may prompt Congress to strengthen oversight over the auto industry. Rep. Henry Waxman, who chairs the House Energy and Commerce Committee said that ultimately he believes additional legislation will be needed to strengthen the National Highway Traffic Safety Administration, or NHTSA. The agency may be working in the mechanical age, while cars have today moved into the computer age he says and many regulators at NHTSA lack the necessary skills to critically challenge Toyota’s insistence that it has no problem. In fact, a review of NHTSA has uncovered that there are no electrical or software engineers on staff.

The NHTSA staff is relatively small for the 100 safety investigations it launches every year and 30,000 complaints it takes in. When there is a problem, the agency nudges auto makers into voluntary recalls rather than forcing them. Over the past three years, NHTSA has led 524 recalls involving 23.5 million vehicles. Waxman’s committee criticized NHTSA and its handling of those consumer complaints over Toyota and Lexus cars and their problems with sudden acceleration and brakes that don’t work.

Source Article: http://www.reuters.com/article/idUSTRE61M6NC20100224?type=politicsNews

One of the big cries in health care reform is the need to have our medical information transferred to an electronic data base. The theory is that is patient records are accessible immediately and there will be fewer mix-ups in an emergency and during routine medical treatment. The government is so convinced this is a good idea that it plans to spend up to $27 billion on electronic medical records systems, also called health information technology, or HIT. Every American is supposed to have an electronic medical trail by 2014. But there are problems. Over the last two years, six patients have reportedly died and several were injured when the system malfunctioned. Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health testified at a government hearing on February 18 that there have been malfunctions of the system. HIT has mixed up patients, put test results in the wrong file, and lost medical information.

Other examples include a “locking up” of data in an operating room, and a failure to display a patient’s allergies due to software errors. The system is largely unregulated and the FDA may suggest some sort of framework of federal oversight which could include requiring the system makers to register with the government and submit reports on safety issues, errors and problems that surface. The systems could even face a pre-market review by the agency before they are launched. Sen. Charles Grassley says there needs to be a national system for reporting errors and product failures. Some manufacturers are resistant to additional scrutiny arguing regulation will not necessarily make electronic medical records safer, while others favor the stepped up scrutiny. Device makers also testified suggesting a patient safety organization be created to collect reports of problems in electronic health systems. Hospitals are interested too in finding out the most they can about safety flaws before they jump forward into the electronics age. After all, patient lives are at stake.

Guidant LLC, a medical device manufacturer, was charged on February 25, with a criminal violation of the Federal Food, Drug and Cosmetic Act in relation to the safety of its implantable defibrillators. Guidant LLC, owned by Boston Scientific Corporation, formerly did business as Guidant Corporation. The Justice Department is expecting a formal guilty plea from the company as part of an agreement and the company has previously announced it would pay nearly a nearly $300 million fine.

Guidant Offenses
What did the company do wrong? Guidant is accused of concealing information from the FDA regarding the failures of some of its lifesaving devices, specifically the implantable cardioverter defibrillators or ICDs short-circuited, specifically three models, the Ventak Prizm 2 DR (Model 1861) and the Contak Renewable (Models H135 and H155). Beginning in 2003, Guidant reportedly became aware that the Ventak tended to arch, rendering the lifesaving device inoperative and unable to deliver life-saving shocks to patients with abnormal heart rhythms. The devices are supposed to constantly monitor the electrical activity of a heart and when it gets out of rhythm, the ICDs is supposed to deliver an electrical shock to the heart to return it to a normal heartbeat. Without that, the patient can die within minutes. In response, Guidant says it changed the design of the Prizm 2 in November 2002 but the Justice Department says the Guidant lied to the FDA when it said the design change did not affect device when in fact it was made to correct the flaw. Guidant had similar problems with the Renewal 1 and 2 devices that resulted in a patient death in July 2004. Under law, Guidant was supposed to alert the FDA, but it failed to do so. The government says that Guidant undermines the FDA’s role to protect the public from dangerous medical devices.

