Since the early 1990s a public debate regarding the safety of breast implants has raged. The history of the controversy is a complex one, involving thousands of outspoken ill women, years of government hearings, FDA restrictions, Congressional mandates, major chemical and pharmaceutical companies, nation-wide litigation, lobbyists, lawyers, activist organizations, public relations firms, disputed data, competing scientists, and millions of dollars in court settlements. And yet, the controversy continues.

The heart of the breast implant controversy revolves around safety. A multitude of sick women who have breast implants and suffer from the same kinds of symptoms—chronic fatigue, muscle and joint pain, hair loss, dizziness, lupus, to name just a few, believe that their breast implants have caused their illnesses. Implant manufacturers, most doctors, most scientists, and the Institute of Medicine (IOM) refute these claims. Additionally, a multitude of women who have breast implants are happy with their choice and feel that their health has not been compromised.

As the voices of thousands of women who believed they were sick from their implants grew louder and more organized in the 1990s, the Food and Drug Administration (FDA) reviewed all existing safety data manufacturers had compiled on breast implants. In 1992, after breast implants had been on the market for nearly three decades, the FDA placed restrictions on the sale of silicone gel implants because the manufacturers could not provide sufficient safety data for FDA approval. Under these restrictions, reconstruction patients and only augmentation patients who participated in clinical trials could have silicone gel breast implants in the United States.

In 1999, Congress called on the Institute of Medicine (IOM) to conduct an independent review of all safety concerns and research data concerning breast implants. In its report, the IOM stated that there was not sufficient evidence to support the link between breast implants and systemic illness, including auto-immune diseases. That same year, the FDA approved the sale of saline implants which were marketed as an alternative to silicone gel implants.

In November 2006, after years lobbying by implant manufacturers for FDA approval, the FDA approved silicone gel implants made by both Mentor and Allergen Corporation (formerly Inamed). Today, any woman in the United States over twenty-two may receive silicone gel breast implants for breast augmentation. Women of all ages may receive silicone gel implants for breast reconstruction. However, the FDA advises all implant users to have regular MRI scans to check for breast implant rupture.

Despite the FDA’s decision to approve silicone gel implants, the controversy and concern over breast implant safety continues. Critics of the decision point to the data the FDA relied upon—short term research, following implant users for no more than four years, and studies largely paid for by implant manufacturers. Proponents of the decision declare that breast implants are one of the most studied products on the market and that women have the right to choose for themselves.

In ABSOLUTELY SAFE plastic surgeon Dr. Edward Melmed and occupational health physician Dr. Michael Harbut maintain that breast implants remain flawed and potentially dangerous. On the other hand, renowned plastic surgeon Dr. Franklin Rose, as well as most plastic surgeons, strongly believe that breast implants have been repeatedly proven as safe and effective.

The goal of ABSOLUTELY SAFE is to bring the controversy into focus, leaving viewers more informed and inspired to ask questions about implant safety, implant regulation, the rising popularity of implants, and the reasons why so many women make this choice.