Robotic Surgery by da Vinci - Masterpiece or Major Mistake?

Robotic Surgery by da Vinci - Masterpiece or Major Mistake? 

Most of us have experienced the anxiety and frustration of a computer, smartphone, iPad or other device malfunctioning. But what would we do if our lives depended on an electronic device performing perfectly?

 

 

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Transvaginal Mesh and the Wall Street Journal

Author:  Brooke Cohen

The Wall Street Journal put out a timely article today entitled “Outcomes are Mixed for Pelvic Procedure”. I say timely because the product-liability lawsuits against five manufacturers of transvaginal mesh are in full swing, and as a female attorney who is handling mesh cases, this article most definitely caught my eye when it quoted a study published in the Journal of American Medical Association finding, “long-term benefits are limited for women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.”

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One Woman's Story of The Horrors of Surgical Mesh

Stress Urinary Incontinence (SUI) affects approximately 13 million American women.  This embarrassing condition can literally change a woman's life, as she never knows when she'll leak urine while coughing, laughing, sneezing, having intercourse or performing virtually any physical activity.  Suzanne McClain is one of these women. 

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Johnson & Johnson Lawsuits Over Transvaginal Mesh Implants

Transvaginal mesh implants used in surgery – not a fun subject by any means. But worst of all, these implants have been a living hell for the women who suffered the horrible symptoms associated with them.

Yesterday an Atlantic City, New Jersey jury awarded $3.35 million to Linda Gross. The Johnson & Johnson subsidiary, Ethicon, must pay this substantial amount in what is the first of 2,100 lawsuits over the transvaginal mesh implant. Now, punitive damages in this case may amount to as much as $16.75 million.
 

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Energy Shots Under FDA Scrutiny

The Food and Drug Administration (FDA) is currently investigating whether 5-Hour ENERGY shots are the cause of 13 reported deaths, and several hospitalizations.  Because 5-Hour Energy is a dietary supplement, they are not legally required to disclose how much caffeine their product contains.  However, a recent lab report by ConsumerLab.com placed the level at 215 mg per 2oz bottle - whereas a typical cup of coffee ranges anywhere from 100-150mg per 8oz.
 
The company cautions users to only take the product twice a day, several hours apart on the product labeling.  They also recommend not using the product while pregnant or under the age of 12.  However, even when used as recommended, individuals with caffeine sensitivities and health issues (such as heart conditions) should consider avoiding use of the product altogether.
 

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C.R. Bard's Recovery® and G2® Retrievable Inferior Vena Cava Filters Can Cause Severe Injury and Death

The retrievable inferior vena cava (“IVC”) filters manufactured by C.R. Bard, Inc. and Bard Peripheral Vascular, Inc., as well as devices manufactured by CookMedical have a high risk of failure and patient injury.

Studies show  that about 1 out of every 4 IVC filters fracture. These fractures can be splintering and send out painful shards throughout the body that can penetrate the heart and lungs, and can even be deadly.

On August 9, 2010, the FDA published an initial advisory communication regarding all retrievable inferior vena cava filters. This initial advisory warned that from 2005 through 2010 the FDA received 921 adverse event reports involving IVC filters fracturing and migrating within the human body and/or perforating the IVC.

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Johnson & Johnson Hip Implant Recall

Johnson Hip Implant RecallIt’s been over two years since the FDA started getting complaints about the failure of a hip replacement implant manufactured by DePuy Orthopaedics, a division of Johnson & Johnson.  Over 93,000 people worldwide have had hip implant surgery with these devices, and the FDA has had over 400 complaints about it since 2008.  Apparently, the failure happens early after surgery and a second, painful surgery is then required.

The high early failure rate of these implants (called ASR implants) has been known of for some time.  ASR implants are part of a category of implants called metal-on-metal implants that cause debris from wear, inflammation and sometimes even tissue damage.

