Why it’s so important to make sure your details are included in the ABDR (Australian Breast Device Registry).
Recommencement of some elective surgery this week is a timely reminder for anyone considering or preparing for breast implant surgery to make sure your surgeon includes you in the Australian Breast Device Registry.
This registry has the purpose of monitoring and tracking the long-term safety and performance of implants, tissue expanders and dermal mesh used in breast procedures.
The ABDR is funded by the Commonwealth and free for contributing Australian patients and surgeons. Medical records only need to be legally kept for seven years. The ABDR provides an accessible record of your breast device if you should need it in the future. It also enables faster communication about your device from your surgeon (if ever required).
Ask your surgeon to include your procedure details (insertion or removal of breast devices) in the ABDR. For more information about this world-leading, confidential registry: website abdr.org.au, Facebook: @AustralianBreastDeviceRegistry, Twitter @BreastDeviceReg
Here’s our podcast
Trish Hammond Hello listeners it’s Trish Hammond here again from the Plastic Surgery Hub transforming bodies podcast. And today we’re going to have something totally different for you. I’m actually speaking with two wonderful ladies. The first one is Dr. Ingrid Hopper, and she’s a physician and academic, and heads the Breast Device Registry. Also online will be specialist (delete s) plastic surgeon, Dr. Gillian Farrell, a member of the Australian Society of Plastic Surgeons and one of three clinical leads of the Australian Breast Device Registry.Today we’re going to be talking about the Breast Device Registry and why it’s so important and give you a whole lot of a rundown of it (DELETE TODAY) . So welcome, ladies.
Dr Ingrid Hopper & Dr Gillian Farrell Thanks. Thank you, Trish. It’s wonderful to be here. And thanks for the opportunity to help raise awareness.
Trish Hammond I only found out about it a couple of years ago and I thought my god, I can’t believe it wasn’t around sooner. So can you just tell us a little bit about it like why was it first of all? Why was it started and when was it started?
Dr Ingrid Hopper & Dr Gillian Farrell The ABDR was started in response to the PIP incident back in 2010. As you will be aware, there was a French company that had been producing implants that were not to an acceptable standard. Although they were required to use medical-grade silicone they were using industrial-grade silicone and produced implants that had a higher than expected rupture rate. So the TGA undertook a hazard alert to notify the Australian public about these implants. Some women tried to access the Breast Implant Registry that was running at the time, which was in what’s called an “opt-in” registry when patients paid some money to be included. Unfortunately, that particular type of implant hadn’t been well collected by the registry and they were only able to trace around 3% of the patients who had them. So there was a Senate committee, a senate review that was undertaken, that came to the conclusion at that time, they would like a registry for the entirety of Australia so that patients are automatically included, although they can choose to opt-out their data if they wish. This is at no cost to patients. If this type of situation were ever to occur again, then we would be able to identify and facilitate those patients being notified in a much more timely fashion. So the registry was designed and piloted back in 2011. Then in 2015, we were fortunate to get funding from the Commonwealth Government in order to undertake a national program. And we’ve been rolling out the program ever since then.
Trish Hammond Wow, you know what, like I speak to ladies all the time, and I can’t believe how many people don’t know, number one where they got their implants, who did them, what they got.! So this is going to solve all those problems for people, isn’t it? It’s just it just makes so much sense.
Dr Ingrid Hopper & Dr Gillian Farrell We all lead busy lives. And it is very difficult to keep track of these things. And one of the things about breast implants is that they’re put into, often, women who are very well, and they just get on with their lives, as expected. And they don’t think about keeping a record of their device.
One of the great advantages of the Breast Device Registry is that we are tracking and monitoring the safety of these devices in the background so people can get on with their life knowing that we have the data there, and it’s only a phone call away if they need it.
So let me just give a bit more clarity about what a “breast device” is. It is a medical device, something that is put into the body, to either enlarge or recreate a breast. These devices are regulated by the TGA. They include breast implants, as well as tissue expanders, and acellular dermal mesh and similar products. So all of those products fall under our registry.
