Breast implants
Risk of breast implants
Saline and silicone breast implants have similar risks. They include:
- breast pain
- changes in breast sensation
- internal scarring
- implant leakage or rupture
- the need for further breast surgery.
What happens if a breast implant ruptures
If a saline breast implant shell ruptures, the implant deflates. The leaking saline solution is absorbed without posing any health risks, but the silicone shell can only be removed with surgery.
If a silicone breast implant (this includes a PIP implant) ruptures, there may be no obvious change.
There is no evidence that leaking silicone gel causes serious, long-term health problems.
In some instances a ruptured silicone breast implant may eventually cause breast pain or changes in the shape of the breast. If this happens, you will need surgery to remove the ruptured implant.
Rupture rates of breast implants
The shells of breast implants have a relatively small failure rate. This includes PIP implants which have recently been the subject of a recall in some countries overseas.
PIP implants have a failure rate (rupture or leak) of around 0.4% for every year of implant, which is comparable to similar implants.
Health concerns with breast implants
There have been concerns that implants may increase the risks of some diseases including cancer and connective tissue diseases. However, the generally accepted view is that these are no more common in women with breast implants than in women without implants.
Follow up and ongoing medical care if you have breast implants
Follow-up care is generally provided by the surgeon and would usually involve an annual check-up.
Warning signs or symptoms that suggest breast implant rupture
Most women have no signs or symptoms following a rupture. However, some women may experience:
- pain, burning, tingling, swelling, numbness or redness in the affected breast
- hard knots or lumps surrounding the implant or in the armpit
- change in breast size or distorted breast shape
- softening or hardening of the breast.
If you have silicone breast implants and experience these signs or symptoms, consult your surgeon.
Concern around PIP implants
PIP implants are silicone-gel breast implants manufactured by the French company Poly Implant Prosthese (PIP). These implants were approved under the European regulatory system and were widely used in a number of countries.
In March 2010, French authorities learned that the company had used unapproved industrial-grade silicone filler instead of medical-grade silicone required under regulatory approval. A global recall of all PIP silicone breast implants was announced and clinicians were advised to no longer use these implants for breast implantation.
There were no records of their importation into or distribution in Aotearoa New Zealand. However, it has emerged a now-retired Wellington surgeon implanted PIP implants in 18 women in 2002 and 2003.
PIP implants have not been used for reconstructive surgery in the public health system. It is possible however that PIP implants may have been personally imported and used by other medical practitioners.
Health risks of PIP implants
Women with a PIP breast implant may be concerned about possible risks.
Breast implant testing by regulators in France, Australia and the UK, and subsequent review of data by expert committees, has so far found no evidence of harm or toxicity associated with the filler used inside the PIP implants. The data does not indicate the filler in a PIP implant can cause cancer.
On this basis, the health risks from a PIP implant is no different from that of any other breast implant.
Women with PIP implants also need to consider the risks of surgery to remove the implant as this may be greater than the risk posed by the PIP implants. Removal of a PIP or any other breast implant is only recommended where a patient’s doctor or surgeon believes it necessary due to rupture or other health concern.
Paying for treatment and advice
PIP implants were not used in public health procedures.
Our advice to health professionals is that, generally, patients who have privately funded medical treatment should continue with their private treatment for any follow up.
However, there may be situations where this is not appropriate or possible, and, depending on your discussions with your healthcare provider or surgeon, you may be referred to the public health system.
Treatment in the public system would be on the same basis as treatment of any other individual with a breast implant — on the basis of clinical need.
Contact ACC to find out if you can get ACC cover.
How are medical devices are registered in Aotearoa New Zealand
Since 2004 it has been a regulatory requirement for suppliers of medical devices (including breast implants) in Aotearoa New Zealand to notify details of their devices to a database known as the Web Assisted Notification of Devices (WAND) database maintained by Medsafe. To date there have been no notifications to the database for breast implants manufactured or filled by PIP.
Silicone Gel Breast Implants Manufactured by Poly Implant Prosthese (PIP) — Medsafe (external link)