Exciting news in the world of breast augmentation as Health Day News reports a new, silicone-gel breast implant has received conditional approval from the U.S. Food and Drug Administration. This new implant is designed to be used for breast augmentation in women 22 and older, as well as for breast tissue reconstruction at any age.
One of the top procedures Orbicare’s medical travel clients undergo is often breast augmentation, whether elective or needed for reconstruction due to an illness. Our skilled surgeons and medical professionals at our facilities in South America and Spain continue to rank as at the top in regards to the safety of procedures and client recovery.
Dr. William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health said, “Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness.”
Silicone gel implants were once banned in the United States for 14 years, until 2006 when the FDA approved the ones made by Allergan and Mentor for breast reconstructive surgery and for breast enlargement in women 22 and older. When the ban was lifted, the FDA noted that there was not sufficient data on adverse effects, including what the agency called “rare events” and “long-term performance.” The agency then required the manufacturers to do studies on the implants’ safety and performance after their approval.
After a two-day hearing last September, the FDA ruled that silicone implants were safe and could remain on the market. The agency said that it would work with manufacturers of the devices approved for use to improve studies gauging the health of women who received the implants.
For inquiries regarding breast augmentation or reconstruction, please visit Orbicare’s website at www.orbicare.net or call us toll free at (888) 398-1355. One of our highly-trained professionals will happily answer any questions you may have and get you on your way to enjoying all of the benefits as one of our medical tourism clients.
Health Travel Specialist 