tag:theconversation.com,2011:/us/topics/breast-implants-2112/articlesBreast implants – The Conversation2023-09-25T15:03:20Ztag:theconversation.com,2011:article/2110902023-09-25T15:03:20Z2023-09-25T15:03:20ZImplants like pacemakers and insulin pumps often fail because of immune attacks − stopping them could make medical devices safer and longer-lasting<figure><img src="https://images.theconversation.com/files/549651/original/file-20230921-21-b8f110.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Foreign body responses can cause insulin pumps to degrade.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-diabetic-patient-keeps-an-insulin-pump-in-the-royalty-free-image/1041117870">Click_and_Photo/iStock via Getty Images</a></span></figcaption></figure><p>Biomedical implants – such as pacemakers, breast implants and orthopedic hardware like screws and plates to replace broken bones – have improved patient outcomes across a wide range of diseases. However, <a href="https://doi.org/10.1002%2Fbtm2.10300">many implants fail</a> because the body rejects them, and they need to be removed because they no longer function and can cause pain or discomfort.</p>
<p>An immune reaction called the <a href="https://doi.org/10.1002/adfm.202007226">foreign body response</a> – where the body encapsulates the implant in sometimes painful scar tissue – is a key driver of implant rejection. Developing treatments that target the mechanisms driving foreign body responses could improve the design and safety of biomedical implants.</p>
<p>I am a <a href="https://scholar.google.com/citations?user=TG52tUAAAAAJ&hl=en">biomedical engineer</a> who studies why the body forms scar tissue around medical devices. Along with my colleagues <a href="https://scholar.google.com/citations?user=XMWljcMAAAAJ&hl=en">Dharshan Sivaraj</a>, <a href="https://scholar.google.com/citations?user=UcM7zG8AAAAJ&hl=en">Jagan Padmanabhan</a> and <a href="https://scholar.google.com/citations?user=zY_J9IQAAAAJ&hl=en">Geoffrey Gurtner</a>, we wanted to learn more about what causes foreign body responses. In our research, recently published in the journal Nature Biomedical Engineering, we <a href="https://www.nature.com/articles/s41551-023-01091-5">identified a gene</a> that appears to drive this reaction because of the increased stress implants put on the tissues surrounding them.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/4h9nfYbov38?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Many implants need to be replaced because the immune system damages them over time.</span></figcaption>
</figure>
<h2>Mechanics of implant rejection</h2>
<p>Researchers hypothesize that foreign body responses are triggered by the chemical and material composition of the implant. Just as a person can tell the difference between touching something soft like a pillow versus something hard like a table, cells can tell when there are changes to the softness or stiffness of the tissues surrounding them as a result of an implant.</p>
<p>The <a href="https://doi.org/10.1096/fj.202101354">increased mechanical stress</a> on those cells sends a signal to the immune system that there is a foreign body present. Immune cells activated by mechanical pressure respond by building a capsule made of scar tissue around the implant in an attempt to shield it off. The more severe the immune reaction, the thicker the capsule. This protects the body from getting an infection from injuries like a splinter in your finger.</p>
<p>All biomedical implants cause some level of foreign body response and are surrounded by at least a small capsule. Some people have very strong reactions that result in a large, thick capsule that constricts around the implant, impeding its function and causing pain. <a href="https://doi.org/10.1002%2Fbtm2.10300">Between 10% to 30% of implants</a> need to be removed because of this scar tissue. For example, a neurostimulator could trigger the formation of a dense capsule of scar tissue that <a href="https://doi.org/10.1073/pnas.2115857119">inhibits electrical stimulation</a> from properly reaching the nervous system.</p>
<p>To understand why the immune systems of some people build thick capsules around implants while others do not, we gathered capsule samples from 20 patients whose breast implants were removed – 10 who had severe reactions, and 10 who had mild reactions. By genetically analyzing the samples, we found that a <a href="https://www.nature.com/articles/s41551-023-01091-5">gene called RAC2</a> was highly expressed in samples taken from patients with severe reactions but not in those with mild reactions. This gene is found <a href="https://doi.org/10.1128/mcb.22.21.7645-7657.2002">only in immune cells</a>, and it codes for a <a href="https://doi.org/10.1074/jbc.M306491200">member of a family of proteins</a> involved in cell growth and structure.</p>