Trish Hammond So the Breast Device Registry, is not just for patients is it really?
Dr Ingrid Hopper & Dr Gillian Farrell Ensuring patient safety by tracking and monitoring the long term safety of breast implants is the most important purpose of the registry.
But there are a number of other roles that the registry plays. It also supports continuous quality improvement in both surgeons and hospitals. We have over 500 surgeons who contribute data and are involved with the registry. And they can use the data that comes back from the registry to review their own performance and their own techniques, then use that data to help identify both the best breast devices and the best surgical techniques that will result in the best outcomes for patients. So the surgeons can really have a lot to gain from being involved with the registry. It also supports hospitals in order to help them give the best care possible for patients.
Trish Hammond And it is like is it a compulsory thing? Can we be assured that every surgeon in Australia, who is putting a breast device into a woman or man or whatever, is actually going to register it with the Australian Breast Device Registry? Or is this something as consumers, we need to make sure or that we need to ask the question of our surgeon,
Dr Gillian Farrell To answer that question, we would very much like it to be a mandatory expectation that surgeons comply with using the breast implant registry but at the moment, it’s not mandatory. However, we have a very high percentage of implanting surgeons that do comply and there’s a lot in this for the surgeons as well as for the patient. Surgeons are very keen to improve quality of care and patient safety is absolutely paramount in our work so we see the registry as being very positive and the fact that it’s an opt-out registry has helped a lot with the number of participants. However it’s still possible for a surgeon to choose not to comply with the registry, and it’s possible for a patient to opt-out. And it would be really good if any patient considering having implants would ask the question of her surgeon as to whether they’re going to be putting her on the registry or not. Because ultimately, it may be the only way that she can find out later what implant she has, and that actually could become really important in years to come.
Trish Hammond Yeah well I’m surprised it’s not compulsory, and I don’t know how it becomes something that’s mandatory, but I think it’s absolutely essential, that we to include Information about the ABDR on all of our lists or information that we send out to patients And, you know, put it out there to make sure you ask the question about whether there’ll be a record of this on the breast device registry, it just makes so much sense.
Dr Ingrid Hopper & Dr Gillian Farrell Yeah, I completely support that. I mean, there are other factors such as that medical records only legally have to be kept for a period of seven years. And that means that even if a patient contacts her surgeon, the original surgeon, which should be a very good way of finding out what implants she has, the records may not exist anymore, or the surgeon might have retired. So one of the ways the patient can benefit is to find out what implant they have. And secondly, we can track those devices and see if there’s any that are not performing as well as others.
Trish Hammond And I guess that kind of answers my next question perfectly is like why, you know, your surgeon should include you in on the registry. So, number one, if anything goes wrong, you know, you’ll be number one, you’ll be advised, like, because what about if someone moves?
Dr Ingrid Hopper & Dr Gillian Farrell If someone moves, it would be an ideal scenario that they would let us know and update their details. And that just goes on a list of jobs that they have to do when they move, to let the Breast Device Registry know they’re changing details. One of the things we do have when patients register, or when we receive their data, is that they do have the option to give us a number of different methods of contacting them. So there’s obviously postal and email address, mobile phones, and mobile phones seem to be the most consistent of all. People normally let us know their mobile phone number when they get onto the Registry. But in answer to your question about what are the main reasons to for a patient to go on the Registry, it’s really for that peace of mind, I think to know that in the background, the safety and the performance of the breast devices is being monitored. And women can get on with their lives and not have to worry about that. It also facilitates faster communications in the event that the TGA does make a decision that patients need to be contacted. And we can help surgeons contact their patients by giving them a list of patients who had that particular device. That can occur much faster than it was previously because this is actually the first time that we’ve had this resource in Australia to be able to use in this manner.
