Another Risk of Surgical Tourism: Foreign Breast Implants

    NEW YORK, NY, August 05, 2010 /24-7PressRelease/ -- Cosmetic surgery tourism has been increasing in popularity for many years. With the continuing demand for cosmetic surgery procedures, especially breast augmentation, many people who want the procedure find they cannot afford them. So they look for a way to get the same procedure for less. Many find that if they simply combine their procedure with a vacation to an exotic locale, they can get both the vacation and the surgery for less than they could get the surgery alone here.

The powerful incentive of cost has been driving the market for cosmetic surgery tourism, despite the continued cautions of surgeons in countries from which the tourists come, including the US and the UK. It is important to remember that if a procedure is cheaper someplace else, there is probably a reason for the price difference. Some of these reasons are benign, such as exchange rates or a lower local demand for a procedure. Other reasons may increase your risk of complications, such as lower standards for training and practice of surgeons or lower material standards. Plastic surgeons in this country commonly focus on the former, but the latter is also a source of concern.

Breast Implant Standards

In the United States there are currently only two brands of breast implants that have received FDA approval as being safe and effective for use in cosmetic breast augmentation: Natrelle (owned by Allergan, the maker of BOTOX Cosmetic) and Mentor. These implants have undergone rigorous testing and evaluation before their manufacturers were allowed to market them. This standard is even higher when considering silicone breast implants. As a result of the silicone breast implant scare in the 1990s that led to the temporary ban on silicone implants for cosmetic breast augmentation, silicone breast implants have been thoroughly scrutinized by the US Food and Drug Administration (FDA). Concerns over the potential link between silicone and autoimmune disorders, connective tissue disorders, and breast cancer led developers to work hard to maximize the robustness of their product and minimize bleed of silicone from the implants.

The Case of Poly Implant Prosthese (PIP)

Poly Implant Prosthese (PIP) is a French breast implant manufacturer. Although some of its implants have been used in the US for breast reconstruction, they are not approved for breast augmentation. In 2000, the FDA sent a cautionary letter to the manufacturer, saying that there were several problems with its manufacturing process, mostly that there was a lack of procedures for quality control, design control, and change control in the company.

The PIP implants have long had a reputation as being of a lower quality than other breast implants, but the company exported its product to 66 countries, and were considered one of the most popular implants in the UK. Then in early 2010, studies revealed that the implants may be twice as likely to rupture as other implants. In addition, it was discovered that the type of silicone gel used in the implants was not the type the company had said it would use, prompting a recall of all unused PIP implants, and prompting the reorganization of the company under government control.

Since the recall, research by the French Society of Plastic, Reconstructive, and Aesthetic Surgery (SOFCPRE) has revealed that the company had long manufactured defective implants. In its investigation, SOFCPRE found that PIP had done away with a secondary protective barrier in 2005. This barrier was intended to prevent the leak of silicone into the body, either through migration or rupture. PIP had also switched the type of silicone gel it was using, without informing regulatory agencies of the change. When SOFCPRE contacted the gel manufacturer for biocompatibility studies, it found there were no such studies because the manufacturer said it believed the gel was to be used in making mattresses.

Although imperfect, the FDA system does serve to protect US patients from some types of defective medical equipment (such as the PIP breast implants), and is another good reason why patients should think twice about cosmetic surgery tourism. To learn more about breast implant procedures, please visit the website of New York plastic surgeon Dr. George Lefkovits today at www.drlefkovits.com.

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