<p>Because this protein seemed to be linked to a lot of the downstream reactions that lead to foreign body responses, we decided to explore how RAC2 affects the formation of capsules. We found that immune cells activate RAC2 along with other proteins <a href="https://www.nature.com/articles/s41551-023-01091-5">in response to mechanical stress</a> from implants. These proteins summon additional immune cells to the area that <a href="https://doi.org/10.3390%2Fma8095269">combine into a massive clump</a> to attack a large invader. These combined cells spit out fibrous proteins like collagen that form scar tissue.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Clinician holding a silicone breast implant" src="https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/549655/original/file-20230921-25-uccyoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The mechanical stress that medical devices like breast implants place on surrounding tissues can trigger a foreign body response.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/plastic-surgeon-holding-breast-silicone-implant-royalty-free-image/1300316377">megaflopp/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<p>To confirm RAC2’s role in foreign body responses, we artificially stimulated the mechanical signaling proteins surrounding silicone implants surgically placed in mice. This stimulation produced a severe and humanlike foreign body response in the mice. In contrast, blocking RAC2 resulted in an <a href="https://www.nature.com/articles/s41551-023-01091-5">up to threefold reduction</a> in foreign body responses.</p>
<p>These findings suggest that activating mechanical stress pathways triggers immune cells with RAC2 to generate severe foreign body responses. Blocking RAC2 in immune cells may significantly reduce this reaction.</p>
<h2>Developing new treatments</h2>
<p>Implant failure is conventionally treated by using <a href="https://doi.org/10.1186/s13036-019-0209-9">biocompatible materials</a> that the body can better tolerate, such as certain polymers. These don’t completely remove the risk of foreign body reactions, however.</p>
<p>My colleagues and I believe that treatments that target the pathways associated with RAC2 could potentially mitigate or prevent free body responses. Heading off this reaction would help improve the effectiveness and safety of medical implants.</p>
<p>Because <a href="https://doi.org/10.1128/mcb.22.21.7645-7657.2002">only immune cells express RAC2</a>, a drug designed to block only that gene would theoretically target only immune cells without affecting other cells in the body. Such a drug could also be administered via injection or even coated onto an implant to minimize side effects.</p>
<p>A complete understanding of the molecular mechanisms driving foreign body responses would be the final frontier in developing truly bio-integrative medical devices that could integrate with the body with no problems for the recipient’s entire life span.</p><img src="https://counter.theconversation.com/content/211090/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kellen Chen does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>From breast implants to prosthetic knees, implants can trigger a foreign body response that results in your body rejecting them. Suppressing an immune cell gene could reduce this risk.Kellen Chen, Assistant Professor of Surgery, University of ArizonaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1202812019-07-12T04:53:14Z2019-07-12T04:53:14ZThe TGA’s proposed breast implant ban exposes a litany of failures, and fails to protect women<figure><img src="https://images.theconversation.com/files/283810/original/file-20190712-173325-1pt3hyh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/192268697?src=kjE4cPpyMgy06bxX4_CuVg-1-7&studio=1&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">proposed ban</a> on some textured breast implants <a href="https://www.theguardian.com/australia-news/2019/jul/11/australian-ban-on-textured-breast-implants-recommended-over-apparent-cancer-link">announced</a> by the Australian pharmaceuticals and medical devices regulator earlier this week tells us something very disquieting about the effectiveness of consumer protection. </p>
<p>It will not reassure women living with breast implants concerned about their risk of cancer, or anyone else with an implantable medical device regulated by the Therapeutic Goods Administration (TGA).</p>
<p>It also exposes inadequacies in the regulatory system that have been apparent for years.</p>
<h2>What’s new?</h2>
<p>The proposed ban relates to the import and distribution of certain types of breast implants with a textured surface because of their <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">well documented link</a> with a rare type of cancer known as anaplastic large cell lymphoma. The proposal is unsurprising given bans in Europe.</p>
<p>But Australia’s proposal comes after months of <a href="https://www.abc.net.au/news/2019-04-09/implants-allowed-in-australia-after-crackdown-in-france/10985400">criticism</a> by consumers, medical specialists and legal <a href="https://blogs.crikey.com.au/croakey/2014/03/25/the-tga-a-watchdog-with-dentures/">academics</a> who wanted to see an earlier and better-communicated ban. </p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA also says</a> it is seeking advice from Allergan, the manufacturer whose implants were the focus of restrictions in Europe.</p>
<p>Yet concerns about the <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">safety</a> of a succession of implants and the <a href="https://theconversation.com/pip-breast-implant-controversy-shows-weve-learned-nothing-4896">inadequacy</a> of Australia’s regulatory responses are not new. Advice from Allergan should have been sought a year ago.</p>
<h2>Here’s what we asked the TGA last year</h2>
<p>In responding last year to our queries about implants, the TGA indicated that although importation of the textured implants had been stopped after the ban in France there were <em>no</em> restrictions on implanting those devices in Australia.</p>
