Posted On: October 22, 2008

FDA Issues Public Health Notification of Serious Problems With Surgical Mesh Used to Treat Pelvic Organ Prolapse and Urinary Incontinence in Women

Surgical mesh products are medical devices used to fix everything from hernias to prolapse of pelvic organs (uterus) to urinary incontinence seen in women sometimes after they have had several childbirths. These products can be rejected from the body and cause alot of complications sometimes making the original problem look minor compared to the ultimate problems caused by use of the mesh product. Yesterday, the FDA issued a public health notification to both physicians and consumers of the potential risks that can arise from use of these mesh products to repair some of these problems.

Specifically with regard to women who choose to have surgical mesh to address prolapse of their uterus or urinary incontinence, the FDA reports complications with the placement of this mesh including erosion through the vagina, infection, pain, including pain during sexual intercourse and recurrence of the prolapse or incontinence. In fact, a second surgery may be required to address removal of the mesh that has eroded into the vagina.

The FDA recommends many questions which need to be asked of your doctor if you need to have Pelvic Organ Prolapse or Stress Urinary Incontinence surgery. For a list of these questions, see the FDA's Consumer Information on this here.

As a consumer and potential patient, you must be aware of these potential problems and you must discuss them with your doctor to make the right decision for you. If your doctor is not willing to address your concerns or blows them off as not important, you need to find yourself a new doctor. As I said, with use of these mesh products, sometimes the repair and the ultimate results can be much worse than the original problem. Rule number one when dealing with doctors prescribing medications and recommending surgeries; ask questions and demand clear, understandable answers. It is ultimately your life and you need all the necessary and relevant information to make the right decision for you.

Posted On: October 22, 2008

Recalls of the Week

The past week has been a little crazy with my son in college home for "fall break" (not sure why he needed the break since he has only been in school for about a month) and then a quick trip to South Florida for a family celebration. Back this week to keep fighting the good fight. There have been several significant recalls of products this past week and so here we go...

1. Delta Enterprise Drop Side Cribs: Over 1.5 million cribs manufactured by Delta Enterprise are being recalled because they are missing safety pegs which can cause entrapment and suffocation. If you have been following my Recalls of the Week for the last several weeks, there have been a significant number of cribs/bassinets recalled over the past month or two. This is one of the largest so far. The recalled cribs have date codes between 1995 through December 2005 and one model was made in 2007. The cribs were sold at Wal-Mart, Kmart and Target.com. Parents are being told to stop using the cribs that are missing a safety peg on any leg of the crib and contact Delta to receive a free repair kit. For more information on this recall see here and here. Additionally, the Wall Street Journal wrote a news report addressing this recall and Consumer Reports has also issued a report. Consumer Reports also recommends that if you are in the market presently to by a crib, it is safest to choose one with sides that don't go down. It also requests that the Consumer Product Safety Commission work on issuing stronger standards regarding crib durability.

2. Rage Wireless Guitars for Wii Video Gaming System: This recall was just issued today and given the significant interest in Guitar Hero and similar video games, I felt this was important to pass along. The Rage Wireless Guitar is designed to be used on the Nintendo Wii gaming system. The guitar is blue or white and contains battery operated LED- lighted fret buttons on the guitar neck. It is reported there is a circuit board defect which can cause the AA batteries used in the guitar to leak if the batteries are installed incorrectly which can cause chemical burns. Consumers are instructed to stop using the guitars immediately and return them to where it was purchased for a full refund. Sorry kids, maybe you should try playing a real guitar.

3. General Power Products Portable Generators: With winter just around the corner, thought this recall of portable generators would be important to publicize. This recall involves the General Power Products 6000 Watt portable generator and the Poulan Pro 6000 Watt portable generator with serial number 060400483 through 060600725. These generators were sold in hardware and home improvement stores in Illinois, Indiana, Louisiana, Ohio and Texas between June 2008 and September 2008. The problem is the generator's fuel valve can be damaged by the cover plate during shipment and cause a fuel leak during use. This creates the potential for fire. If you have one of these generators, you should stop using it immediately and call General Power Products to find out if the generator's fuel valve is damaged and if so, obtain a free repair kit. For more information, see here.

4. Gen Netcom's GN9120 Wireless Headset: Approximately 525,000 of these wireless headsets typically used in office settings, are being recalled because there is an internal short circuit which can cause the batteries to overheat, leading to a risk of fire. Imagine talking on the phone through the head set and all of a sudden your hair is on fire...OUCH. There have been 10 reports of overheating, including 3 reports of open flames. These headsets were sold nationwide between January 2005 and September 2008 for between $150 and $350. You are instructed to stop using and unplug this head set immediately and call the manufacturer to obtain a replacement battery. For more information, see here.

5. Dextroamphetamine Sulfate 5mg Tablets: ETHEX Corporation is recalling 3 lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5mg tablets due to the potential that some of the tablets may be oversized and contain as much as twice the amount of medication you should be receiving. These lots were distributed between January 2007 and May 2008 and the pill is an orange round tablet with "ETHEX" on one side and "311" on the other side. If you take more than the expected dose, it can lead to rapid heart beat, high blood pressure, tremors, decreased appetite, headache, dizziness, blurred vision and stomach upset. There are several manufacturers of this product so check to see that, if you are taking this medication, it is the one manufactured by ETHEX. You should not use any of these tablets which appear oversized. For more information, you can contact ETHEX at 1-800-321-1705. You might want to consider contacting your pharmacist and try and determine if the medication you have is part of the lots that are included in this recall. For more information, see here.

Well that's it for this week of recalls. Remember to be careful out there and have a safe and happy rest of your week.

