Regulatory Focus™ > News Articles > Lancet: US FDAs Approach to Silicone-Gel Regulation a Model for Others

Lancet: US FDAs Approach to Silicone-Gel Regulation a Model for Others

Posted 17 January 2012 | By Alexander Gaffney, RAC 

An editorial in the British medical journalThe Lancet is calling further attention to the Poly Implant Prothese (PIP) scandal, highlighting the successes of the US Food and Drug Administration (FDA) in keeping the US public insulated from the dangers affecting Europe.

"There are valuable lessons to learn from countries that have experienced their own regulatory crises," writes The Lancet's editorial board. The US is a country that has "been spared that silicone breast implant scandal" thanks to regulatory vigilance and a regulatory system that has placed a significant emphasis on safety.

While silicone-gel implants are now common in the US-some 200,000 women received them in 2011 alone-they were banned from cosmetic use between 1992 and 2006 after FDA determined that insufficient data existed to assure their safety. The use of silicone-gel implants was allowed during that time frame for use in reconstructive medical procedures.

By 2006, numerous reports investigating the purported link between silicone-gel implants and system disease failed to link the two together, and the ban was lifted. A follow-up by FDA in 2010 further established their safety, but noted local complications that women need to be made aware of before consenting to the procedure.

Two US suppliers-Allergan and Mentor-currently supply the entire US market for the cosmetic implant devices. Their approval from FDA was contingent on the two companies conducting postapproval studies of 40,000 women who received the device for a decade after it was implanted.

The Lancet notes that for all of the criticisms about FDA failing to approve devices quickly, this is an instance when its slow and measured approach has resulted in a benefit for consumer safety and confidence in the regulatory system.

The Lancet's editorial quotes former FDA Commissioner David Kessler, who said, "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."

The editorial goes on to say that FDA could stand to benefit from "ensuring that manufacturers complete postmarketing safety studies" and enforcing "a national registry of silicone-gel breast implant recipients."

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