USA: FDA considered Breast Implant complications, including rupture, to be acceptable risks in 2010 Print E-mail
But read Feminist Research on the subject
 Volume 379, Issue 9811, Page 93, 14 January 2012

Silicone breast implants: lessons from the USA

The Lancet [But read Feminist Research on the subject HERE]

The scandal engulfing the use of silicone-gel breast implants in the UK and across Europe might seem an isolated example of regulatory failure for an uncommon device. But breast implants are widely used, the cosmetic industry is growing, and there are valuable lessons to learn from countries that have experienced their own regulatory crises. The USA is one such country. Last year alone, silicone-gel implants were used in almost 150 000 American women for breast augmentation and in 46 000 women for breast reconstruction.

That particular types of silicone breast implants are safe was twice re-emphasised by the US Food and Drug Administration (FDA) in 2010. On Aug 31, after 2 days of public testimony among silicone implant manufacturers, surgeons, and the FDA, the FDA's chief scientist concluded that American women can consent with confidence to procedures involving silicone implants, which are considered safe but with an acceptable risk of local complications (rupture, tissue hardening, pain, inflammation, and infection). In June, 2010, the FDA published a 63-page report assuring safety of silicone-gel breast implants after examining preliminary data gathered since their approval in 2006. This report also emphasised that implants are not intended to last a lifetime, and that women will most likely require additional surgery.

Why has the US been spared the silicone breast implant scandal that is currently taking place in the UK, France, and elsewhere? The history of silicone-gel breast implant regulation in the USA has not been without its own turbulence and controversy. Such implants have been available to American women since the early 1960s, but not until 1976 did they come under the regulatory umbrella of the FDA by law. The FDA's decision then was to leave implants on the market pending approval. The 1980s brought anecdotal reports of women with certain systemic conditions (connective-tissue disease and cancer) that were allegedly associated with silicone implants. In 1988, the FDA classified silicone breast implants as devices that needed their safety and efficacy to be proven in order to stay on the market. Device manufacturers were given 30 months to provide the necessary data. In late 1991 and early 1992, two FDA panel meetings concluded that what information was available was insufficient to fully assess the risks. In April, 1992, FDA Commissioner David Kessler imposed a federal moratorium on the availability of silicone breast implants. They were only to be used for reconstructive (medical), and not elective, purposes until their safety was proven. The next 14 years was an era of divisive and acrimonious litigation (including the biggest US class-action lawsuit in 1995 of US$4·3 billion)­as well as publications in peer-reviewed journals and a 400-page Institute of Medicine report in 1999­all failing to link systemic disease with silicone breast implants. The ban on implants was lifted in 2006 and since then just two manufacturers, Mentor and Allergan, have supplied the US market. Part of the FDA's decision depended on manufacturers conducting large post-approval studies following 40 000 women for 10 years after receiving breast implant surgery.

A crucial question for regulators is the meaning of safety. How safe is safe enough? Was the clinical experience in 1 million women over 30 years in the USA insufficient for these devices to be proven safe in 1992? Kessler put it this way: “the role of the FDA is not to prove a device to be unsafe before it can protect against its use, but rather the US law states that safety first is to be demonstrated by manufacturers”. Since its 1992 moratorium, the FDA has implemented a much more conservative approach to regulatory approval, concentrating on safety. The FDA rightly sees itself as a protector of the American people. That said, the FDA needs to improve its record by ensuring that manufacturers complete post-marketing safety studies. The agency also needs to enforce a national registry of silicone-gel breast implant recipients.

Here are absolutely vital lessons to learn for governments, regulators, and the professions in Europe. It will be important for regulatory agencies to recall the setbacks and successes for silicone-gel breast implants in the USA. That debate continues for medical devices. Some critics argue that the FDA's approval process is too slow and bureaucratic. Unless it speeds up, the US will (these critics allege) lose the innovation race to overseas competitors. But at what cost to safety? Within this history one will discover solutions not only for the present scandal but also for the prevention of further crises in the future. Women should expect no less.