January 5, 2012

Transvaginal mesh and condoms – FDA Class II

Your doctor will or has already implanted transvaginal mesh into your pelvic vaginal area. It is a medical device and has the same FDA classification as a condom.

Based on an increase of adverse event reports submitted to the FDA, evaluation of published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.

Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.

Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices -- the same as implantable transvaginal mesh.

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May 7, 2009

Philadelphia Law Department Urged to Sue CVS for Selling Expired Products

The website philly.com reported in an account on March, 25 2009 that Philadelphia community groups and city council members urged the city’s law department to sue the drugstore chain CVS for continually selling expired products and exposing the public to unsafe drugs in Pennsylvania.

Shelley Smith, city solicitor, was called upon during the City Hall Press conference to follow California and New York legal action suits taken against CVS. CVS was sued in December by New York State for the sale of expired products. Edmund Brown, California’s Attorney General, requested in June 2008 that the pharmacy remedy its problem after coming across 26 Southern California stores. Currently, California is pursuing suing CVS.

Lance Haver, Philadelphia Community Affairs Director, said, “CVS should spend the money it needs to clear the shelves of expired products that are putting our children at risk.”

Maria Quinones Sanchez, Councilwoman, said, “CVS has been caught selling expired products in our City and around the country. It is outrageous that we are here today calling on a corporate citizen to remove dangerous products from the shelves.”

Expired products found at 15 CVS stores in Philadelphia ranged from infant formula, to over-the-counter medications, and dairy products. Tablets to treat allergies were over a year old and baby’s gas relief medicine was nearly two years expired.

Bill Greenlee, Councilman, stated that legal action was required to protect the community from dangerous items sold at CVS drugstores.

Consumer class action lawsuits in Philadelphia are among the most effective tools consumers have at protecting their power over the marketplace. When a large corporation does something that adversely affects a large group of people, a class action lawsuit enables all of the affected people to act with one voice.

Anapol Schwartz represents consumers, small businesses, and injured people in class action lawsuits throughout the country, seeking money damages and other relief in the federal and state court systems.

If you or someone you know been wronged or harmed due to a company’s negligence contact Anapol Schwartz. They have helped their clients for over years and they know the law and court system to get you the compensation you deserve. Please call the experienced Philadelphia personal injury attorneys at 1-866-735-2792 for a free consultation.

March 11, 2009

Deposition Of Landlord In Toxic Day Care Revealed

An article published on philly.com discussed the revelations contained in the deposition of Jim Sullivan III. Sullivan is a Gloucester County real estate broker who acquired a contaminated building and rented it out as a day-care center.

The deposition revealed that Sullivan did not feel an environmental cleanup was necessary despite the fact that the building was once home to a thermometer factory with a history of mercury spills. Testing later revealed that the property contained hazardous vapors 27 times the acceptable limit. Mercury was also detected in cracks and crevices of the floors and ceilings.

Mercury and most of its compounds are extremely toxic and can be inhaled and absorbed through the skin and mucous membranes. Exposure to mercury vapors has been known to cause profound central nervous system effects. In children, the vapors have been known to cause neurological and kidney dysfunction.

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