France’s ANSM (their equivalent of Australia’s TGA) recently decided to prohibit the use of 13 macro-textured and polyurethane coated implants from six manufacturers. In Australia, the TGA has asked textured implant suppliers to provide detailed information and samples of their implants for analysis before considering whether to suspend or ban the products.
Our clinics do not use ‘macro’ textured implants; the two implant brands that we currently use are not included in France’s ban list; we chose our implant brands based on their very high quality standards.
The TGA announcement has caused understandable concern among women who have had breast augmentation surgery, with many wondering if their implants are safe, or require removal and replacement. The brand we predominantly use had its certification mark (CE) renewed by the European Union only two months ago, and carries the lowest rate of complications - such as BIA-ALCL and capsular contracture - partly due to the quality of its ‘micro’ coating.
Among other factors, breast implant related lymphoma (BIA-ALCL) has been linked to ‘macro’ textured breast implants. Due to their quality, the ‘micro’ textured implants we use are some of the more expensive on the market in Australia, but we believe the additional investment is worth the cost, offering unparalleled safety - and peace of mind.
What does this mean? Now more than ever, it’s important to:
- Know the brand and type of implants your surgeon uses
- Dr Sharp use Mentor and Motiva implants. Being able to identify the type of implant your surgeon uses is an important part of your pre-surgery education and informed consent. We believe patients deserve to know the brand of the implant a surgeon uses when they are researching the right surgeon for them.
- Before your surgery, ask your surgeon why s/he choses those implants
- We chose these implants because they are high quality prosthesis with sound science behind their design and warranty provisions; they are backed by reputable manufacturers. Secondary to this, they also provide a more natural feel and better result than other implants, in our opinion.
- Ensure you are aware of the implant’s warranty provisions and safety record
- With Medicare and private health insurers no longer covering implant replacement surgery, warranty provisions for rupture and capsular contracture are very important - not just because they save you money if you need to have the implants replaced, but it also signifies that the manufacturer takes responsibility for its product’s performance.
- Ask your surgeon if they have taken the 14 Point Plan Pledge
- Dr Sharp follows the 14 Point Plan. You can read more about why this improves the safety of our breast augmentation surgery here.
- Ask your surgeon if they register their implants with the Australian Breast Device Registry
- We do. After your surgery, you will receive your implant details. These are also saved to your electronic chart in our practice, and a copy is sent to the ABDR, so you have 3 ways of identifying your implants should you need to in the future. The data collected by the ABDR also unable us to track the long term performance of breast devices, and identify best surgical practices to ensure optimal patient health outcomes.
Are all textured breast implants the same?
No. The coating of the implants we use are calling ‘micro’ textured or ‘nano’ textured and differ significantly from those recalled; adhering to the highest implant quality standards. The safety of our implants is supported by clinical data, with our micro textured implants in particular being examined by three, 10-year prospective clinical trials. The risk of developing BIA-ALCL differs between different textured prosthesis and has been shown to be rare with the kind of breast implants we use; about one in 86,000 according to the most recent risk assessment published in the Plastic and Reconstructive Surgery Journal. Other implants carry a 1 in 2,800 risk, demonstrating that when it comes to safety, all implants are not created equal.
Read more about BIA-ALCL here.
Do I need to have my implants removed and replaced?
Currently there are no recommendations to have implants ‘preventatively’ removed. If your implants are causing you concerns - or if you are encountering a complication such as rupture or capsular contracture - see your GP as a first course of action. Seek the advice of your GP if you are experiencing:
- changes in shape or size
- pain or discomfort
- firmness / hardness
The GP will examine your breasts - and they might refer you for an ultrasound or MRI, along with a referral to a plastic surgeon. If you have a copy of your implant details, please bring them along to your consultation.
View before and after photos and read more about implant revision, which includes removal and replacement surgery, here.
BIA-ALCL: fast facts
• The incidence of BIA-ALCL remains rare.
• Most seromas are not BIA-ALCL
• As of September 30, 2018, the FDA had received a total of 660 medical device reports (MDRs) of BIA ALCL worldwide, including the death of nine patients. In Australia and New Zealand, 94 patients have been identified, a further two being worked up. This includes four women who have died. To put this number into context, in 2017 the International Society of Aesthetic Plastic Surgeons estimated that approximately 1,600,000 breast augmentations were performed that year alone.
• Diligent and systematic application of antimicrobial strategies at the time of breast implant surgery has been shown to be beneficial; that’s why Dr Sharp follows the Macquarie University 14 Point Plan.
• To date, although there are hypotheses, no one can claim to know the exact cause of BIA-ALCL. The hypotheses with most scientific support involve textured implants, the presence of bacteria, host genetic predisposition, chronic T-cell response with eventual monoclonal proliferation and transformation into lymphoma
• Updated Australian and New Zealand figures show that 70% of ANZ cases are diagnosed in stage 1 of the disease. In these cases, complete surgical removal is curative with enbloc capsulectomy and implant removal.
This article does not constitute individual medical advice; if you have any concerns, please see your GP for referral to a specialist plastic surgeon to receive advice specific to you and your implants.