KENNESAW, GA -- January 18, 2012 -- Women concerned about the recent health scares over the controversial PIP breast implants in Europe can rest assured that the silicone Amoena (www.amoena.com) uses to manufacture its externally worn prostheses does not pose similar health dangers.
The company issues the statement in response to the current accusations that Poly Implant Prothese (PIP) used industrial-grade silicone in some of its implants, which could cause health problems if they burst or leak. An estimated 300,000 women have been affected worldwide.
The French government has urged women in France with PIP implants to have them removed—and offered to pay for the surgery. Other countries, including Britain, are encouraging women to visit their surgeons for checks. The Food and Drug Administration prohibits PIP from selling its saline implants in the United States. Amoena, the world-leading manufacturer of prosthetic breast forms, produces silicone breast forms, which women wear in the cup of a bra to replace the breast that was removed during breast cancer surgery. The prosthetic breast helps restore their appearance and provides the balance that helps prevent postural problems. Women wearing external prosthesis are not at risk of health complications caused by silicone.
“For women who have suffered the trauma of a breast cancer diagnosis, and who do not want to undergo further surgery, we are pleased to be able to provide a solution that is safe and of the very highest quality. It’s a reassuring and realistic solution at what is undoubtedly a very stressful time in any woman’s life,” says Helmut Wild, vice president of research and development at Amoena.
Quality Assurance
In 1992, Amoena was the first breast prosthesis manufacturer in the world to set up a certified quality management system that conformed to BS5750/2, the internationally recognized quality standard at the time.
“Today’s standard for medical device manufacturing is ISO13485, equivalent to the FDA QSR (Quality System Regulation), and Amoena’s rigorous quality management process ensures that we remain fully compliant today,” says Wild. “Each Amoena breast form is classified as a medical device, and this classification requires biocompatibility testing according to international standards.”
Amoena conducts biocompatibility testing to assure that materials coming in contact with the skin are completely safe, non-toxic and non-irritant.
“Only the very best materials are considered after passing our extensive testing in production conditions and fulfilling all biocompatibility requirements. Amoena has the widest experience in producing silicone breast forms, the highest number of product and process patents and we have developed our own bespoke production technology that ensures rigorous end-to-end quality control,” Wild explains.
Amoena invented the externally worn silicone breast form in 1975, revolutionizing the level of post-operative care that was offered to women following breast cancer surgery.
“We have dedicated ourselves to research and development working closely with medical specialists and women who have undergone surgery to ensure that we incorporate the latest technology into our pioneering designs. The result is innovative breast forms of the highest quality,” says Wild.
One of these innovations offers women a realistic alternative to breast reconstruction. The Amoena Contact breast form adheres directly to a woman’s chest wall and stays securely in place all day long.
“Our Contact form looks and feels just like a real breast,” says Wild. “It offers women the freedom of movement and the choice in clothes and lingerie that they had before surgery. We’ve had feedback from thousands of delighted customers, telling us that it has quite literally changed their lives.”
Over the decades Amoena has established manufacturing processes that produce the most durable, skin-friendly, lifelike breast forms in the industry.
“For a woman who is anxious to move forward after breast cancer, our breast forms are the closest thing to a real breast. And our state-of-the-art manufacturing plant and patented processes ensure that her safety is paramount and her peace of mind is assured,” says Wild.
To learn more about Amoena, visit www.amoena.com.
About Amoena
For 35 years, Amoena has helped millions of women enjoy fuller lives by providing the highest quality post-breast surgery products to for women. In addition, Amoena works with its retail partners to negotiate with health insurance plans to appropriately reimburse breast forms and supplies. For more information, visit www.amoena.us or call 800-926-6362.
Contacts:
Amoena USA Corporation
www.amoena.us
Lee Thrash:
Tel. 770-281-8300
lee.thrash@amoena.com