Posted On: October 18, 2008

Genentech and FDA Announce New Black Box Warning for Raptiva

It was announced yesterday that Raptiva, a drug used to address psoriasis, has received a black box warning (the highest warning a drug can get) that taking of the drug increases the risk for certain viral and bacterial conditions. The new warning highlights increased risk for sepsis, viral meningitis, and other potential serious infections.

According to the FDA's press release regarding this label change:

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

For further discussion of this new warning and the reasons for it, see Pharmalot's discussion of this label change.

Posted On: October 15, 2008

Preemption - Wall Street Jounal Reports How Bush Trying to Take Away Right to Sue for Unsafe Products in His Final Days

As you are aware if you have followed my blog over time, the issue of preemption and how our right to access to the courts to address injuries caused by unsafe products is being taken away under our unsuspecting noses, has been a continuous crusade of mine. My previous discussions of this issue and what it means to the everyday consumer of products can be found here. 933364_keep_out.jpg

Well, the Wall Street Journal reports today how the Bush Administration, even in its last days, as the country's economy slowly burns to the ground, is doing everything it can to continue to block consumers' access to the court system when they are injured by defective products. The Bush administration couldn't do it the upfront way by bringing it to Congress and let it be debated in front of the American public. Instead he did it the quiet, back door way by having the various federal agencies involved in regulating products; the FDA (drugs and medical devices), NHTSA (cars and trucks) and CPSC (all other consumer products) create rules that incorporate provisions that indicate a consumer injured by a defective product which the applicable agency approved to be marketed cannot seek redress for his or her injuries in a court. Sorry, if the agency says the product is ok, that's good enough.

The American Association for Justice (AAJ) has issued a press statement and a significant paper entitled "Get Out of Jail Free -- How the Bush Administration Helps Corporations Escape Accountability" explaining in detail what the Bush administration has done over the last 8 years to take away our rights as consumers to seek redress in our courts for injuries caused by defective and unsafe products. What the Wall Street Journal article points out is that even with a new administration in power who does not agree with this underhanded method of cutting off our right to access to the court system, it could take several years to change the regulations issued by these agencies under Bush. Maybe if the Bush Administration spent more time over the last 8 years studying the economy and properly regulating the banking industry instead of figuring out ways to take away our right to access to the court system to address our injuries, we might not be waking up every morning now hearing the words "recession", "depression" and "crash".

Posted On: October 14, 2008

Recalls of the Week

That time again friends to explore what has been going wrong in the products world while the rest of our world is completely off its axis. I seem to be spending most of my free time watching the economic and political pundits go on and on about the potential for a depression, our government investing in private enterprise ( can we say "conservatives" promoting socialism???) and whether the ethics of a candidate running for the second highest office in the U.S. really matter. One thing I have always prided myself on and which I use to evaluate people passing through my own life is "are they a good person" . Isn't that what ethics is all about? Doing the "right thing". I will now get off my soapbox and onto the issue at hand; what products do you need to be concerned about this week.

1. Nerf N-Strike Recon Blasters: About 330,000 of these Nerf bazooka type toys are being recalled because the Blasters' plunger can pull the user's skin when it is fired which can cause injury to the face, neck or chest. Already 46 reports of injuries have been received involving children between the ages of 4 and 12. These Blasters were sold at the usual; Wal-Mart, Target and Toys "R" Us between November 2007 and August 2008. The recall instructs parents to take the Blaster away from the child immediately and contact Hasbro at 1-800-245-0910 for a cover to prevent injuries. For more information, including how to identify if you have one of the problematic Blasters, see here.

2. General Electric Toasters: GE Toasters sold at Wal-Mart between September 2007 and July 2008 are being recalled because of an electrical short issue, which can cause a fire or electrical shock. Wal-mart has received 140 reports of fires and sparks coming from the toasters. (Yes, but was the toast burnt???) The recalled toasters have a chrome body, black plastic base and are either 2 or 4 slice toasters. The model numbers involved are 169115 and 169116. If you have one of these toasters, you should stop using it immediately and return it to your local Wal-Mart for a full refund or replacement. See here for more information regarding this recall.

3. Rack Room's Girls' Sandals: Now here is a new one on me...recall of shoes!! Rack Room Shoe Stores, between February 2008 and June 2008 sold sandals for little girls with attached leather flowers. The shoes were sold under the brand name "Kids Feet". The sandals are white or white with pink soles. The ornamental leather flowers can detach and create a potential choking hazard for little kids. If your child has these shoes, you should take them away immediately and return them to the store where you purchased them for a refund or store credit. For more information regarding this recall and a photo of the shoes involved, see here.

4. Pottery Barn Wooden Hammock: Pottery Barn is recalling Wooden Hammock Stands, which, when use outdoors (where else would you put a hammock???) can deteriorate and break over time posing risk of falls and lacerations to users of the hammock. These Hammock Stands have been sold via the Pottery Barn catalog and website between March 2003 and July 2008. If you own this product, you are instructed to remove the two top side brackets of the hammock stand and dispose of the remaining parts of the stand. Contact Pottery Barn to receive a free pickup of the brackets (I guess proof you had the stands) and receive a merchandise credit. Just an aside: the hammock stands are made of wood. Did they not realize from the start that these would deteriorate over time when being used outside, as they knew they would, and break? That, in the products liability world, is called "foreseeability" which you much show to hold a manufacturer responsible for a defect in a product. For more information on this recall, see here.

That is all I have for you this week on recalls. Please remember to be careful out there, and if you need any further assistance regarding a recalled product or a product you have been injured by, please contact us either by calling the number shown above or filling out the "contact" form above.