Researchers at Surgical Aesthetics in London studied 453 patients who received PIP implants either for primary or secondary breast augmentation between January 2000 and August 2005. They found that seven to 12 years after implantation, the failure rate for PIP implants ranged between 16% and 34% (JPRAS, 9 March 2012, corrected proof).
Previous studies have reported failure rates of between 2% and 5%, but these estimates have been based on secondary data, wrote lead author Jan Stanek.
Stanek and colleagues suggested that, due to the high rupture rate and uncertainty about the nature of the silicone gel, all PIP implants may need to be removed. Women with ruptured implants will have to have them removed, while those with no evidence of rupture will need to be monitored on a regular basis.
Further research into the nature of the elastomer and gel filler will determine whether all PIP implants should be removed in the future, the researchers wrote.