The manufacturer of PIP breast implants was authorised to use a medical grade silicone but has used non-approved silicone in its production processes.
A specific serious safety concern for PIP breast implants has not been identified from the mechanical, toxicology or chemical tests carried out by the TGA to date. Specifically:
- Testing in Australia, the UK and France did not show any chemical toxicity to either living cells (cytotoxicity) or DNA within the genetic machinery of the cell (genotoxicity).
- Although the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) reported that intra-dermal irritation tests showed an irritant potential, intra-dermal irritation studies commissioned by the TGA in both Australian and French laboratories showed no evidence of irritation.
- The AFSSAPS reported that there are differences in the physical and chemical properties of different batches of PIP breast implants that relate to the use of authorised and unauthorised silicone filler gels. Testing by the TGA has also found such differences, particularly the presence of low molecular weight siloxanes, but these are not regarded as being of clinical significance.
- Although AFSSAPS reported failures related to the tensile elongation test, repeated tests conducted by the TGA (including tensile elongation) have met all relevant international standards for shell integrity.
Rupture can be asymptomatic, and the best imaging method of detecting rupture is MRI. Women who know they have a PIP breast implant, or where clinical advice is that they might have, can access a Medicare rebate for a MRI to assess the integrity of their implant/s. (available for MRIs performed from Monday, 12 March 2012, for a 12-month period).
There is no evidence that silicone gel filled breast implants cause breast cancer. There is a possible (but very low risk) link between all silicone breast implants and anaplastic large cell lymphoma occurring in the breast. There is no evidence of an increased risk for PIP breast implants compared with other silicone breast implants.
Some consumers with PIP breast implants have reported experiencing systemic symptoms such as fatigue, hair loss and headaches. While there is no published evidence that silicone gel filled breast implants cause connective tissue disease, the TGA is attempting to collect further information on these individual reports. As systemic or general symptoms can be experienced as part of many different health conditions, it is important that women experiencing these symptoms visit their medical practitioners to have these symptoms evaluated.
Local complications associated with explantation surgery (surgery to remove implants) are common. If replacement with new implants is undertaken, there is a likely increased risk of delayed complications such as contracture, rupture, implant removal and reoperation associated with the second and subsequent surgeries compared with the primary surgery.
Medicare rebates are available for the cost of medical services related to managing PIP breast implants concerns including GP and surgeon consultations, diagnostic tests and surgery and related anaesthetic services to remove and replace implants when clinically indicated.
Overall, there is not enough evidence to conclude that women with PIP silicone breast implants have a greater health risk than women with other brands. Australian tests to date have all been conducted in accordance with international standards and the results show the implants have met the standards required. Therefore, in light of the risks of surgery there is insufficient evidence to recommend routine removal of PIP implants without a medical indication such as rupture or significant symptoms.
Women are encouraged to discuss their individual situation with their doctor to assess the risks and benefits relevant to their own circumstances. Important information is provided in the Key Information box, section 1, to assist women and doctors in balancing these risks and benefits.
This report presents the information available to April 2012. Importantly, it comprises results from key tests conducted by the TGA and other regulators, and published scientific literature. Evidence continues to be accumulated by the TGA, and will be integrated into an ongoing risk assessment communicated via the TGA website and to consumer groups and clinician organisations, especially where this may be different from current advice.
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