Breast implants are one of the most researched medical devices in the industry. According to an online article United States health officials have tried repeatedly to establish a registry that would keep track of breast augmentation patients. Ideally the registry would compile information concerning complications over time including rupture and infection. Currently no such registry exists, although we have the largest healthcare market, which serves as a model for regulatory practices.
Some specific countries in Europe have made attempts but their attempts have been futile.After the alarming scandal that began with France’s PIP breast implant scare which resulted in the company using industrial grade silicone instead of medical grade silicone implants surgically implanted in over 300,000 women worldwide, a registry became the focus.
The French government advised that 30,000 breast implants be removed. Without a registry it is virtually impossible to know with certainly which women have been implanted with the tainted breast implants. “If we had had registries, we would have known years ago if it’s true that PIP implants break sooner,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We would have known if Mentor ones break sooner or later than Allergan’s,” she said, referring to the two largest makers of breast implants.
Close to 400,000 breast enlargement or breast reconstruction procedures were performed in the United States in 2010 according to the American Society of Plastic Surgeons. The FDA relies on company funded initiatives to track the safety of breast implants since allowing the silicone breast implants back on the market in 2006. The approval given to the largest breast implant manufacturers Allergan, and Johnson & Johnson Mentor unit was a conditional one based on the companies following 40,000 women who have received the implants for 10 years as well as extending smaller preapproval studies. Both companies failed to meet the conditions of the approval. Both companies addressed the low response rate by pointing out the cumbersome and time-consuming requirements for patients. Even with cash incentives patients were not compliant. The concept of one registry is a great idea but manufacturers say that it is complicated and virtually impossible.
Dr. Newen explains to each patient that breast augmentation is not without risk and complications. Although silicone implants are FDA approved patients are required to receive specific information concerning the implants and their risk and complications. Patients who choose silicone implants have been overwhelmingly pleased with their results. Dr. Newen offers both saline and silicone implants and patients who are considering breast augmentation are encouraged to contact image plastic surgery and schedule a consultation.
Posted in Plastic Surgery on March 11th, 2013 by Dr Peter Newen – Comments Off