This is one of many recalls of many of Johnson & Johnson’s best-selling products.  The giant pharmaceutical company is clearly in trouble – if you can call any pharmaceutical company whose earnings are down “in trouble.”  The fact is, Big Pharma cleans up on meds and products.   Last year, DePuy Orthopaedics had sales of almost $5.4 billion – and it’s just a division of J&J!   I wonder if when asked what they wanted to be when they grew up in class, the leaders of these giants said, “I want to be the CEO of a huge pharmaceutical company that sells defective products and dangerous medications, and make a fortune doing it.”

For the full story, click "CONTINUE READING" below.

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Miley Cyrus, Hannah Montana, Brain Damage and Kidney Failure

Wal-Mart Jewelry DangerWal-Mart recently was forced to pull an entire line of Miley Cyrus and Hannah Montana bracelets and necklaces from its store shelves.  The problem?  Cadmium, which can be ingested by kids when they bite, chew, or suck on jewelry.  Ingesting cadmium is even worse than lead.  Cadmium is a known carcinogen that can cause brain damage and kidney failure.  For some reason, girls ages 6 to 11 are at a greater risk for suffering from cadmium exposure.  Hence, the actions taken by Wal-Mart to remove all Miley Cyrus and Hannah Montana jewelry from its shelves.  If you have any Miley Cyrus or Hannah Montana jewelry in your home, you should throw it away or take it back to Wal-Mart and get a refund of your money. 

Image: Wal-Mart Jewelry Danger

Click "CONTINUE READING" below for the full AP Story.

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Nissan Infiniti G35 Recall

infiniti g35 recallA wire problem that can disable airbags is the most recent problem Nissan Motor Co. faces.  Yesterday, Nissan announced it would recall 135,000 Infiniti G35 sedans and coupes.  G35 coupes affected are models built between 2005 and 2007.  G35 sedans from 2005 and 2006 are also part of the recall.  Nissan declared that the air bags in those models could suffer from wear and tear which could cause the bag not to deploy in a collision. 

For more information call 1.800.662.6200.
 

Millions of Baby Slings Recalled

Baby sling dangerOn the heels of an earlier warning about baby sling carriers, the Consumer Product Safety Commission linked 3 infant deaths to suffocation involving Infantino SlingRider and Wendy Bellissimo slings.  According to the CSPC, the slings can press against an infant’s nose and mouth causing suffocation or the sling can otherwise cause a baby’s chin to press against the baby’s chest resulting in suffocation.  The Infantino slings were sold at Target, Babies"R"Us and Burlington Coat Factory from 2003-2010.  Infantino lists details of the recall here and has agreed to replace the product free of charge for purchasers by calling 866.860.1361.

DePuy Orthopaedics/Johnson & Johnson ASR Hip Implant Defect

Johnson & Johnson hip implantDePuy, a division of Johnson & Johnson, warned doctors about the ASR implant in a March 6, 2010 letter.  Apparently, the device has a higher than expected failure rate in some patients.  The ASR was failing in many patients just a few years after implant, causing expensive and painful replacement operations.
 
This action was taken over two years after reports that the ASR was failing.  Although the ASR is not widely used in the U.S., it has been implanted in thousands of patients worldwide.
 
The March 6 letter stated that the ASR has a higher-than-expected failure rate when used in traditional hip replacement on certain type of patients, with the risk being highest for patients of smaller stature - generally meaning women, and patients with weak bones.
 
When a report asked why the company was just now issuing the advisory, DePuy issued a statement that "this is new and important information surgeons who continue to use ASR should have to inform their clinical decision making."  The ASR is only one of many hip models sold by DePuy, and is in a category called metal-on-metal implants.  These implants can generate metallic debris as they wear, causing inflammation in some patients, damage of muscles and other soft tissues and subsequent operations to replace the device soon after implant.  Most artificial hips should last 15 years or more.
 
It is interesting that this announcement comes at a time when the company was phasing out the product anyway, rather than when the reports of failure began pouring in.  But hey, what else is new?  No surprises here when it comes to Big Pharma.

