Silicone implants
In March 2010, Poly Implant Prothèse (PIP) silicone implants
were withdrawn from the European Union (EU) market following an observed
increase in implant ruptures, and confirmation of the use of
substandard silicone in the manufacture of the implants by French
regulator AFSSAPS (Agence Française de Sécurité Sanitaire des Produits
de Santé). Regulatory authorities in other jurisdictions were also
notified, leading to product withdrawal from a number of non-EU
countries. PIP implants have also been sold under the trade name of
M-Implants and in April 2010 the Dutch Health Care Inspectorate
prohibited all trade and usage of both products in the Netherlands.
On 23 December 2011, the French authorities published a
recommendation that French residents with PIP breast implants should
consider having these removed as a preventive measure. Following this,
other national health authorities have issued their own recommendations
that have ranged from preventive removal of PIP silicone breast
implants, to close monitoring and follow up of persons with these
implants.
Adverse events of approved breast implants include implant
rupture and leakage. While the rupture rate of PIP prostheses was
observed to be higher than expected in France, rates reported by other
national authorities vary.
Testing of PIP implants carried out by AFSSAPS found that the
quality of implants varied, therefore increasing the risk of rupture.
AFSSAPS also found that the gel containing non-approved silicone was an
irritant to tissue, and when leaking could give rise to inflammation and
pain.
More information is needed about the risks associated with
these implants and how they compare with other implants on the market,
and on product distribution, use and surveillance.
PIP and M-Implants silicone breast prostheses have been
distributed to many countries around the world. Both standard and
substandard silicone has been used to produce PIP implants.
Persons with PIP or M-Implant prostheses should consult their
doctor or surgeon if they suspect rupture, have pain or inflammation or
any other concerns. Affected persons and physicians should take note of
their national health authority recommendations and act accordingly. It
is, furthermore, important to consider strengthening adverse event
reporting of medical devices.
Source : http://www.who.int/csr/don/2012_01_17/en/index.html