Guidant wants to remind the public that paying a fine is not an admission of guilt.

Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division said, “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law.”

“The community has the right to expect that companies that violate federal law by submitting false or misleading information to the FDA will be held accountable, particularly when that information relates to lifesaving devices, such as defibrillators,” said Frank J. Magill, Acting U.S. Attorney for the District of Minnesota on this case. “I want to thank the prosecutors and investigators responsible for this challenging investigation that resulted in these charges being filed. For that, we all can be very thankful.”

Source Article: http://www.prnewswire.com/news-releases/medical-device-manufacturer-guidant-charged-in-failure-to-report-defibrillator-safety-problems-to-fda-85372982.html

Savella is a drug used to treat fibromyalgia that should be banned says consumer group Public Citizen. The advocacy group has petitioned the Food and Drug Administration (FDA) calling for the Savella ban, pointing out that European regulators refused to approve it as a treatment for fibromyalgia.

What’s wrong with the drug? According to Public Citizen, in two clinical trials, Savella was found to increase blood pressure, heart rate and suicidal thoughts. Patients with normal blood pressure developed hypertension compared to those on a placebo. A hike in your blood pressure rate can increase the risk of a cardiovascular event, a heart attack or death.

Savella also carries an increase in the risk of seizures, addiction, mood disorders, excessive bleeding, glaucoma and gastrointestinal effects. Pregnant woman should not take the drug, says Public Citizen. And besides, says Dr. Sidney Wolfe of Public Citizen, as a treatment for fibromyalgia, it loses effectiveness after three months. With all of the downsides and few upsides, there is very little reason to take this potentially dangerous prescription medication.

And if there is any need for further convincing, the European Medicines Agency has rejected Savella’s approval for fibromyalgia saying its benefits were “marginal” and did not outweigh its risks. After this the FDA approved the drug in January 2009.

Source Article: http://www.bloomberg.com/apps/news?pid=20601103&sid=a0lZW4ldgHns

The always reliable ConsumerAffairs.com has been taking in an unusual number of complaints on those flat screen TVs that everyone must have including Vizio, Sony, Samsung, Philips and Mitsubishi. But the Samsung appears to be having more than its fair share of complaints with 110 postings in the last month the group writes.

Mary of Arlington, Texas writes that “We bought a 52 inch Samsung LCD in 9/2007. It needs a new front panel, probably $1200 to $1,500” she says. Another person says they purchased a 40 inch Samsung about two years ago and now it takes about 20 to 50 clicks before the TV will come on. Another person writes that their 62 inch TV by Samsung clicks off sporadically.

Samsung appears unwilling to help. We believe that a television that costs several hundred dollars should last more than 18 months. It is not unusual for standard tube sets to still be going strong after 20 years of use. When a repairman came to fix the Samsung, one consumer reports that a he replaced two insufficient 10V capacitors with two 25V ones and the television works.

Vizio Problems

Last year, ConsumerAffairs.com received many complaints about the Vizio flat screens that reportedly had the “black screen of death” meaning their screen would suddenly go dark. A repairman from Pikeville Ky. said the screens are cheaply made and the problem in flat screen TVs stems from a power supply failure.

“Most of these sets have three power supplies,” he said. “The main power supply usually holds up but what happens, one of the screen power supplies fails. When that happens the screen goes dark and repairs can be costly, assuming a service provider can get the parts.

“It used to be you could buy a TV set and it would last 20 years,” said repairman Ray Hall. “It’s not like that with these flat screens.”

Defective Products

Consumers essentially form a pact with the companies from who they buy products. The consumer pays money. In exchange, they expect the product to work as advertised, and to be safe. Two years on a flat screen is unacceptable and if enough consumers complain and some they decide to take legal action with a product liability attorney, often that is the only way to get the attention of the manufacturer of defective products. It’s unfortunate, but it is true. #

Source Articles: http://www.consumeraffairs.com/news04/2010/01/samsung_tvs.html

For women over the age of 50, urinary incontinence is a common occurrence. Often a uro-gynecologist will suggest a bladder sling to hold up a prolapsed bladder and reinforce muscles that control the flow of urine.

