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,
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
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
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.