Key Information: Silicone gel filled Breast Implants
Health consequencesAll silicone gel filled breast implants are considered high risk medical devices
- They have a limited lifespan - the risk of rupture increases with time, with an estimate of 10-15% by 10 years.
- A rupture may not present with any clinical signs or symptoms.
- Magnetic Resonance Imaging (MRI) is the best imaging method to detect rupture. No imaging test currently can predict rupture.
- Silicone from ruptured breast implants may migrate, resulting in swollen and sometimes sore lymph nodes.
- There is no evidence of increased risk of breast cancer or connective tissue diseases.
- There is a possible link between all silicone breast implants and a specific but rare cancer called Anaplastic Large Cell Lymphoma (ALCL), but any risk appears very small.
- Testing by the Therapeutic Goods Administration (TGA) has not identified a specific serious safety concern with PIP breast implants.
- It has been suggested that PIP breast implants may be more likely to rupture than other silicone gel-filled breast implants. The information we have cannot confirm or exclude this possibility but the number of reported ruptures in Australia to date is within an expected range.
- There is no evidence that the risk of ALCL in the breast for PIP breast implants is greater than for all silicone gel filled breast implants. No cases of ALCL in the breast in women with PIP breast implants have been reported in Australia.
Removing breast implants (explantation surgery)All silicone gel filled breast implants
- Surgery for ruptured breast implants is not urgent, unless there are signs of breast tissue reaction.
- As with all surgery, there are risks associated with anaesthesia. In healthy people, as expected in the majority of women with breast implants, the risk of death associated with anaesthesia is approximately 1/100,000.
- Local complications are common.
- If replacement with new implants is undertaken, there is a likely increased risk of delayed local complications such as contracture, rupture, implant removal and reoperation associated with the second and subsequent surgeries compared with the primary or initial surgery. If necessary, reoperation may be required earlier following revision surgery than primary augmentation 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.
- A Medicare rebate is available for MRI to assess the structural integrity of known or suspected PIP breast implants for a 12-month period, until 12 March 2013.