PIP breast implant failures significantly higher than thought
20 April 2012
The failure rate of silicone breast implants manufactured by
Poly Implant Prosthèse (PIP) could be as high as 33.8%, according to new
research published in the Journal of Plastic, Reconstructive and
Patients who received PIP implants either for primary or secondary
breast augmentation, between January 2000 and August 2005, were
studied to determine implant failure rate and other complications.
Results found that 7 to 12 years after implantation the failure rate
for PIP implants is in the region of 15.9-33.8%.
Concerns about the durability of PIP silicone breast implants have
been expressed for several years prior to their formal withdrawal
from the UK market in March 2010. Although precise details of what
elements were at fault remain unclear, concerns have been raised
about both the elastomer (the outer cover of the implant) and the
"Previous studies have typically reported failure rates of between
2% and 5% and these estimates have been based on secondary data. In
this study, all participants were scanned by ultrasound, which
provides conclusive indication of rupture, rather than clinical
examination which is typically used. Most previous studies were
based on multiple surgeon, multiple technique, with a relatively
small number of patients and shorter follow up time span," commented
Mr. Jan Stanek, lead author of the study.
In this study PIP implants were used by the plastic surgeon for both
primary and secondary breast augmentation. A database of patients
was constructed and each patient was offered a free consultation and
referral for ultrasound scan. Chief outcome measures included
secondary surgery, implant rupture rate and time to rupture.
453 patients with PIP devices were identified. Of this number, 30
had already undergone implant exchange for a variety of reasons. 180
(39.7%) could not be contacted and 19 had undergone implant removal
elsewhere. Of those who could be contacted, 47 declined consultation
as they had no concerns. 97 had neither clinical signs nor
radiographic evidence of implant rupture and elected to remain under
regular review. At the time of writing, 38 had undergone implant
exchange after ultrasonographic indication of rupture.
Based on these results, if the group of non-responders had no
ruptures, the overall rupture rate would be 15.9%. However, it the
non-responders had the same rupture rate as those examined in the
study, the overall rupture rate would be 33.8%.
Mr Stanek indicates that all PIP implants, due to the high rupture
rate and uncertainty about the nature of the silicone gel, may need
to be removed. Those patients with ruptured implants will have to
have them removed; 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 explanted in the future.
M.G. Berry and Jan J. Stanek. The PIP mammary prosthesis: A product
recall study. (DOI: 10.1016/j.bjps.2012.02.019); in press, ahead of
print in Journal of Plastic, Reconstructive and Aesthetic Surgery,
published by Elsevier.