Are breast implants safe?

Bangkok Bright Smile

Wed, 22 Feb 2012 2:41


Breast augmentation is currently the most requested plastic surgery procedure worldwide. However, a recent widely publicised health scare involving sub-standard breast implants manufactured by French company PIP, has generated concern about the overall safety of breast implants.

South African plastic surgeon, Stuart Geldenhuys, assesses whether silicone breast implants are safe or not.

In the wake of reports that followed an investigation by regulatory authorities in Europe, Poly Implant Prosthese or PIP implants have been found to contain an inferior industrial grade of silicone that does not meet the same stringent quality requirements as medical grade silicone, and their rupture rate appears to be five times higher than other implants.

Ruptures expose breast tissue to this toxic industrial grade silicone resulting in chronic inflammation.

"A panic situation such as the one that has been created by the inferior PIP implants can cause women who were considering breast augmentation to feel worried about the procedure," says Cape Town plastic surgeon, Stuart Geldenhuys.

"My advice to anyone wanting breast augmentation is to do your homework and find a reputable plastic surgeon that is a member of local or international bodies.  Also – find out what implants the surgeon uses and reassure yourself that they are safe."

Fortunately, in South Africa PIP implants are not frequently used, with other FDA approved brands proving more popular with local plastic surgeons.

But what about the other brands of implants on the market – are they safe?

According to Geldenhuys refinements in surgical and anesthetic techniques along with major advances in breast implant technology have, and will continue to, impact favourably on the safety and reliability of this popular procedure.

"The quality of silicone implants in general has significantly reduced the risk of rupture, rippling and capsular contracture.  The FDA has officially ruled that breast implants are safe, with identified complications such as leaking, rupture or scarring occurring rarely."

Geldenhuys, who is a member of the International Society of Aesthetic Plastic Surgery (ISAPS), offers the following advice from ISAPS to anyone worried about their implants:

In the interest of patient safety Dr Geldenhuys is in agreement with the ISAPS recommendations that all patients with PIP implants have them exchanged, unless or until such time as contrary evidence becomes available.

Should you be worried?

Firstly, it is important to find out what brand of implants you 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, contact the surgeon who performed the procedure to check his records and tell you.”

What should you do if you 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.

The Association of Plastic and Reconstructive Surgeons of South Africa (APRSSA) differs in their opinion and feel that in the absence of clinical symptoms of rupture, patients should not be advised to have their implants removed, but should have regular follow up examinations and yearly sonar appraisals.

How high is the risk of rupture?

Recent studies by the French authorities determined a risk or rupture of up to 11.1 percent for PIP implants. In conventional implants, the rupture rate is up to two percent.

However, according to the Plastic Surgery Association (APRSSA), statistical evidence on the rate of rupture compared to other implants is incomplete and cannot be assessed accurately.  Only 1.7 percent of women with PIP implants are known to have ruptured.

What happens when silicone leaks?

First, the silicone passes into the "intra-capsular" space immediately surrounding the implant where it may be contained.  If there is a breach of this capsule, an "extra-capsular" leak can occur and breast tissue will be exposed to silicone, resulting in inflammation of the surrounding breast tissue. This industrial grade silicone used in the PIP implants may cause severe inflammation. However, on the basis of previously published scientific studies in leading Plastic Surgery and Oncology Journals, no increased risk of cancer has been demonstrated. 

Do I notice when an implant ruptures?

Not necessarily because a crack in the implant shell with leak into the intra-capsular space may not result in any visible changes in breast shape. Furthermore, an implant with cohesive gel (filling) will tend to maintain its shape much like a "jelly mould".

Any alteration in breast shape or consistency or alteration in sensation should be investigated further. 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 may offer clues to determine if there is a rupture or leakage.

If implants are 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.