As you may be aware, there has recently been some cause for concern regarding breast implants manufactured and distributed by PIP & ROFIL Medical Netherlands BV.
These implants were available in Australia between 1998 and 2010. At Gold Coast Plastic Surgery we used these PIP brand of implants from 2007 – 2010. Not all of our patients that received a breast augmentation in this time frame have these types of implants. This was determined on an individual basis in consultation. We have tried to contact the patients involved via post. Unfortunately, if 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 worried about the type of implants that you have.
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.
In December 2010, there was also media speculation and reports of a correlation between a rare tumour – Anaplastic Large Cell Lymphoma (ALCL). It is important to note that the TGA (Therapeutic Goods Administration), which is governed by the Australian Government – Department of Health & Ageing, has received no reports of this in Australian patients who have received PIP implants.
There are several websites that can provide you with true and accurate information regarding PIP implants. Please see below:
Therapeutic Goods Administration – www.tga.gov.au
International Society of Aesthetic Plastic Surgery – www.isaps.org
Medicines and Healthcare Products Regulatory Agency in UK – www.mhra.gov.uk
The Australian Government has set up a free-call help line for individuals concerned about breast implants. The telephone number is 1800 217 257 and can be called 24 hours per day.
The TGA’s advice to individuals with PIP silicone gel implants continues to be that, based on current rates of reporting of implant rupture to the TGA, there is no evidence of an increased rupture rate for PIP breast implants used in Australia.
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.
The Australian Government’s advice as at 24th February 2012 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 shows aired regarding PIP implants – Sunday night (Channel 7) and 60 Minutes (Channel 9) both addressed the issues of PIP implants. Links to both the programs are available below.
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 was a much more costly. As a result of the problems surrounding PIP implants MRI’s are now available with a Medicare rebate.
Ruptures are reported as being intracapsular or extracapsular.
- intra capsular: the gel is confined within the fibrous capsule around the implant
- or extra capsular: the gel has extended into the breast or other localised tissues.
Extracapsular is more significant than intracapsular.
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 PIP breast implants should have conducted to seek proper approval of these devices in the first place.”
TGA website – http://www.tga.gov.au/safety/alerts-device-breast-implants-pip.htm
Sunday Night http://au.news.yahoo.com/sunday-night/features/article/-/13105279/exploding-pip-breast-implants/
60 Minutes http://sixtyminutes.ninemsn.com.au/blogs/8433373/allison-langdon-pip-breast-implants
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.