In recent months the Therapeutic Goods Administration have undertaken an enormous amount of work, commissioning internal scientific reviews, meeting with external advisory groups, liaising with overseas regulatory authorities and research groups to advance public safety on sound scientific evidence for breast implant safety. We welcome news today that following the Therapeutic Goods Administration’s (TGA) thorough review of breast implants sold in Australia, they have taken a range of regulatory actions to address BIA-ALCL risks.
We are also pleased to advise that the high quality implants Dr Sharp uses (Mentor and Motiva) are not involved in any of the suspensions or voluntary recalls resulting from the TGA’s investigations, due to their low incidence of complications and BIA-ALCL rates.
All surgery carries risks, and patient safety is front of mind in every decision we make; as such, breast implant risks have been addressed by Dr Sharp in our clinics for years, with:
- the use of high quality micro and nano textured implants
- Dr Sharp taking the Macquarie University 14 Point Plan Pledge
- use of the Australian Breast Device Register for all breast implant procedures performed by Dr Sharp
- to promote patient awareness, the risk of BIA-ALCL is always included in the informed consent and consultation process with Dr Sharp. We believe that every patient deserves to be fully informed, and so this has been part of our practice, since long before it was recommended or required.
Even if you have macro textured breast implants, the TGA says removal is not required
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is very rare. Evidence based recommendations are that removal of breast implants is not required in a person who has no symptoms or concerns. If you have a breast implant and detect any change in the breast or armpit such as swelling, a lump or pain, you should consult your plastic surgeon.
Some breast implant devices have been suspended. This means that these implants will not be available on the Australian market for the next six months. During this period, the implant providers will have the opportunity to provide additional information to the TGA about their implants’ safety and performance.
The implants Dr Sharp uses are not included in the suspension
Suspended implants are those that are macrotextured - grade 3 and 4 and some microtextured implants associated with higher incidences of BIA-ALCL and other clinical concerns. To support the ongoing monitoring of BIA-ALCL, all cases of BIA-ALCL must be reported to the TGA by implant suppliers within 10 working days of becoming aware of the adverse event.
To support greater vigilance and increased awareness and data collection on this issue, the TGA requires implant suppliers to provide reports every six months. These reports must include supply data and detail all adverse events and complaints received regarding breast implant and tissue expander devices, both in Australia and worldwide, including BIA-ALCL, capsular contracture, or rupture of the implant.
In addition to this, Dr Sharp chooses to independently use the Australian Breast Device Register which records all implants he places. The Australian Breast Device Registry (ABDR) is a Commonwealth Government health initiative that records information on surgeries involving breast devices, such as breast implants. It is are a long term project to help safeguard the health of people undergoing breast device surgery. For many patients, the ABDR provides peace of mind that their device details are recorded. If you’ve had an augmentation, reconstruction or removal and replacement with Dr Sharp, your implant details are registered here for perpetuity.
What are micro and nano textured implants?
Textured implants were an innovation in implant science, developed to reduce the risk of a common complication, called capsular contracture. By texturing the implant’s surface, the body was less likely to create a thick, hardened capsule that constricted the implant and created a hardened, sometimes uncomfortable, result years after implantation. Also, because the implants weren’t textured, they didn’t tend to move around as much or rotate, so different shapes could then be used in a texture implant, like the tear drop or anatomical implants commonly used today - to create a beautifully sloped, natural looking breast many women desire. Prior to this, only smooth implants were used, and these always had to be round. This is because their smooth surface meant they could rotate, and an anatomical or tear drop implant that rotates will distort the breast shape.
We often warn that ‘all implants are not created equal’, because (among other factors), the type of texturing involved in the implant’s surface can determine how much bacteria it holds when being implanted. Some texturing holds a lot, while other texturing is cleverly engineered to offer ‘textured’ benefits with much lower risks of bacterial contamination and ensuing BIA-ALCL. These are the implants Dr Sharp uses.
When placed under a microscope, the difference between the surface topography and area of each implant brand can be seen, as they use very different techniques to create texturing. Learn more here about different breast implant surface textures, safety profiles and quality.
Breast implants and risks
To support informed patient choices, patients undergoing breast implants placement always have access to a patient information documentation that includes information about warnings and risks associated with implants. Information relating to the Australian Breast Device Registry is also included, to support ongoing reporting and monitoring. BIA-ALCL is very rare, and the clinical advice remains that, without symptoms, it is not necessary to remove your breast implants. Instead, patients who have breast implants, should regularly check their breasts and see their doctor if they notice any changes.
The Australian Society of Aesthetic Plastic Surgeons (ASAPS) response
As the preeminent body representing Specialist Plastic Surgeons who specialise in cosmetic surgery, the Australasian Society of Aesthetic Plastic Surgeons (ASAPS) has welcomed the TGA’s findings into breast implants and breast tissue expanders that were released today.
Dr Naveen Somia, President of the ASAPS, said the review has prioritised patient safety with the breast implants that have the highest risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), while leaving viable implant options for patients on the market.
ASAPS recommends that patients prioritise their safety when considering breast augmentation surgery by taking the following steps:
1. Seeking a surgeon who is accredited as a Specialist Surgeon by the Australian Health Practitioner Regulation Agency (AHPRA). These surgeons are committed to life long learning and best practice techniques and procedures
2. Ensuring their surgeon uses stringent breast implant infection control standards, such as the 14-Point-Plan
3. Having the procedure in a licensed facility
4. Confirming that their surgeon only uses TGA approved implants
If you have any questions or concerns regarding breast implant safety, call us on 3202 4744 to book a consultation with Dr Sharp and learn more about the steps you can take to ensure your optimal outcome and long term health when undergoing breast augmentation surgery.
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