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July 13, 2011
  FDA Warns of Surgical Mesh Complications
Posted By DeCarli Law
The FDA issued an alert today about complications that can arise from transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Over the past three years, the FDA has received over 1,000 reports of complications when surgical mesh was used in these procedures.

Surgical mesh is used to provide a reinforcing structure in various surgical procedures. The FDA alert said the complications had been associated with surgical mesh from all nine manufacturers of the product.

According to the FDA's alert, the most common complications are erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. In the worst cases, vaginal scarring and mesh erosion led to a significant decrease in the women's quality of life due to discomfort and pain, including dyspareunia (pain during sexual intercourse).

You may read the entire FDA safety alert HERE.

Continue reading "FDA Warns of Surgical Mesh Complications" »
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April 28, 2011
  FDA Proposes Studies on How Drug Maker Websites Influence Consumers
Posted By DeCarli Law
The FDA has proposed three studies to test how consumers react to promotional websites for prescription drugs based on the content and format of the website.  The FDA published its proposal on April 28, 2011, and is seeking public comment.

The proposal explains that FDA regulations require that advertisements for prescription drugs “include a ‘fair balance’ of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information.”  The concern is that the old rules governing drug advertisements for print media are not adequately crafted to insure that online advertising discloses the potential risks from the drugs promoted online.

As an initial step toward creating new rules, the proposed studies seek to determine how website content and organization impact consumers’ understanding of the risks associated with prescription drugs.  For example, one study will test consumers’ comprehension of drug risks based on how many clicks away from the home page risk information is located.  It also will compare consumer comprehension of bulleted lists vs. paragraph text.  Another study will scrutinize the use of personal testimonial videos.

The FDA will be accepting public comment on the proposed studies for the next 60 days.  A complete copy of the FDA proposal may be found HERE.
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DeCarli Law represents drug side effects and defective medical devices personal injury clients for claims, lawsuits and settlements in Alabama AL, Alaska AK, Arizona AZ, Arkansas AR, California CA, Colorado CO, Connecticut CT, Delaware DE, Georgia GA, Hawaii HI, Idaho ID, Illinois IL, Kansas KS, Maine ME, Maryland MD, Massachusetts MS, Minnesota MN, Mississippi MS, Montana MT, Nebraska NE, New Hampshire NH, New Jersey NJ, New Mexico NM, New York NY, North Carolina NC, North Dakota ND, Oklahoma OK, Oregon OR, Rhode Island RI, South Carolina SC, South Dakota SD, Tennessee TN, Utah UT, Vermont VT, Virginia VA, Washington WA, Washington D.C, West Virginia WV, Wisconsin WI and Wyoming WY. The attorneys of DeCarli Law are licensed in California and Texas. DeCarli Law's practice includes lawsuits for Propecia side effects, Finasteride lawsuits, Topamax lawsuits, Fosamax lawsuits, Gadolinium lawsuits, NSF lawsuits, Nephrogenic Systemic Fibrosis Lawsuits, YAZ lawsuits, Yasmin lawsuits, Ocella lawsuits, and Zarah lawsuits.