While the federal watchdog agency urged patients not to delay or forgo medical procedures for fear of infection, the risks have roused concerns over multiple-use medical devices.

“Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there,” according to the FDA consumer update.

The risks result from improper “reprocessing,” the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.

Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.

The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.

Patients could become infected by other patients, or may suffer tissue irritation from chemical disinfectants or other reprocessing materials left on the device.

If you or anyone you know thinks that you have been hurt by any reused medical device, call us at: 877 882 0095

For original article see: http://www.massdevice.com/news/fda-aims-reused-medical-devices

The study, published in the Archives of Pediatric & Adolescent Medicine, shows the need for better education about the vaccines and their limitations.

Merck’s Gardasil and GlaxoSmithKline’s Cervarix vaccines protect against strains of the humanpapilloma virus or HPV that cause cervical cancer. Gardasil also protects against some strains of the virus that cause genital warts.

But neither vaccine can prevent other forms of sexually transmitted diseases such as syphilis, gonorrhea or human immunodeficiency virus or HIV that causes AIDS.

And HPV vaccines can only prevent HPV infections; they do not treat active infections.

Most girls who get the vaccine know its limitations, the researchers said, but the vaccines are recommended for all girls aged 11 to 12, and overestimating their effect could increase a young woman’s risk of contracting other sexually transmitted diseases.

For the study, Dr. Tanya Kowalczyk Mullins of Cincinnati Children’s Hospital Medical Center and colleagues surveyed 339 girls aged 13 to 21 about their perceptions of risk after their first HPV vaccination. Several mothers also took part.

Overall, most adolescent girls said they believed it was important to practice safe sexual behaviors after getting the shot. But a small group of girls — 23.6 percent — believed they were less at risk for getting sexually transmitted diseases after getting the vaccine.

For original article see: http://www.reuters.com/article/2012/01/02/us-cancer-cervical-idUSTRE8010QW20120102

The eminent surgeon was horrified by what he what he had just witnessed.

His patient, a 36-year-old woman, who had suffered from breast cancer, was undergoing surgery at an NHS hospital to repair the damage caused by the “massive failure” of silicone implants – which she had received as part of a reconstructive procedure.

“It was an almighty mess,” recalled Brook Berry, now 65 and retired to the south of France.

Formerly head of the department of plastic surgery at the University Hospital of North Durham, he was astounded that the implants – made by the French firm Poly Implants Protheses (PIP) – should have ruptured so catastrophically.

His patient had had the implants fitted only three years previously. And here she was undergoing further invasive, serious surgery because the implant in her right breast had leaked silicone into the lymph nodes in her armpit.

For original article see: http://www.telegraph.co.uk/health/healthnews/8986746/Breast-implant-scandal-the-whistleblowers.html

Adderall, a stimulant, is a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug’s active pharmaceutical ingredient (API) can be distributed to manufacturers each year.

The system is designed to prevent the creation of stockpiles that could be diverted for inappropriate use. Adderall and other stimulants are popular with students who may not have ADHD but are seeking to improve their test scores.

The DEA authorizes a certain amount of the API in Adderall – mixed amphetamine salts – to be released to drugmakers each year based on what the agency considers to be the country’s legitimate medical need.

Increasingly that estimate is coming into conflict with what companies themselves say they need to meet demand for the drug, which is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks prescription data.

Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product.

“I am very concerned about the future,” said Ruth Hughes, chief executive of Children and Adults with Attention Deficit/Hyeractivity Disorder (CHADD). “No one seems to have much inventory to get us through the months ahead.”

For original article see: http://www.reuters.com/article/2012/01/01/us-adhd-adderall-shortage-idUSTRE80009E20120101

The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, “we do not believe the data will support approval” although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.

Results of the studies are in Thursday’s New England Journal of Medicine.

If you or anyone you know has been hurt from taking Avastin, call us at: 877 882 0095
Read more: http://healthland.time.com/2011/12/29/avastin-disappoints-against-ovarian-cancer-too/#ixzz1hw5xyf1U

Name of Product: Rayovac NI-CD Cordless Tool Battery Packs

Units: About 111,800

Importer: BatteriesPlus LLC, of Hartland, Wis.

Hazard: The replacement battery pack can explode unexpectedly, posing a risk of serious injury to consumers.

Incidents/Injuries: BatteriesPlus has received five reports of exploding batteries. No injuries have been reported.

