14 February 2012

Silicone breast implants - are they safe or not?

A recent health scare involving sub-standard breast implants has generated concern about the safety of breast implants. Plastic surgeon Dr Stuart Geldenhuys reviews the situation.


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 Poly Implant Prosthese (PIP), has generated concern about the overall safety of breast implants.

South African plastic surgeon, Dr Stuart Geldenhuys, reviews the situation and the issue of whether silicone breast implants are safe or not.

In the wake of reports that followed an investigation by regulatory authorities in Europe, 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.

The French government issued a statement indicating that all PIP implants should be removed based on their findings of a projected 11.2% implant rupture rate and the use of non medical grade silicone which would lead to severe inflammatory reactions in contact with breast tissue.

Conservative approach

The UK's position (with potentially 50 000 patients with PIP implants), which is shared by the Association of Plastic and Reconstructive Surgeons of Southern Africa (APRSSA), is that there is insufficient evidence at present to corroborate the French findings and consequently that patients should adopt a wait-and-see approach. This should however include imaging of the breast to determine if there is any evidence to suggest possible implant rupture. Any signs would mandate immediate implant removal. Repeat evaluation and imaging is currently recommended at six monthly intervals.

This more conservative approach, whilst entirely logical without corroborating scientific evidence, offers little in the way of comfort for those patients with PIP implants who may feel they have a ticking time bomb in their breasts. 

In France it is estimated that a total of 30 000 women currently have implants manufactured by PIP, while in the UK 50 000 women have been advised to have these implants removed or replaced. 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 Cape Town plastic surgeon, Dr Stuart Geldenhuys, refinements in surgical and anaesthetic 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.”

“It’s important to recognise that there are a number of different breast implant manufacturers around the world and most maintain rigorous clinical development processes coupled with extensive manufacturing and quality assurance testing to ensure the highest quality and safety of their breast implants,” says Geldenhuys.

“In my own practice I use breast implants manufactured by Mentor, Allergan and Eurosilicone – all of which comply to various international standards such as ISO and EU requirements and are FDA approved.”

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 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%. 

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

What happens when silicone leaks from an implant?

Rupture of in the outer shell of the implant can allow silicone to leak out and enter the body. 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.

Do you need a specialist surgeon?

As the implant removal may be complicated, you should always look for a board certified plastic surgeon, registered with their national Plastic Surgery Association (APRSSA) and membership of the 41-year-old International Society of Aesthetic Plastic Surgery (ISAPS, the largest international society of individual board certified aesthetic plastic surgeons with more than 2 100 members in 93 countries) as they will have the experience to deal with unexpected problems.

Surgeons undergo a strict application process to determine their qualifications to join the society.

“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. 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.”

Dr Geldenhuys reiterates that in using the correct products and procedures, breast augmentation is an extremely safe and satisfying surgery that provides women with pleasing aesthetic results that positively affect their self-esteem.

Catalyst Communications press release

- (Health24, February 2012)

Pic: iStock

Read more:

Your guide to breast surgery
All about breast reconstruction


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