Trish Hammond And I guess, flipping it around the other way is that also say, for example, if I’ve got implants and something goes wrong with my implants, is that going like it, although it’s the breast device, you know, although it’s a registry, will that sort of information be logged in there as well? Like I go back to my doctor and one’s been ruptured and or, like, Is it going to be a is it just like a register or do you have other info that goes on there as well so that, you know data can be accumulated over years or not.
Dr Ingrid Hopper & Dr Gillian Farrell The data is added to because every time a patient with implants has surgery in relation to their implants, the surgeon has to fill out another form. For example, if an implant is ruptured and, the woman goes back to her surgeon and it requires to be replaced, that would all be documented. The data in relation to her implant and her new implant, the replacement implant would all be on the register. So it’s not just about a repository for the actual implant details, it’s about what happens in the future to that implant and to the patient. You know, it’s a very valuable data that will get better as time goes on.
Dr Ingrid Hopper & Dr Gillian Farrell Trisha, if I could just describe the process of the data to you. It might help.
Trish Hammond Yes, please. I was going to ask how it works?
Dr Ingrid Hopper & Dr Gillian Farrell So the way it works, was a woman goes to see her surgeon, the surgeon will give her a leaflet explaining that her data will be transferred across to the registry. At the time of surgery, the surgeon fills out a form and then notifies us that the surgery has occurred and then we receive the form. Once we receive the form, we then send a letter to the patient, letting her know that her data has been received by us, and how we’re going to use that data. And that she can opt-out from the Registry should she so desire and the way that she could to do that either with a telephone call or an email to us. We will later contact registrants to check in with them about how their implants look and feel. And that’s usually done by text message or telephone call. And then patients can just tell us what’s happening, how their implants are performing. Then when they go on to have a further operation, either for a complication or because of their own change size or any other reason, we then receive another form and contrary to what you might think, that is as important as the information going in about the implant, the information about the implant coming out. So then we get to understand how long the implants been in there if any complications occurred, what were they? And also what are the reasons for change, whether it’s a patient choice, fear of any other conditions, or discomfort, pain, complications related to capsular contracture, which as you would be well aware is the commonest complication or device malposition. All of these things we get from the information further on down the track. So, another word for the listeners, if you do go back to have an operation, make sure you mention the Registry to your surgeon.
Trish Hammond And you know what, that that makes so much sense because it gives us an opportunity and as a country to learn what the most common complications are. And, you know, and there might be things that we can learn how to improve those patient outcomes. Hey, Like that, that’s kind of what it’s all designed for, isn’t it?
Dr Ingrid Hopper & Dr Gillian Farrell This is called real-world data. And it’s quite different from data that you get from, say, a clinical trial. So clinical trials, they only run for a couple of years, usually on a very small number of patients. The registry is able to track a vast number of patients and we have over 44,000 patients already and over 80,000 breast devices. And it will really tell us what’s happening in the real world, not in the ideal conditions that you might see in a clinical trial. But the other really important thing about this data is that it will be used by the rest of the world as well. I think Australia is in a unique position in that we have pioneered this registry. The data set has been picked up by a number of different countries, including the Netherlands, Sweden, the US and the UK. And over time, we’ll be able to combine our data sets so that we will get a clear idea of device performance across the entire world, not just in Australia. So in Australia, we have this amazing opportunity to make this registry and data set incredibly informative. And this knowledge will come from analyzing a lot of high-quality information. So we need everyone to be involved, everyone to be aware of it, everybody asking to be in the registry, and that will give us the data that we need.
Trish Hammond Thats absolutely true. And I guess it’s probably a good time as well to mention the fact that people have breast implants not only for cosmetic enhancement but also for reconstruction for a developmental deformity or following a mastectomy. It’s about improved wellbeing for a lot of women.
Dr Ingrid Hopper & Dr Gillian Farrell Yeah, absolutely. In the registry, we have 70% or so implants that have been put in for what is normally described as cosmetic reasons and the other 30% for reconstructive purposes. The reconstructive ones are a mixture of breast cancer patients and others that have a sort of developmental deformity such as asymmetry. The cosmetic group have very valid reasons for having breast implants which they perceive will improve their quality of life and most studies show that it does. I don’t think it’s up to anyone to be judgmental about people who choose to have cosmetic surgery. And we treat all the patients the same. There’s no difference really in the sort of complications that we’re looking for in the two groups although the incidence will differ as the reconstructive cases are often more complex.
