I can understand where many of you in this discussion are coming from, however I am going to have to respectably disagree. Although it is the responsibility of the company to ensure that they have minimized the residual risk of their product as far as possible, it is the patient’s responsibility to understand the residual risk of the product they are using. As Irene stated as long as the residual risk of the product has been assessed by the FDA and given approval the product will go on market with the risks described in the labels. At this point it is the sole responsibility of the patient to understand this risk and decide if the benefits obtained by this product outweigh this risk.