Description: This recall involves RAYOVAC-branded replacement battery packs used with cordless power tools. “RAYOVAC,” “NI-CD” and a part number beginning with “CTL” are printed in white lettering on the product. The battery packs were sold in voltages ranging between 2.4 and 18 volts in various sizes and shapes. They were sold as replacement batteries to the following brand tools: Black and Decker, Bosch, DeWalt, Makita, Milwaukee, Panasonic, Ryobi and Skil.

Sold exclusively at: BatteriesPlus retail stores nationwide and online at www.batteriesplus.com between June 2008 and October 2011 for about $60.

Manufactured in: China

Remedy: Consumers should immediately stop using and remove the battery packs from cordless tools. Consumers can contact BatteriesPlus for instructions on how to return the product for a store credit.

Customer contact: For more information, contact BatteriesPlus toll-free at (877) 856-3232 between 9 a.m. and 4:30 p.m. CT Monday through Friday, or visit the firm’s website at www.batteriesplus.com

If you or anyone you know has been hurt by the Battery Plus Battery Packs, call us at: 877 882 0095

For original article see: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12063.html?tab=recalls

The problems had to do with PIP’s saline implants, a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm’s bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP.

The French government last week recommended that women in France who have PIP’s silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks.

A critical question is why the FDA’s warning didn’t trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere. Officials at the FDA and France’s health regulator were not available for comment on Monday on whether the FDA shared information about its inspection of the PIP plant, though the warning letter was made public in 2000.

POOR HEALTH

No one has been charged in the case.

Sources said a Marseilles court could soon announce fraud charges against four to six ex-PIP employees.

There is also an investigation into involuntary homicide by French authorities, following the death from cancer of a woman last year. She had received PIP implants. The French government has not presented any evidence of an increased cancer risk from the product.

IF you or anyone you know has been hurt by the Poly Implant Prothese, call us at: 877 882 0095

For original article see: http://www.reuters.com/article/2011/12/27/us-breastimplants-fda-idUSTRE7BQ03M20111227

Since 2009, there have been more than two hundred adverse reports where people claimed that the Conserve Hip Implant failed to do what it was promised to.

At year end, there is now a pending Petition for an MDL regarding those cases. The issues relate to the Conserve Plus Total Hip Replacement System and the Conserve Plus Resurfacing System. The total replacement system has four parts–  a metal femoral stem, metal femoral head, metal modular neck and the metal Conserve cup. The resurfacing system has two components: the metal femoral head cap and the Conserve Plus metal acetabular cup. Both systems are intended to be used as a hip-replacement implant when a patient’s hip joints are damaged or diseased as a result of fractures, osteoarthritis, rheumatoid arthritis and avascular necrosis.

The common component in both systems—and what is at the heart of the lawsuits—is the “Conserve cup”, which is a cast cobalt chromium molybdenum piece that holds the metal femoral head, mimicking the natural movement of a hip joint. It is that unlined cobalt part that is allegedly causing serious harmful effects to patients who receive the implant device. The problem is that these two metal components cause the release of metal particles around the hip joint and surrounding tissue. As a result, a high percentage of patients have developed metallosis and biologic toxicity and are experiencing a high and early failure rate of the device.

If you or anyone has been hurt by the conserve hip systems, call us at: 877 882 0095

The FDA has received a report of a patient with MS who died within 24 hours of taking the first dose of Gilenya.

FDA has said it cannot conclude whether the drug resulted in the patient’s death, but was evaluating the case.

The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.

The drug’s maker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug.

If you or anyone you know has been hurt by Gilenya, call us at: 877 882 0095

Source: http://news.yahoo.com/novartis-ends-study-drug-high-risk-patients-072623672.html

Joey James, an attorney representing Abernathy’s widow, Aretha Abernathy, said Abernathy and at least 16 other workers involved in demolishing the chlorine plant were exposed to high levels of mercury.

Occidental Chemical and its parent company, Occidental Petroleum, and an affiliate, Glenn Springs Holdings, were named as defendants along with two employees and three contractors.

The lawsuit contends the defendants failed to maintain safe working conditions for workers who help demolish the chlorine plant, which was shutdown in 2008.

James said Bobby Ray Abernathy was an employee of Shaw Global Energy Services, as were 16 plaintiffs who claim they became sick while working at the Muscle Shoals plant. Shaw Global Energy Services, which is based in Louisiana, has been named as a defendant in a worker’s compensation claim filed by construction workers who say they were exposed to high levels of mercury while working on the project.

For original article see: http://www.timesdaily.com/stories/Lawsuit-contends-Muscle-Shoals-plant-poisoned-workers,185596