Denture Creams Cause Neurological Problems

GlaxoSmithKline is in the news again.  Glaxo makes and markets Super Poligrip Original, Ultra Fresh,  and Extra Care denture cream products.  Unfortunately, Super Poligrip, Ultra Fresh, and Extra Care denture cream products contain zinc.  For years lawsuits have alleged that zinc in the products causes severe neurological problems.  Some of the neurological problems were severe enough to cripple people.

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Feds Pressure Toyota With Criminal Investigation

The Japanese automaker Toyota now faces a criminal investigation over how it handled safety issues.  As I noted in a previous post, Toyota’s internal documents boasted about the hundreds of millions in savings it was able to earn by defeating previous investigations and lobbying Congress ever so vigilantly.  Now it appears that Congress will test Toyota’s boast and investigate whether Toyota covered up and/or misled investigators looking into sudden acceleration, braking, and other safety problems alleged against Toyota.

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Toyota Executive Concedes, Problems With Toyota May Be Bigger Than Thought

Toyota executives testifying today before Congress suggests that an earlier recall of millions of Toyota vehicles may not solve the acceleration problems Toyota has been charged with.  In testimony before the House Energy and Commerce Committee, several victims of Toyota sudden acceleration problems testified about their harrowing experiences trying to stop runaway Toyotas.  The plot thickens.  See the Full NY Times article by clicking below.

 

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Toyota...Profits Over People

Unless you're living in a cave, you've been hearing and reading about Toyota's problems with the Camry, Prius, and Lexus.  Should you care?  Yes!  Toyota, in a presentation to its staff, reported it saved over $100 million by delaying safety regulations, avoiding defect investigations and otherwise slowing down industry requirements on its vehicles.

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Recalls Recalls, We All Call for Recalls!

Wow, what a week it's been.  First Toyota decides to recall 400,000 Prius and other hybrid cars for braking problems.  Mind you, this was on the heels of a global recall of over 7 million vehicles in recent months because of sudden acceleration and other problems!  It gets worse, Toyota also recalled 7,300 Toyota Camrys to check for a power steering problem.

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Product Safety Standards Won't Change For All The Tea In China

Sometimes I feel like a broken record.  But the real record-breaker is the United States government, which is still allowing the importation of defective children's products from China.  What will it take for the powers that be to finally take action?  Let's see, a boy's three-piece Santa set that causes a choking hazard, horse toy figures with poisonous lead paint, toy helicopters that cause a fire hazard, and the recalls just keep on coming!

We do everything possible to ensure our children's safety, while unbeknownst to us, there's ever-present danger from their own toys! 
 
Please see the press releases issued yesterday by the CPSC by clicking "CONTINUE READING" below.

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Major Recall on Strollers

I previously blogged about Maclaren strollers that were recalled for a fingertip amputation hazard.  Now the Consumer Product Safety Commission (CPSC) announced a voluntary recall from Graco on about 1.5 million of the manufacturer's strollers.  Once again, this recall is due to a child opening or closing hinges on the stroller's canopy, which also causes a fingertip amputation and laceration.  To date, Graco received seven reports of injuries - five fingertip amputations and two fingertip lacerations.  And where are these strollers manufactured? China, of course.  It's time to stop importing dangerous products from countries that employ limited to no safety precautions and bring our manufacturing home!

The full press release from the CPSC follows:

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CPSC Demands Recall of 635,000 Cribs

The Associated Press continues to do its part to keep dangerous Chinese imports from harming our kids.  The AP reported yesterday, "A Barbados-based company on Tuesday recalled about 635,000 cribs sold by Kmart, Sears, Wal-Mart and other stores after the death of a 6-month-old boy and multiple reports of injuries. The Consumer Product Safety Commission announced the recall of 20 models of Dorel Asia cribs with both drop sides and fixed front rails. Some of the Chinese- and Vietnamese-made cribs were recalled because their drop sides can detach, creating a space where a child can be trapped and suffocate or strangled."
       
