The American Society of
Aesthetic Plastic Surgery has sent an
alert to all of its members in regard
to “PIP”, “Rofill”, and “M” implants.
PIP implants were manufactured
in France and Rofill implants were
manufactured in the Netherlands.
M implants, were manufactured in
both France and Germany. All of
these silicone gel implants have
been used throughout Europe and
South America. It is safe to assume
that they have been used in Central
America and other countries
where there is a high volume of
cosmetic breast surgery. One can
also assume that they may have
been used in the United States,
despite the fact that they were
never approved for implantation
here. The affected implants are
PIP , Rofill and M silicone breast
implants that have been used since
2001. There is a strong suspicion
that these implants manufactured
before 2001 may also be affected.
It is important to note that these
implants were never approved by
the Food and Drug Administration
in the United States. Many women,
however, have traveled abroad for
plastic surgery and are currently
living in the US with these implants.
The manufacturers of PIP, Rofill
and M breast implants used
inferior, industrial grade silicone
inside the implants they produced
and sold. Industrial grade silicone
is a gel that is specifically not to be
used in medical practice. It is not
known what impurities may exist
in this silicone and what damaging
effects these impurities can cause
in the human body. The silicone gel
implants that are FDA approved in
the United States are made with a
cohesive medical grade silicone
gel that is far superior and has
been tested and proven to be safe
for human implantation.
In addition, the PIP, Rofill and
M implants have a much higher
rate of rupture, according to
French reports as high as 11%
per year in comparison to the
silicone breast implants approved
in the US , which have a rupture
rate of approximately 1% per
year. The initial recommendation
for replacement of PIP, Rofill
and M implants came from the
French government regardless
of symptoms of rupture or
leakage. The American Society of
Aesthetic Plastic Surgery and The
International Society of Aesthetic
Plastic Surgery have recommended
that these implants be replaced.
Women who have had silicone
breast implant surgery
in Europe, Central or
South America, and
feel they may have
these implants should
consult their medical
records, implant ID
card, or surgeon’s
office to confirm that
in fact, they have the
affected implants. If so,
they should contact a
Board Certified Plastic
Surgeon for consultation
and replacement of implants as soon as possible.