Silicone gel breast implants were introduced to the U.S. market in the 1960s. In 1992, after reports that they leaked silicone into women's bodies and endangered their health, the FDA took the devices off the market and restricted the use of implants to clinical trials. During the next 14 years, women continued to get other kinds of breast implants. (Public Citizen estimates that 80 percent of the 300,000 implants done in the United States each year are for cosmetic reasons.)
Then, in fall 2006, the agency announced that the implants were "safe and effective," approving their use for breast augmentation in women 22 and older, and for breast reconstruction in women of any age. The makers were required to conduct a long-term (10-year) safety study on some 40,000 women. Prior to the lifting of the ban, the FDA had received a letter from a scientist, an ex- employee of one of the two companies later approved for implants, Mentor Corp. in which he accused the company of withholding data from the FDA about seepage and rupture problems. What ethical issues arise in this scenario?