PIP Implant Recall 2010 – Further UPDATE for Patients
Around 2010-2104 there was cause for concern and media reports regarding breast implants manufactured and distributed by PIP & ROFIL Medical Netherlands BV.
These implants were recalled in 2010 following concerns by the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of rupture and concerns that they contained unapproved ingredients.
These implants were available in Australia between 1998 and 2010.
There have been conflicting reports and recommendations with regard to the necessity of removing and replacing these implants. We understand that this is a decision that only you should make when clearly informed and we would like to ensure that we keep you up to date with the latest updates as they come to hand.
There is evidence of an increased rupture rate for PIP breast implants used in Australia compared with other brands – see TGA Article.
The Australian Government’s advice remains that removal of PIP breast implants in the absence of evidence of rupture is not routinely required. The TGA’s preliminary tests show no intra-dermal irritation in PIP implants.
On Sunday evening 11th March 2012, two TV shows aired regarding PIP implants – Sunday night (Channel 7) and 60 Minutes (Channel 9) both addressed the issues of the implants. Links to both the programs are available below.
The TGA made the following comment on their website on the 23rd March 2012.
“To date, the results of the tests conducted by TGA on both new and surgically removed (explanted) PIP breast implants have met all the international standards that apply to other breast implants and which the manufacturer of the breast implants should have conducted to seek proper approval of these devices in the first place.”
Further Reading – References about PIP Implants
The Australian Government has set up a free-call help line for individuals concerned about their breast implants. The telephone number is 1800 217 257 and can be called 24 hours per day.
There are several websites that can provide you with true and accurate information regarding these implants. Please see below:
Dr Doyle used some PIP Implants at Gold Coast Plastic Surgery – 2007 to 2010
At Gold Coast Plastic Surgery we used the PIP brand of breast implants from 2007 – 2010. Not all of our patients receiving a breast augmentation in this time frame have these types of implants. This was determined on an individual basis in consultation. We have attempted to contact the patients involved via post. Unfortunately, if your address details have not been updated, people may have been missed. Please feel free to contact our rooms if you had a breast augmentation with us in this time frame and are concerned about the type of implants that you have.
“As it has been more than 10 years since any PIP breast implants were used in Australia, they should probably be removed or replaced. If you are concerned about your implants please contact Gold Coast Plastic Surgery.” – Says Dr Doyle
Ultrasound and MRI are the most common investigations used to determine if the implants have ruptured. MRI is a more accurate investigation but until 11th March 2014 was much more costly. As a result of the problems surrounding these particular implants MRI’s are now available with a Medicare rebate.
Dr Doyle comments – “My recommendation is that all patients with PIP implants should have medical imaging to determine whether the implants are intact, or have ruptured. Please contact the office and we can organise an ultrasound or MRI for you.”
For more information about your concerns about PIP Breast Implants – please contact Gold Coast Plastic Surgery