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.”

Unfortunately, I have found when talking to countless women suffering from the aftermath of transvaginal mesh surgeries that the mesh actually exacerbated their incontinence rather than eradicating it. I also have found that not only do the women have increased problems with bladder function, but they also face regular urinary tract infections, ongoing yeast infections, and constant pelvic pain. Some women actually feel the mesh falling out through their vaginas.  Other women are now celibate because of the pain the mesh causes them during intercourse.  Innumerable women have told me that they are unable to leave their homes for long periods of time for fear that their “diapers” they are now having to wear will leak when prior to the surgery they did not have such problems. So while some may say that the “outcomes may be mixed” for women having transvaginal mesh surgery, it seems to me that the problems greatly outweigh the promised benefits of its use.

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. 

I will report more about Suzanne's plight in my next blog entry. Stay tuned.

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.
 

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.
 

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.

More than two years after the Food and Drug Administration began receiving complaints about the failure of a hip replacement implant made by the DePuy Orthopaedics unit of Johnson & Johnson, the company said Thursday that it was recalling two kinds of hip implants.

DePuy said that it had made the decision to withdraw the products because many patients required a second hip replacement after the company’s implants had failed.

The news compounded problems for Johnson & Johnson, which has recalled a succession of some of its best-selling and best-known products, including liquid children’s Tylenol in the United States and, just this week, Acuvue contact lenses in Japan and other countries in Asia and Europe. The Tylenol recall led to the temporary closing of a plant owned by the McNeil Consumer Health Care unit, which is the subject of a federal inquiry over its handling of recent recalls of over-the-counter products.

In addition to DePuy’s recall, the F.D.A. this week criticized the company in a warning letter, contending that it had illegally marketed an unapproved knee device and had also sold a hip implant for an unapproved use. (A spokeswoman for DePuy said that the company was examining the F.D.A.’s concerns.)

“All this makes it seem like it’s pile-on time for J.& J.,” said William Trombetta, a professor of pharmaceutical marketing at Saint Joseph’s University in Philadelphia. “This is a company that was purer than Caesar’s wife, this was the gold standard, and all of a sudden it just seems like things are breaking down.”

In the latest Johnson & Johnson case, DePuy said in a statement that it was recalling two products: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. The traditional implant has been available worldwide, and the resurfacing implant was approved for use in countries outside the United States.

About 93,000 of these devices have been implanted worldwide, said Lorie Gawreluk, a DePuy spokeswoman. The New York Times reported in March that for more than two years, the F.D.A. had been receiving complaints that the devices failed early in some patients, requiring expensive and painful operations to put in new hip replacements. Since the start of 2008, the F.D.A. has received about 400 complaints involving patients in the United States who received the devices, an agency spokeswoman said Thursday.

DePuy said that the majority of hip replacements using the ASR devices had been successful. But the company advised patients who had had hip replacements with the recalled products to visit their surgeons for an evaluation and annual monitoring. The company said it would pay reasonable and customary medical costs associated with the recalled products, including new hip replacement operations.

DePuy had sales last year of about $5.4 billion, according to a Johnson & Johnson earnings report.

The high early failure rate of the ASR implants was reported this year in severalarticles in The New York Times. These devices have come under scrutiny over the last few years because they are part of a category of implants called metal-on-metal bearings, which can generate debris from wear, causing inflammation and tissue damage in certain patients.

In March, the British agency that regulates medical devices issued an advisory on metal debris generated by hip implants. A spokeswoman for the F.D.A. said the agency was planning to meet soon with professional medical groups to discuss the British advisory.

Late last year, DePuy said it was phasing out the implants because of slowing sales. In March, the company warned doctors that the implants might have a high failure rate in some patients.

In one New York Times article, some orthopedic experts expressed dismay that DePuy had not halted sales of the devices earlier. About 12 to 13 percent of patients needed a second hip replacement within five years of receiving an ASR implant, the statement from DePuy said, citing new unpublished data from a national registry in Britain. Previously reported follow-up data, including internal company information and clinical trials, had reported lower rates of second hip replacement comparable to similar devices by other companies, the statement said.

