After a lengthy legal battle and initial defeat for victims, a French appeal court has awarded compensation to more than 2,500 women suffering long term health issues from faulty PIP breast implants which contained cheap, industrial grade silicon.
What was the finding?
A French Appeal Court has awarded compensation to women who sustained injury from PIP breast implants. This compensation is to be paid by German safety body, TUV Rheinland who, it was found, had negligently awarded safety certificates for faulty breast implants. These safety certificates were relied upon by government safety regulators, including the Therapeutic Goods Administration in Australia.
What are PIP Breast Implants?
PIP breast implants are silicon (as opposed to saline) implants manufactured by French company, Poly Implant Prothese. PIP was liquidated in 2010 after it was found that the PIP implants were filled with cheap, industrial-grade silicone which was not cleared for human use.
Were these implants available in Australia?
These implants were available in Australia for approximately 10 years before they were recalled in 2010. It is believed that during this period approximately 5,000 women had PIP implants surgically implanted in Australia.
How safe are PIP breast implants?
The position of the Australian Therapeutic Goods Administration, which remains to be tested, is that the PIP implants are as safe as any other breast implant in terms of rupture and that there is no evidence that breast implants, including PIP, are associated with a higher risk of breast cancer.
This contrasts with findings by Britain’s National Health Service which suggest that the faulty PIP implants are up to six times more likely to rupture. The poor-quality silicon has also been found to have leached into the bodies of women whose implants have remained intact.
Your safety going forward
The TGA is not recommending the removal of PIP implants unless a safety issue arises as their view is that the risk of the implants is not greater than the risk of the removal surgery. If you are affected, however, you really need to find a specialist you trust and be guided by their specialist advice.
If your specialist advice is that you should act to remove the PIP breast implants you also need to consider the safety of alternative products to be used as some patients moved to replace the PIP implants only to find that their replacement implants, Cereform, were also recalled.
Despite its current stance the TGA advises that is continues to monitor the position in relation to patients with PIP implants including conducting testing on available samples of PIP implants (including explanted devices), consulting with Australian and international experts to monitor merging evidence and working closely with international regulators.
Whether the TGA is relying on accurate data, however, remains to be seen with criticism that the Australian Breast Device Registry, established in 2016, is failing consumers.
I have PIP implants. What should I do?
If you have PIP breast implants (or any breast implants for that matter) you should consult closely with your GP & your specialist to monitor your health for any known risks.
Breast implant risks include auto-immune disease, cancer, anxiety, aching joints, pain, chronic fatigue, headaches, unexplained respiratory difficulties, hair loss, frequent skin rashes, chronically dry mouth, poor memory and concentration, depression, anxiety and insomnia.
Whilst this article relates specifically to PIP breast implant devices, there are many other models of breast implants. You should seek legal advice if you have suffered injury as a result of any breast implant surgery as there are often avenues available to pursue a claim.
In some cases, the injury does not relate to the device itself but rather the professional medical skills/methods used to implant it.
How do I know if I’ve had a PIP breast device implanted?
You may have been given a card after your surgery identifying the brand of implant. However, if you are unaware of the brand used your surgeon will be able to identify this for you. Your GP may also be aware of this information.
Be aware that PIP isn’t the only brand that’s been recalled in Australia. You can find information about the status of your implant at the TGA website.
Can I seek compensation as a patient with a PIP breast implant?
In the case of Australia, the sole importer, Medical Vision Australia, has managed to avoid medical negligence or product liability by going into voluntary liquidation in dubious circumstances after establishing related companies. It has since been sold. With little other choice at this time, many Australians have pursued compensation by joining court action in Europe against TUV.
In this recent French decision, some of the women who were injured were refused compensation, a testament to the complexity of the litigation, however you should seek legal advice to determine whether you can support a claim.
For information on obtaining representation in Europe for a PIP claim we recommend contacting the PIP Implant World Victims Association.