But despite their designations, the data produced by the companies themselves and the independent research of scholars document problems with implants that patients should consider seriously before committing to what may be years of medical management. The federal regulations require information on side effects, contraindications, and effectiveness, and forbid the use of false, misleading, or confusing information in any part of the advertisement. They preclude any suggestion or representation that the drug is safer or has a lower incidence of or less serious side effects than demonstrated by clinical evidence. This suggestion is unlikely to be welcomed by anyone. The FDA sees itself as fulfilling its role in assuring safe and effective devices and supervising the informed consent materials.
Companies see their right to increase market share with clever materials.
Women see their right to choose surgical interventions that enhance their sense of body image and self-worth. All are correct. The original idea of the informed consent process presupposed a physician whose primary focus was the welfare and the best interest of the patient. Many physicians continue to adhere to these values, but some stand at the boundary between patient interest and market share. For these, and for the products they use, merely informing is too passive a process.