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Recent Blog Posts in January 2011 |
| January 27, 2011 |
| Anaplastic Large Cell Lymphoma (ALCL) Linked to Breast Implants |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration announced yesterday a possible association between saline and silicone gel-filled breast implants, and anaplastic large cell lymphoma (ALCL). Data suggests that patients with breast implants have a very small, but significant, risk of ALCL in the scar capsule adjacent to the implant.
ALCL is a relatively uncommon type of non-Hodgkin’s lymphoma that arises from T-cells. ALCL is diagnosed in about 1 out of 500,000 women in the United States each year. ALCL located in breast tissue is even less common. The FDA is aware of only about 60 cases of ALCL worldwide in women with breast implants. However, the exact number is uncertain because it is likely that not all cases have been reported.
At present, breast implant manufacturers do not warn of the risk of ALCL. However, in an effort to ensure that patients receiving breast implants are informed of this risk, the FDA will be working with manufacturers in the coming months to update their product labeling materials to add a warning.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE
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| January 24, 2011 |
| General Electric Settles NSF Case on the Eve of Trial |
| Posted By DeCarli Law |
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At the last minute, General Electric settled a case brought by a plaintiff suffering from Nephrogenic Systemic Fibrosis (NSF). Trial was scheduled to begin today in U.S. District Court in Cleveland, Ohio, and would have been the first
NSF case to go to trial. A settlement was reached late Sunday night.
The plaintiff developed NSF in 2005, after receiving several scans during the previous two years using
Omniscan, GE’s brand of
gadolinium-based contrast agent.
Omniscan has caused more people to develop NSF than any other
gadolinium-based contrast agent.
NSF, also known as
nephrogenic fibrosing dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD is the use of
gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
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| January 12, 2011 |
| Drug Companies Hide Side Effects From Investors As Well As Consumers |
| Posted By DeCarli Law |
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From our work representing people injured by dangerous drugs, we’ve learned the hard way that drug companies often conceal drug side effects from consumers. According to a lawsuit now on appeal to the Supreme Court of the United States, they also sometimes hide them from their own investors, which underscores the importance of reporting drug side effects to the FDA.
A posting on the Wall Street Journal’s Law Blog reports on a lawsuit filed by investors against Matrixx Initiatives, Inc., whose wholly-owned subsidiary manufacturers Zicam. Investors brought a securities-fraud class-action lawsuit against Matrixx. The lawsuit alleges the company failed to disclose reports from consumers that they lost their sense of smell after using Zicam Cold Remedy nasal gel and swabs. Matrixx received at least a dozen reports between 1999 and 2003, but did not disclose this to potential investors.
The fact that pharmaceutical companies do not disclose reports of drug side effects to their own investors, as well as to the consumers who use their products, reinforces the importance of reporting injuries to the FDA. If you experience a side effect after using a prescription or over-the-counter drug, you should immediately report it to your physician and to the drug manufacturer, but ALSO report it to the FDA. You can easily do this online HERE.
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