Trish Hammond And it’s good to have both lots of information as well. Like you know, this was done for this reason, and this was done for that reason. So I think that would be, you know, that would be identified as well. So, I was just gonna ask you like, actually, I spoke to a lady last week and just a young girl, she’s not even 30, she’s had 14 different operations for her breast implants. And it’s just like, Whoa, like, she doesn’t even remember the first ones. And this is just one person. Whereas if this was around, when she first started, like, you know, you’d be there’d be some information there that you think well, hang on, okay, this, there’s something here that we need to, you know, work out what’s going on. So it just enables that sort of conversation to happen.
Dr Ingrid Hopper & Dr Gillian Farrell Certainly, that would be a very unusual situation. There are women who have had multiple implants over a number of years and there are a number of reasons for this. All patients these days are told that their implants may not last forever. You know that this is a device that is manufactured and inserted into a patient but, but no one really knows how long it will remain intact. So each surgeon has their own advice for patients with implants, but it is important that the patients understand that it is a lifelong commitment and they do need some sort of follow up. As a surgeon, my particular recommendation is that all women with implants have an MRI performed after 10 years because that will demonstrate if the implant is intact or not. And clinical examination and ultrasound are really not very accurate to assess that. It’s not an emergency to have a ruptured implant, but it does mean that the woman should start thinking about having her implants replaced. So I tend to see my patients once a year if they choose to be followed up that way, but that’s not essential. If they’re concerned about their implants I would recommend that the first port of call should be the original surgeon who should have the details of the implants and should be able to deal with any issues but if that’s not possible, certainly contact the breast implant register to find out and then to ask for a referral from their GP to see a specialist surgeon who does a lot of breast implant surgery.
Trish Hammond Look it makes sense because you go for a mammogram once a year, you go for a pap smear, you know it, you know, after a certain amount of time, you know, it just makes so much sense that this is another, you know, this is just something that you have to commit to doing after you’ve had breast implants. And like I had spinal surgery and I have to go to see my surgeon every year, it’s just, you know, it’s just should be a given really, so this is obviously like the first step to making consumers aware that hey, you know, this is something that you have to look after yourself and you should go and get them checked regularly.
Dr Ingrid Hopper & Dr Gillian Farrell It’s also a way that the surgeon can communicate with the patient if there are any issues identified with their particular implant. Another way to identify that is the TGA website tends to update their information regularly for patients with breast implants. So that’s quite an easily accessible website for patients with implants to look at.
Trish Hammond Yep. That’s a really good start because It’s very unusual people go looking for information. But yeah, if you’ve got implants probably great place to just go and have a look at the information out there and on that where can patients go to get more information about the Australian Breast Device Registry?
Dr Ingrid Hopper & Dr Gillian Farrell We’ve got a website. Interestingly, it links to the TGA website and I would thoroughly endorse what Gillian has said about the TGA website being a great resource. So for more information, our website is abdr.org.au. And Trish, I’d really encourage your listeners if they are considering having breast device surgery or know someone who was thinking about it to choose a surgeon who does contribute to the Australian registry.
Trish Hammond Yeah that makes so much sense. And I’ve got to thank you ladies, thank you so much for taking the time today because we’ve got a group of thousands of women in one of our Facebook groups that I can’t wait to they listen to this podcast because I know that you know, a lot of them are about to have breast implants and, and a lot of them have had them so be great opportunities and stop thinking, hey, hang on. I need to start to look after my boobs.
Dr Ingrid Hopper & Dr Gillian Farrell Terrific. Well, thanks for the opportunity. Trish. It’s been wonderful talking to you.
Trish Hammond Thank you so much. Have a great day.