Let’s take a closer look at one of the Davol patents, which provides the “blueprint” for the Kugel Mesh Hernia Prosthesis (Canadian Patent CA 2 357 020). A brief review of Davol’s patent shows that the oval shaped Kugel Patch is made from a mesh that will not dissolve, and that it has a flexible ring fastened around the edge of the oval mesh to give it shape. The ring material is supposed to dissolve (resorb) over time, leaving the flexible mesh in place to act as an abdominal wall support. Once in place, the mesh portion of the Kugel Patch adapts to the convex shape of the abdomen. (more…)

In the wake of the new Current Good Manufacturing Process (CGMP) the FDA has now posted “FDA 101 How to Use the Consumer Complaint System and Med Watch” to deal with the growing issue of unsafe and contaminated products that include dietary supplements. (more…)

Not necessarily. The herbal product industry is still a largely unregulated industry and historically we know that many of America’s Corporate Citizens have a hard time policing themselves. When those spreadsheets hit the boardroom tables in Big Corporations, it can be difficult for them to consider safety and not focus exclusively on profit margin, bottom line.

When you pick up an herbal drug, you may ask yourself just how much testing and safety analysis the product has undergone. Until the product causes a problem, no one may know for certain. If the problem does not reach the attention of the FDA or Trial Attorneys, consumers may suffer injury or death without discovery that it is the “natural herbal product” that is the culprit.

International Pharmaceuticals, Ltd. has agreed to recall a product called “Viril-Ity-Power (VIP) Tabs, but only after the FDA analyzed the product and advised International Pharmaceuticals that it could cause dangerous drops in blood pressure in some patients. Viril-Ity-Power was touted as a sexual enhancement in the same category as Viagra and similar, regulated drugs. Consumers with diabetes, high blood pressure high cholesterol, or heart disease often takes these types of products. Those consumers, of course, are at most risk with a side effect that dangerously lowers blood pressure.

Kudos to the FDA for their analysis and action to cause a recall.