But many medical centers in the United States that specialize in joint replacement surgery had already noticed a higher failure rate with the DePuy hip implants, said Dr. Joshua J. Jacobs, the chairman of orthopedic surgery at Rush University Medical Center in Chicago.

“Most major medical centers have seen issues with this device,” Dr. Jacobs said. “This does not come as a surprise.”

Dr. Jacobs added that the DePuy recall pointed to the importance of having a national registry for joint implants that can serve as an early warning system for product problems. Britain, Australia and some other countries have such national registries, he said, but the reporting system currently used by the F.D.A. does not necessarily capture every device failure.

David Floyd, president of DePuy, said in a statement that the recall would be a concern for patients and their family members and for surgeons.

“We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall,” he said.

Johnson & Johnson comprises more than 250 different operating companies in 60 countries. But the recent recalls and F.D.A. warning letters to several units at Johnson & Johnson raise questions about whether there may be companywide problems, industry analysts said.

“No. 1, is there a systemic issue at J.& J.?” said Rick Wise, an analyst at Leerink Swann, a health care investment bank. “No. 2, is this” hip implant recall “reflective of that systemic issue? And, No. 3, is there more to come?”

Mr. Wise added that F.D.A. warnings and J.& J. recalls had come at a time of increased vigilance about product safety by the agency and health care companies. He said that he believed the various problems at J&J were separate and not part of a systemic issue.

Dr. Trombetta, the pharmaceutical marketing professor, compared Johnson & Johnson to Toyota, another multinational firm whose reputation has suffered this year during a series of recalls. The recalls may be tarnishing Johnson & Johnson’s apple-pie image, Dr. Trombetta said, but he predicted that the company would eventually recover public trust as Toyota largely had.

Shares of Johnson & Johnson closed at $57.80 on Thursday, down 18 cents.

Image: Wal-Mart Jewelry Danger

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

Small pieces of children's jewelry, purchased at various Wal-Mart stores across the country, were found to contains the toxic metal cadmium in tests. (AP Photo/Phil Long)

by JUSTIN PRITCHARD
Associated Press
Posted on May 19, 2010 at 4:56 PM

LOS ANGELES (AP) — Wal-Mart said Wednesday it is pulling an entire line of Miley Cyrus-brand necklaces and bracelets from its shelves after tests performed for The Associated Press found the jewelry contained high levels of the toxic metal cadmium.

In a statement issued three hours after AP's initial report of its findings, Wal-Mart said it would remove the jewelry, made exclusively for the world's largest retailer, while it investigates. The company issued the statement along with Cyrus and Max Azria, the designer who developed the jewelry for the 17-year-old "Hannah Montana" star.

Wal-Mart Stores Inc. had learned of cadmium in the Miley Cyrus jewelry, as well as in an unrelated line of bracelet charms, back in February, based on an earlier round of testing conducted at AP's request, but had continued selling the items. It said as recently as last month that it would be too difficult to test products already on its shelves.

In its statement, Wal-Mart did not say whether it would also remove the bracelet charms.

Exactly how many of the items have been sold was unclear. The charms — also available exclusively at Walmart stores — were sold under the name "Fashion Accessories," though Wal-Mart has not said when they began appearing on shelves. The Miley Cyrus jewelry hit stores in December.

Long-term exposure to cadmium can lead to bone softening and kidney failure. It is also a known carcinogen, and research suggests that it can, like lead, hinder brain development in the very young.

Cadmium in jewelry is not known to be dangerous if the items are simply worn. Concerns come when youngsters bite or suck on the jewelry, as many children are apt to do.

Wal-Mart said that while the jewelry is not intended for children, "it is possible that a few younger consumers may seek it out in stores."

"We are removing all of the jewelry from sale while we investigate its compliance with our children's jewelry standard," Wal-Mart said.

