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ISAPS has two missions: ongoing education of our
member surgeons and the safety of their
patients. In the following Frequently Asked
Questions (FAQs), our Board of Directors
provides patients who have breast implants with
information about the ongoing PIP/ROFIL breast
implant controversy.
1. What is wrong with the affected PIP/ROFIL
implants?
The French manufacturer Poly Implant Prostheses
(PIP) and the Dutch company Rofil Medical used
inferior, industrial grade, silicone in the
breast implants they produced and sold. These
products have a higher rupture rate than other
available implants. Rupture can cause
inflammation from silicone leaking out into
surrounding tissue.
2. Which implants are affected?
Affected products are PIP breast implants that
were used since 2001. These implants were also
marketed under the name M-implant by the company
Rofil Medical in the Netherlands and distributed
in Germany by the company Rofil Medro. Affected
Rofil implants are designated as IMGHC-TX,
MX-IMGHC, and IMGHC-LS. There is strong
suspicion that PIP and ROFIL implants that were
manufactured before 2001 are also affected and
are prone to a higher rupture rate and therefore
silicone leakage.
3. How do I know what brand of implants I
have?
Typically, patients receive an implant ID card
after such an operation which gives information
about the implant, the size and the batch
number. The surgeon's name and the date of
implantation should also be recorded. If you do
not have such a card, we recommend that you
contact the surgeon who performed the procedure
to check his records and tell you.
4.How high is the risk that the implant shell
can rupture and for silicone to leak out?
Recent studies by the French authorities
determined a risk or rupture of up to 11.1% for
PIP implants. In conventional implants, the
rupture rate is up to 2%. The durability of the
PIP/Rofil implants appears to be much lower than
normally accepted standards.
5. What happens when silicone leaks from an
implant?
Cracks in the outer shell of the implant can
allow silicone to leak out and enter the
body. First, the silicone passes through the
lymphatic system into the lymph nodes in the
armpit. From there it can move into the internal
organs, which is rare. This industrial grade
silicone can cause severe inflammation,
irritation, and in some cases effusion. On the
basis of previous studies, no increased risk of
cancer was shown.
6. Do I notice when an implant ruptures?
Probably not because a crack in the implant
shell can remain unnoticed, or it can lead to
non-specific changes. Enlarged lymph nodes in
the armpit should always be an alarm signal that
leads the patient to consult with their doctor.
After an accident or violent blow to the chest,
you should see your doctor so he can decide if
an ultrasound or magnetic resonance imaging (MRI)
examination is appropriate. These tests will
offer clues to determine if there is a rupture
or leakage, but often provide false negative
results - meaning that no silicone leaks are
seen.
7. What should I do if I have a PIP or Rofil
implant?
Definitely go promptly to the surgeon who
operated on you for a consultation. The
International Society of Aesthetic Plastic
Surgeons (ISAPS) strongly supports the
recommendation of the French authorities to
remove the implants as a precaution, even if no
symptoms or hints of rupture or leakage are
present. Of course, you can decide after
consulting with your doctor not to have surgery
and to return instead for regular checkups. If
you decide not to have the implants removed, we
recommend ultrasound or MRI scans twice each
year to check for ruptures.
8. Will my health insurance cover the
surgery costs to remove or replace the implants?
As
an international society with members in 93
countries we cannot provide an exact answer to
this question. We advise you to check with your
plastic surgeon and your health insurance
provider.
9.If I have my implants removed, is it
possible to put new implants in at the same
time?
If the implants are intact, it is always
possible during the same procedure to replace
them. If, however, there are complications
because of the state of the implant, it may be
that insertion of new implants in the same
operation is not possible if rupture has been
undetected for a longer period and if the
industrial silicone has caused an inflammatory
reaction in the surrounding tissue.
10. Do I need to look for a special surgeon?
As the implant removal may be complicated, you
should always look for a board certified plastic
surgeon as he will have the experience to deal
with unexpected problems. The forty-one year old
International Society of Aesthetic Plastic
Surgery is the largest international society of
individual board certified aesthetic plastic
surgeons with more than 2,100 members in 93
countries. Surgeons undergo a strict application
process to determine their qualifications to
join the society. You will find a list of ISAPS
members in your country on our website |
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