The Los Angeles Times reports, "The safety commission said a 6-month-old from Cedar Rapids, Iowa, became trapped and died in one of the cribs after the drop-side hardware broke. The agency and Dorel Asia received 31 reports of drop-side incidents and 36 of slat breakage; a total of 10 injuries were reported." Dorel Asia, the crib manufacturer, when questioned about these reports and the death of an Iowa child, said "it learned from a safety investigator that the 6-month-old's crib had been previously broken and that the parents had used duct tape to hold it together." 

I've written extensively about the dangers defective cribs pose to babies and small children.  To see a video of how these cribs can kill, see my interview on Good Morning Texas.
 

Feds Warn Consumers About Harm of Cadmium

Yesterday, Inez Tenenbaum, head of the Consumer Product Safety Commission (CSPC) told parents not to let their children play with cheap metal jewelry, especially when they are unsupervised.  The CSPC noted that it had proof of that lead in children’s jewelry is dangerous and that many imports from China contained lead.  The CSPC also noted that many imports from China also contained cadmium, which is another heavy metal that is dangerous if ingested.  The CSPC cited the AP investigation I wrote about earlier this week.  

In a related development,
Senator Charles Schumer is pursuing legislation that would ban cadmium and other heavy metals from children’s jewelry and toys.  Congress is expected to take the matter up next week when it resumes.

Toy Safety Concerns: Highlight Cadmium

Last month I was interviewed by Good Morning Texas about toy safety.  Toy safety is a year around issue, and it is especially timely before and after the biggest toy giving holiday of the year, Christmas.  As many people know, lead paint in toys is a major safety issue.  I told the Good Morning Texas viewers about lead hazards in toys and children’s jewelry.  I also mentioned a super website, www.toysafety.mobi where parents can go to check the safety ratings of every toy they’re buying. 

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Simplicity Cribs Linked to 11 Deaths

I've previously reported about the problem with Simplicity bassinets. Several recalls since December, 2005, have reduced the number of Simplicity bassinets in people's homes. The Consumer Product Safety Commission now says that at least 11 infants died from the defective bassinets. The most recent death occurred in September 2009 when a 7 month old baby got entrapped in the crib.

If you have a Simplicity bassinet in your house, destroy it. 

Feds Recall 50 Million Roman-Style Shades and Roll Up Blinds

Yesterday, the Consumer Product Safety Commission along with the window-covering industry, recalled over 50 million Roman-style and roll-up blinds due to the strangulation risk they posed to children. Roman shades are problematic because their cords can get wrapped around a child’s neck, which can lead to tragic results. Roll-up blinds pose a strangulation risk if the lifting loop slides off a side and becomes wrapped around a child’s neck.
 
All parents are urged to examine the type of blinds or shades they have in their homes and if they have accessible cords. The best type of window coverings for homes with children are cordless. If you purchases Roman-style or roll-up blinds from Wal-Mart, J.C. Penney, Big Lots, Ace Hardware, Williams-Sonoma, or Pottery Barn, you can obtain free retrofit kits for Roman shades and roll-up blinds at www.windowcoverings.org or you can call the Window Covering Safety Council at 1-800-506-4636.

Importing Injury: Unsafe Cribs

I've talked about recalls of dangerous imported children's products a lot lately, including a baby bassinet causing deaths and a stroller causing amputation of children's fingers.  Now comes the recall of a crib made by Stork Craft that can cause suffocation and other injuries.  The crib is manufactured in China, Indonesia and Canada, where of course, safety standards are lax at best. Please see the full CNN.com article below:

Crib recall: 2.1 million deemed unsafe
Consumer safety officials say drop-side cribs made by Stork Craft can cause suffocation or other injuries.
By Aaron Smith and Ben Rooney, CNNMoney.com staff writers
Last Updated: November 23, 2009: 7:43 PM ET


Drop-side cribs have been recalled by the thousands this year due to hardware malfunctions that could cause infants to be wedged between the mattress and crib wall.