That was a reference to a policy Wal-Mart voluntarily implemented last month, under which suppliers are required to prove their products contain little cadmium, or else Wal-Mart would not accept them.

The company's policy of not checking products already on the shelves appears to have changed: In its statement, Wal-Mart said it reviewed children's jewelry and pulled "the few products that did not" comply with its new testing regimen.

Cadmium in children's jewelry became a public concern in January when the AP published the results of an investigation that showed items at Walmarts and other large chains were as much as 91 percent of the toxic metal by weight.

That testing was conducted by chemistry professor Jeff Weidenhamer of Ashland University in Ohio. In February, Weidenhamer was asked to provide to Wal-Mart headquarters detailed results of tests on items he bought at Walmarts as part of testing he had done for AP. Those items included 10 of the charms and three from the Cyrus line.

To judge the continued availability of pieces that Wal-Mart has known were contaminated, AP dispatched reporters throughout the country last month to buy any of the 13 items they could find. The packaging said they were made in China; all were bought for $6 or less.

All but one of the 13 were on store shelves in the eight states where AP reporters looked. Contrary to Wal-Mart's statement Wednesday, which said the Miley Cyrus jewelry was sold in the women's apparel section, AP reporters found the items either in the jewelry section or discount bins.

The items were then tested by Weidenhamer. Of 61 samples, 59 contained at least 5 percent cadmium by weight, with 53 of those measuring 10 percent or higher.

Weidenhamer's prior research has shown that the testing method he used — an X-ray gun that can roughly tell the amount of cadmium in an item — typically underestimates how much is present.

Representatives of the jewelry industry have argued that the presence of cadmium, even at high levels, is not by itself proof that an item is dangerous. The important thing, they say, is how much can escape if the item is sucked, bitten or swallowed.

Lab testing conducted by Weidenhamer at AP's request showed that several items easily shed the metal when exposed to a mixture that simulated human stomach acid.

The day after AP's original report, Wal-Mart said it was pulling two of the highlighted items — pendants with themes from the Disney movie "The Princess and the Frog." Within three weeks, the chain had agreed to recall all the pendants already sold.

Since then, the U.S. Consumer Product Safety Commission has issued two more recalls, for charm bracelets sold at the international jewelry chain Claire's and at a Dollar N More store. Last week, the agency's spokesman said there will be more recalls.

While AP's January investigation focused on jewelry clearly intended for children, the items tested for AP this time were labeled "not intended for children under 14 years." That is an important legal distinction: Under current law, children's items are defined as for kids 12 and under, and children's products are subject to regulations that others are not.

For reasons that are not fully understood, girls ages 6 to 11 — an age range that includes many fans of Cyrus' "Hannah Montana" TV show, movies and CDs — appear to be more at risk from cadmium.

Data from a major national study found that girls of that age absorb more cadmium than other children or adults, according to Bruce A. Fowler, a toxicologist with the Centers for Disease Control and Prevention.

The increased absorption could be because those girls typically have iron deficiency and their bodies grab on to cadmium as a substitute, Fowler said, or it could be because they encounter more of the metal in objects such as jewelry.

The importer of the bracelet charms, Cousin Corp. of America, said that earlier this year, it persuaded one of the Chinese factories with which it works to stop using cadmium. The cadmium-heavy jewelry Weidenhamer tested was produced in 2008 and 2009 at the problem factory, said Roy Gudgeon, vice president of merchandise at Florida-based Cousin.

"Our intention as a company is to never willingly cause harm to a child," he said.

Federal regulators' own research says that kids start becoming interested in making their own jewelry around ages 6 to 8. As for products featuring Cyrus, her fans include teenagers, tweens, even kindergartners.

For more information call 1.800.662.6200.
 

“We need to be vigilant and continue to investigate all the complaint of the consumers,” Mr. Lentz said.
 
Mr. Lentz also told the committee that Toyota was installing a new brake system that can override the gas pedal on almost all its new vehicles and most of those already on the road. He said that more than 800,000 recalled vehicles have been repaired.
 