But many women have problems with the slings and find they must eventually be removed. A lawsuit filed against Johnson & Johnson (J&J) has led to a request for documents necessary to try a product liability lawsuit over Mentor Corp.’s ObTape bladder sling.

A federal judge in Georgia ordered J&J and its subsidiary, Ethicon Endo-Surgery to produce documents in a case against Mentor Corp. Mentor is now owned by J &J after it was acquired in December, 2008 for $1.07 billion.

Defective Medical Device

The Mentor sling is not made of woven material. That means for many women, such as plaintiff Geraldine Doria who has sued Mentor, the sling can block nutrients and oxygen. That can lead to severe pain, and vaginal extrusions, urinary tract erosion and infection.

Doria says the mentor sling has caused significant mental and physical pain since the device was implanted in February, 2005. To complicate matters, the device in her case caused “erosion of her internal bodily tissue, including her vaginal wall and painful infection.” It had to be surgically removed, which often proves difficult.

Doria subpoenaed records from Ethicon related to another product, the Gynecare TVT prolene mesh device, but Ethicon says they’re not relevant to this case and that they contain trade secrets. Ethicon said the subpoena presents an undue burden, but Judge Clay Land of the US District Court for Middle Georgia denied the Ethicon motion, ruling the company must produce the records.

The plaintiff’s content that the Ethicon product, TVT, is a safer feasible alternative design over the ObTape design and that information regarding the TVT design is relevant to a design defect claim and to refute Mentor’s clam that its design is as safe as the TVT design. Judge Land also ruled that Ethicon must produce a pamphlet for the TVT device about how to select the right mesh.

Many consumers may not know that often medical devices do not go through a pre-market approval process the way drugs are required to do. In this case, the Mentor tape cited Ethicon‘s TVT device as its predicate device. That means in its application for approval, Mentor said it was substantially equivalent to TVT. That’s why it did not have to undergo pre-market approval under the 510(k) application, as it’s known by the FDA.

In December, Judge Land decided to allow Mentor Corporation founder and CEO and its president to be deposed by the plaintiffs and reversed his decision to dismiss the case on preemption grounds. #

Source Article: http://massdevice.com/node/5485

The Insurance Institute for Highway Safety is making it easier for parent and child caregivers to choose the safest booster seats that keep kids safe in automobiles. The Institutes rates 9 belt-positioning boosters as Best Bets and 6 as Good Bets out of 60 models. Eleven are not recommended at all.

The purpose of a booster seat is to elevate a child or even a small person so that the seat belt fits properly. Ideally, the lap belt will fit flat across a child’s upper thigh and not across the abdomen which is likely to cause injury in an accident. The shoulder belt should cross snugly over the middle of a child or an adult’s shoulder. That is the best position to be in case there is a crash.

The Institute used crash test dummies to assess the reliability of the boosters in both the lap and shoulder area and cover almost all models currently sold in the U.S. Look for the Combi Dakota backless with clip, Recaro Young Sport highback (combination seat), Recaro Vivo highback, Maxi-Cosi Rodi XR dual-use highback, Evenflo Big Kid Amp backless with clip, Eddie Bauer Auto Booster dual-use highback, Cosco Juvenile Pronto dual-use highback, Britax Frontier highback (combination seat), and Clek Oobr dual-use highback. Look at all of the ratings on the IIHS Web site.

Those that are not recommended include the Harmony Secure Comfort Deluze backless with clip, Combi Kobuck duel-use highback, Evenflo Express highback, Eddie Bauer Deluxe highback, and Evenflo Sightseer highback. There are more on the list that are not recommended.

Source Article: http://www.theautochannel.com/news/2010/01/18/462161.html