Will Faulty French Breast Implants Affect Medical Tourism?
Medical tourism to Asian and Latin American countries continued to increase in 2011. Will the recent French breast implant scare affect this trend in 2012? Here, we look at some important safety concerns that have been raised after it was revealed that a French company manufactured breast implants that were made with industrial-grade silicone.
Last month, the Korea Tourism Organization (KTO) reported that South Korea's medical tourism income reached a record high in 2011, accounting for $116 million of the country's revenue. About a third of those 120,000 foreigners were Americans who were seeking lower prices for plastic surgery procedures such as breast augmentation and tummy tucks. The KTO projects that medical tourism will continue to increase this year; they are expecting 150,000 medical tourists in 2012.
Meanwhile, construction on the $19 million Bosque Beauty Garden Hotel & Medical Center in Bogota is set to begin in March. The center will offer cosmetic surgery services and cater to the reported growing number of medical tourists in Colombia.
In Costa Rica, officials continue to invest in equipment, technology, hospitals, and medical-staff training. The Council for the International Promotion of Costa Rica Medicine is even working to attract the attention of American companies with the affordability of their medical care; the council wants these companies to offer travel surgery benefits to employees that travel to Costa Rica for medical treatments.
While authorities in these popular medical tourism destinations are confident they will see an increasing number of foreign patients in coming years, the flood of negative news reports regarding the faulty silicone breast implants that were manufactured in France has piqued concern and raised an important question.
Is traveling overseas for plastic surgery safe?
Do Your Research
Going abroad for plastic surgery can be safe. But patients must engage in research before making the decision to undergo treatment in a foreign country. You should be aware of the medical standards of the country to which you will be traveling, and verify your surgeon's credentials before committing to any travel plans.
Medical Product Approval
Each country has a different process by which they approve medical devices. In the United States, the Food and Drug Agency has the authority to deny, recall, or approve medical products for the domestic market. The FDA is known as one of the, if not the, strictest medical regulatory agencies in the world.
This point was evidenced by the French breast implant scare that has up to an estimated 300,000 women worldwide worried about their health; the defective silicone breast implants were never approved for use in the United States, but they were used throughout Western Europe and Latin America, where medical requirements are less stringent.
The AFSSAPS, which is the French equivalent of the FDA, pulled Poly Implant Prothese (PIP) silicone breast implants off of the market in March of 2010 after it was discovered that the company was using a homemade silicone filler that contained industrial-grade silicone instead of medical-grade silicone. Authorities have determined that the inferior filler material makes the implants more prone to leaks, and results in inflammation to surrounding tissue once the implant tears. Further, some medical experts worry that the industrial silicone could increase the risk of cancer, though not enough evidence has been found to support this claim.
PIP was able to sell its saline breast implants in the United States from 1996 up until 2000, when the company's application for approval was rejected. The French company applied for U.S. approval of their saline implant products in 2000, after the FDA required all breast implant makers to submit a pre-market approval application; this move came in response to concerns over breast implant infections and ruptures, and the application was required of any company that wanted to continue selling breast implant products in the United States. U.S. regulators rejected PIP's application due to quality control problems and failure to report complaints about their products. When silicone breast implants were re-approved for use in the United States in 2006, two companies received FDA approval for their silicone breast implants: Allergan, Inc. and Mentor® Corporation.
While most patients traveling abroad for plastic surgery educate themselves about the experience of their chosen surgeon, few consider the safety of the product that is permanently placed in the body. It is in your best interest to research the safety record of the medical products that may be used for your surgery, especially if the FDA has yet to approve the device.
The surgical facility accreditation process also varies by country. In the United States, we have the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF), which has established a set of sterilization and safety regulations. AAAASF-approved facilities must undergo an inspection process and peer review program, both of which are designed to ensure that participants adhere to the highest possible medical standards.
If you're considering going overseas for treatment, find out what type of accreditation is offered. Review the standards of care and make sure that a trusted authority currently accredits your surgeon.
Board certification is the gold standard by which we measure physicians in the United States. The American Board of Medical Specialties (ABMS) has established a rigorous review process that allows the member board to evaluate physician competence within a specific area of medicine. Physicians must renew their board certification every six to 10 years to ensure that they are educated on the latest advances in the field. Board certified plastic surgeons are considered the best choice for patients that are undergoing cosmetic surgery, as these surgeons have already demonstrated their ability and commitment to the ABMS.
Does the country that you plan on traveling to for plastic surgery offer the equivalent of a board certification process? Do they have an established system in place to evaluate surgeons on a periodic basis? Which agency is advocating for the highest level of patient safety and care? Educating yourself about the answers to these questions is important for any patient that is seriously considering medical tourism.
Despite the bad press regarding the defective French breast implants, the tourism boards in South Korea, Colombia, and Costa Rica remain optimistic about the future of medical tourism. Whether it diminishes the American appetite for cheap plastic surgery or not, it is a reminder that medical tourists should thoroughly research their options before making the decision to go overseas for plastic surgery.
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