A new research conducted by British doctors suggests that the rate of failure of PIP silicone breast implants could be up to 33.8 percent, which is significantly higher than the 2 percent to 5 percent failure rates usually reported by previous studies.
Under the new study, researchers examined patients who had PIP implants for primary/secondary breast augmentation from January 2000 to August 2005 in order to determine the rate of failure and other complications. The study found that PIP implants’ failure rate could range from 15.9 percent to 33.8 percent.
Most of the earlier researches typically used clinical examination and were based on multiple technique, multiple surgeon, with small number of study participants and shorter follow up time period. with the new study, all patients were scanned with ultrasound, providing conclusive sign of rupture, said lead authors Miles Berry and Jan Stanek, whose work appeared in the Journal of Plastic, Reconstructive and Aesthetic Surgery.
PIP silicone implants were formally recalled in the UK market two years ago due to concerns on its durability. There have been also concerns on the filler gel and outer cover of the breast implant called elastomer.
For the new study, plastic surgeons used PIP implants for secondary and primary breast augmentation. They then created a database of patients, who were offered a consultation for free and referral for ultrasound scan. Among the major outcome measures were implant rupture rate, time to rupture and secondary surgery.
The researchers identified 453 patients with PIP implants, 30 of whom had already gone through implant exchange. One hundred eighty patients or 39.7 percent could not be reached and 19 had gone through implant removal. Forty-seven of the patients who were contacted refused consultation for they didn’t have any concern. Ninety-seven patients had neither radiographic evidence nor clinical signs of rupture and chose to stay under regular review, while 38 had gone through implant exchange following ultrasonographic sign of rupture.
Given that those who could not be contacted had no ruptures, the overall rate of rupture would stand at 15.9 percent. But if they had the same rate of rupture as the patients examined in the research, the overall rate would reach 33.8 percent.
With these findings, researchers suggest that all PIP silicone breast implants may have to be removed due to the high rate of rupture and the uncertainty on the nature of the gel. Implants among patients with rupture will have to be removed, while those without evidence of rupture will have to be monitored regularly. on the nature of the gel filler and elastomer, further study may still be needed to determine if there is a need to explant all PIP implants in the future.
This initial research is just the tip of the iceberg that may affect 40,000 women with PIP breast silicone implants in the UK. More than 400,000 women worldwide are estimated to have received PIP implants.