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My Interview About Child Safety In Cars On Good Morning Texas

Please check out my latest interview on Good Morning Texas about the importance of keeping your child safe while traveling on the road.  Included are state regulations and crucial tips to ensuring you protect your children as much as possible.  This is a very critical and timely topic during the holiday season when road travel is at its peak.

Injured By Imports, Chapter 2

Just over a week ago I blogged about a dangerous imported product for children – a baby bassinet that allegedly killed two infants.  Now the nightmare continues with a stroller that amputates fingertips.  And where do you suppose it was manufactured?  You guessed it – China.
 
The Maclaren stroller, sold by Target and Babies “R” Us was recalled today after not one, not two, but a whopping 15 reports of children placing their fingers in the hinge, resulting in 12 reports of children’s fingertips amputated by this “fingertrap.”  Apparently, when the stroller is unfolded and locked into place, a child’s fingertip can get caught in the hinge and get cut off. Can you imagine being the one to unfold a stroller and hear the anguished cry of your child’s excruciating pain?  As a parent, it makes me shudder to even think about it.

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Car Seat Safety in Texas

This past September, 2009, Texas enacted new rules that relate to car safety seats.  Let’s begin with the rules.  Who needs to be in a car seat?  In Texas, all children younger than 8 years old must be in a child safety or booster seat, unless, the child is taller than four feet, nine inches.  Wow, I would have been being driven to high school in a booster seat had that been the law back in my day.  Fortunately, I grew a foot between 9th and 12th grades.  Anyway, back to the rules and regulations.  Keep in mind that while this is a legal requirement, you don’t have to throw out your common sense if the belts in your car fit your child.

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Death by Imports Continues. Baby Bassinet is Latest Killer.

I’ve written a great deal about dangerous products that have resulted in numerous injuries and deaths. It’s no surprise that most of these products were imported from foreign countries such as China and India, where manufacturing is cheap, but safety standards are lax. Examples include Chinese food products, poisonous toothpaste, children’s pajamas, dolls painted with lead contaminated paint, toxic chemicals in plastic toys, and the list goes on and on and on. Now Wal-Mart is facing a lawsuit for selling a defective bassinet that allegedly strangled and killed a 6-month-year-old baby. So where was this bassinet assembled? No surprise here - China. This is the SECOND time a baby has died from this very same bassinet. The first death occurred in September, 2007. Yet despite this horrific incident, the bassinet remained on the market.

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My WFAA Interview on Garage Sale Recalls

Please view the link below for my Friday interview on the WFAA news segment regarding the liability of people selling recalled items in garage sales:

Feds Cracking Down on Resale of Recalled Goods

If you're planning to hold or shop at a garage sale, you should be aware that the federal government is watching. A new federal law makes it a crime to sell items that the Consumer Product Safety Commission has recalled. The Commission has sent staffers out to make sure the bigger thrift stores know about it, but the same law applies to individual sellers.

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The Latest On Shoulder Pain Pump Lawsuits

I was quoted in the following article published on Lawsuit.com about PAGCL (Post-arthroscopic Glenohumeral Chondrolysis) resulting from the use of shoulder pain pumps:

Shoulder Pain Pump Lawsuits: Motion to Consolidate Due to High Volume
original article here
Lawsuit.com

Due to the high number of lawsuits involving shoulder pain pumps across the U.S., motions have been filed to bring all cases forward in one court. Personal injury attorneys are still accepting legal cases relating to shoulder pain pumps that may cause Post arthroscopic Glenohumeral Chondrolysis or PAGCL.

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Healon D Recall

The following article was authored by a friend of mine, Mark Zamora. You can read more from Mark on his blog at www.aGeorgiaLawyer.com.

On Friday, January 2, 2009, The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, California.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

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