Mr. Waxman, while criticizing Toyota’s response to the recall, told Mr. Lentz: “We need to be sure that you’re doing a full and adequate analysis of something you’ve denied, but that other witnesses have shown us is very possible.”
 
“Consumer complaints need to be taken seriously,” Mr. Waxman said in his opening remarks. “The possibility of electronic defects must be actively investigated.”

In a confrontational back-and-forth, Representative Edward Markey of Massachusetts told Mr. Lentz, “You said you had solved the problem, you don’t know if you have solved the problem.”

Referring to the tests the company is running on its computer systems, Mr. Markey added, “You’re only at the beginning of your investigation.” 

“We have not seen failures,” Mr. Lentz reiterated.

Since last fall, Toyota has recalled more than eight million vehicles worldwide — more than six million in the United States alone — in two actions related to complaints about accelerator pedals that can stick, making it hard to stop the vehicles. Witnesses before Mr. Lentz detailed how an electronic problem could have caused sudden unintended accelerations.

And one witness, Rhonda Smith, recounted the harrowing moments of Oct. 12, 2006, when her Lexus sedan sped out of control at 100 miles an hour.

Ms. Smith told the energy committee that she furiously pushed buttons, shifted gears, and slammed on the brakes as she tried to stop the vehicle, Finally, after six miles, she was able to stop the car.
 
She was the first witness in the first of three hearings on Toyota’s recall of millions of its cars. In their opening remarks, lawmakers said they wanted to understand why the Toyota failed to adequately respond to reports of the unintended acceleration, and they questioned whether the car’s computer system was at fault, rather than, as Toyota asserts, the floor mats and gas pedals.

Ms. Smith told the committee that she felt that Toyota’s response to her complaint was “a farce.” She said a company technician told her he was not able to replicate the episode and suggested that it was caused by pressing on the brakes while the tires were spinning.

“Of course we were insulted, and furious over being called liars,” Mrs. Smith said.

Later, Mr. Lentz said he was “embarrassed about what happened” to the Smiths. “We’re going to down and get that car and see what happened,” he said.

Mr. Lentz grew emotional when he spoke of losing his brother in an auto accident 26 years ago. “There’s not a day that goes by that I don’t think of what these families go through,” he said, his voice breaking.
 
Asked why Toyota had moved away from a business model that prized quality and openness, Mr. Lentz offered a simple explanation: “We lost sight of our customers.”
 
“We outgrew our engineering resource,” he said. “We’re suffering from that today.”
 
Lawmakers on Tuesday repeatedly pointed out that their only goal was the safety of the American consumer.
 
“Safety must come first,” Mr. Waxman said while also faulting investigators at the National Highway Traffic Safety Administration for not aggressively pursuing problems with Toyota vehicles.

Representative Marsha Blackburn, a Republican of Tennessee said the goal was to “make sure that mistakes of the past are not repeated and to be responsible when so much is on the line.” Tennessee has a plant from Denso, a major Toyota supplier, as well as a Nissan factory and a Volkswagen plant under construction near Chattanooga.
 
In a statement prepared for delivery to House Oversight and Government Reform Committee on Wednesday, the president of Toyota, Akio Toyoda, said he took full responsibility for the safety crisis facing his company.
 
Mr. Toyoda, in his statement, said he feared the pace at which the company grew in the last decade was too quick. Toyota increased its global sales by about 50 percent, in part by building plants around the world, and became the world’s biggest auto company in 2008.
 
Traditionally, he said the company’s priorities had been safety, quality and volume. But in its growth spurt, “these priorities became confused, and we were not able to stop, think and make improvements as much as we were before,” he said in the prepared testimony. “We pursued growth over the speed at which we were able to develop our people and our organization. I regret that this has resulted in the safety issues described in the recalls we face today, and I am sincerely sorry for any accidents that Toyota drivers have experienced.”
 
And he apologized to members the Saylor family, which was involved in an accident last fall in San Diego that killed four people and brought the issue of sudden acceleration into the spotlight.

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.