Investigative Documentary ABSOLUTELY SAFE Challenges Safety of Breast Implants as Whistle-blowers Question the FDA

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Every year, more and more women and teenagers in the U.S. are choosing to receive breast implants. ABSOLUTELY SAFE follows the real-life stories of two young women, Deneé and Wendi, as they face their own body image issues and the medical choices surrounding this popular plastic surgery procedure. This timely documentary exposé comes out on the heels of a recent letter to congress from a group of FDA scientists that accuses top FDA officials of engaging in "serious misconduct" by tampering with the approval process of medical devices. Breast implants are classified as medical devices.

her feel more like a woman.

Every year, more and more women and teenagers in the U.S. are choosing to receive breast implants. ABSOLUTELY SAFE follows the real-life stories of two young women, Denée and Wendi, as they face their own body image issues and the medical choices surrounding this popular plastic surgery procedure. But it is the story of Audrey Ciancutti that is the true catalyst for the making of this documentary exposé. In 1974, Audrey was diagnosed with breast tumors and underwent a double mastectomy followed by breast reconstruction with silicone implants. When the implants ruptured a year later, Audrey's health began a steady and mysterious decline. Her doctor replaced the ruptured silicone implants with new ones, yet no one asked "are they safe?" until her daughter began to question the potential link between her mother's failing health and the timing of the leaking implants. Concerned daughter turned filmmaker-activist Carol Ciancutti-Leyva documents her mother's quest for answers, and these younger women's struggle for peace with their own bodies, exposing enormous questions around the multibillion-dollar business of breast implants.

  •      Members of the media may access embeddable clips, complete film information and downloadable stills at: Absolutely Safe Press Page. To request a DVD screener please email: juliapacetti@earthlink.net

The American Society of Plastic Surgeons reports that last year nearly 400,000 women in the U.S. received breast implants. Yet amidst this booming industry lies a complex story of questionable regulation and research, health risks, and women determined to do anything to have the "perfect" breasts. Do women considering implants know about the risks? Are manufacturers and the medical community providing women with all of the facts necessary in order to provide "informed consent?" Today, this procedure has become so popular that high school teenagers receive implants as graduation presents, however few consumers, physicians or regulators are asking whether these medical devices are as safe as the FDA purports them to be. In fact, on November 17th, the New York Times published an article reporting on a letter to congress from a group of FDA scientists accusing top FDA officials of engaging in "serious misconduct" by tampering with the approval process of medical devices. Breast implants are classified as medical devices.

ABSOLUTELY SAFE is a daring investigation of the controversy surrounding breast implant safety featuring the stories of every-day women - from breast cancer survivors to young women simply dissatisfied with their appearance. They each chose breast implant procedures for different reasons, but they all have one thing in common: they all believed the implants to be "absolutely safe." Featuring interviews with plastic surgeons, FDA regulators and outspoken scientists, ABSOLUTELY SAFE documents the labyrinthine FDA approval process for silicone breast implants and investigates the influence of pop culture on societal ideals of beauty.

A GUIDE TO THE FILM

ABSOLUTELY SAFE is set around the stories of three women. The first is Audrey, who received breast implants after a double mastectomy in 1974. The next are two young women who make opposite choices: Deneé who is getting breast implants, and Wendi who is having her implants removed.

Audrey - Like thousands of other women, Audrey Ciancutti believes her debilitating symptoms, including joint pain, chronic fatigue and scleroderma, are linked to her breast implants. However, most doctors and researchers deny this link. Like many of her peers, Audrey says she was not offered the proper information to make an informed decision about implants, and was simply told they were "absolutely safe." Audrey advocates for implant safety regulation and testifies before an FDA panel stating, "I have no conflicts of interest."

Deneé - 27-year-old Deneé is determined to have breast implants and does not worry much about their risk. She envies pop culture icons, like Jessica Simpson, with large breasts and says she has always been insecure about her own breast size. Against her husband's wishes, and despite his appreciation of her natural breasts, Deneé proceeds with her breast augmentation and becomes the "Full C" she's longed to be. She says they make "her feel more like a woman."

Wendi - A young woman from Texas, Wendi has spent years longing for a life without implants. After suffering unexplained illnesses for years, including dizziness, hair loss and fatigue, Wendi firmly believes that her silicone implants are ruptured and are making her sick, even though (from the outside) they appear to be intact. With the financial help from her mother and the surgical skill of Dr. Edward Melmed, one of the few plastic surgeons in this country who argues that implants have severe flaws and cause illness in some women, Wendi chooses to have her breast implants removed from her body forever. The remnants of Wendi's implants are documented post-surgery and provide a graphic discovery.

This controversial documentary includes every-day women like Audrey, Deneé and Wendi in the debate about breast implant safety along with plastic surgeons, toxicologists, attorneys, implant manufacturers, government officials and activists who each state their case.

ABOUT ALIVE MIND

Alive Mind releases specialty documentary programming in the areas of women's issues, new consciousness and cultural transformation on DVD and via digital download. Alive Mind was launched by industry pioneer Richard Lorber as a specialty distribution arm of his new company, Lorber HT Digital. The company seeks to provide its audience with intellectually provocative work from leading filmmakers that delivers the "aha" response of a transformative experience. AliveMindWoman.com is especially committed to offering unique films that examine and express the vast array of issues facing women today. The first DVD's released as part of this special programming strand include Flying: Confessions of a free woman by acclaimed filmmaker Jennifer Fox; the classic "goddess trilogy" Women & Spirituality; and Beyond Belief, the 9/11 widow's journey featured on Oprah. In support of continued exploration of the women's issues related to our films, AliveMindWoman.com hosts blogs for some of today's most stimulating thinkers and activists including Carol Ciancutti-Leyva, Ariel Gore, Beth Murphy and Jennifer Fox. To advance the discussion, visit us online at AliveMindWoman.com.

ABSOLUTELY SAFE: DVD

Street Date: January 13, 2009
Suggested Retail Price: $24.98 (DVD)
Genre: Documentary
Region: NTSC Region 0
Production Year: 2008
Rated: NR
Feature run time: 83 minutes
DVD aspect ratio: 16:9
Audio: Dolby Digital
Languages: English
Purchase Online: AliveMindWoman.com

Media contact/screener requests: Julia Panely-Pacetti juliapacetti(at)earthlink.net, (917) 584-7846

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Alive Mind
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