<p>The TGA was unaware of how many implants were available for implantation. (Unawareness about what is on the shelf was also <a href="https://www.abc.net.au/news/2017-08-15/potentially-damaging-vaginal-mesh-kits-still-on-hospital-shelves/8805520">evident</a> regarding <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report">pelvic mesh</a>, a similar regulatory failure). </p>
<p>The TGA was not going to inform potential recipients of the implants, something that is at odds with its new-found <a href="https://www.abc.net.au/news/2019-04-04/medical-implants-overhaul-planned-after-icij-investigation/10964256">recognition</a> that patients are concerned about potential harms.</p>
<p>What we have now is a proposed rather than actual ban. It is driven by criticism rather than TGA initiative and does not provide much reassurance about the TGA’s capacity to prevent harms rather than slowly respond to harms.</p>
<h2>What if you are living with these implants?</h2>
<p>The proposal announced this week is restricted to import and distribution. It does not require removing all breast implants or all textured breast implants. It does however mean that people with the implants listed on the TGA website should be watchful.</p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA lists</a> the affected breast implants on its website, and says the risk of anaplastic large cell lymphoma associated with these is between 1-in-1,000 and 1-in-10,000.</p>
<p>Yet it’s likely many women will experience fear, alongside anger or bewilderment that the TGA has taken so long to act. </p>
<p>Some people will deal with that fear through preemptive surgery: removal of the implants after getting specialist advice. Costs will come out of their own pockets. Some will talk to lawyers.</p>
<h2>What’s the legal issue?</h2>
<p>Uniquely, consumers cannot sue the TGA if it gets things wrong. The TGA has a special <a href="http://www.austlii.edu.au/cgi-bin/viewdoc/au/legis/cth/consol_act/tga1989191/s61a.html">exemption</a> in its Act regarding civil litigation.</p>
<p>However, people who are injured by implanted medical devices can take manufacturers and medical specialists to court. Their challenge is to prove that the devices caused cancer or other injury. </p>
<p>Litigation in Australia with defective <a href="https://www.afr.com/business/health/hip-replacements-metalonmetal-implant-failures-trigger-new-class-action-fears-20181122-h187ha">joint implants</a> demonstrates that manufacturers have deep pockets and will be adversarial when it comes to <a href="https://www.abc.net.au/news/2016-03-31/class-action-over-defective-hip-replacements-settles-for-$250m/7288350">class actions</a> (litigation by groups of injured people) or individual victims. Litigation will often take years. Injury compensation will sometimes be inadequate.</p>
<p>That is one reason why better regulation is fundamental. We need to prevent the injury through timely action by government agencies rather than trying to fix a <a href="https://theconversation.com/failing-medical-implants-are-causing-hundreds-of-thousands-of-people-misery-84230">foreseeable</a> serious harm via legal action once it has occurred (and hope victims have the strength to fight for their rights).</p>
<h2>How engaged is the regulator?</h2>
<p>The <a href="https://www.tga.gov.au/who-we-are-what-we-do">TGA</a> is funded by the businesses it <a href="https://www.theguardian.com/australia-news/2017/nov/08/therapeutic-goods-administration-rejects-claims-it-is-too-close-to-medical-industry">regulates</a>. Like its counterpart the FDA in the United States, it is <a href="https://www.youtube.com/watch?v=UVUHEtrbL7A">underfunded</a> and demoralised. It views its mission through the eyes of those businesses, an example of <a href="https://theconversation.com/vital-signs-when-watchdogs-become-pets-or-the-problem-of-regulatory-capture-111170">regulatory capture</a>. It has been the subject of numerous <a href="https://theconversation.com/tga-all-bark-no-bite-as-labor-botches-response-to-a-series-of-reviews-4640">inquiries</a> about its performance. </p>
<p>Regrettably, the TGA has been described as unresponsive. It is comfortable dealing with the businesses it is supposed to regulate. It is <a href="https://theconversation.com/regulator-silent-on-safety-of-indian-made-generic-drugs-24013">uncomfortable</a> dealing with the public. It faces ongoing criticism about its apparent <a href="https://theconversation.com/medical-watchdog-turns-its-back-on-implant-safety-complaints-5744">indifference</a>. In response to such <a href="https://www.abc.net.au/news/2018-11-26/implant-files-shine-light-on-medical-device-industry/10521480">criticism</a> it belatedly announced an <a href="https://www.icij.org/investigations/implant-files/australia-announces-medical-device-action-plan-to-address-patient-concerns/">action plan</a> regarding oversight of devices. There hasn’t been much action. </p>
<p>In practice, meaningful regulation of devices is being left to <a href="https://www.icij.org/investigations/implant-files/">investigative</a> <a href="https://www.abc.net.au/news/2018-11-26/implant-files-reveal-tga-failures-in-medical-device-trial/10547486">journalists</a>, academics with a specialisation in law and medicine, and consumer advocates. Neither the Coalition nor the ALP have wanted to grasp the TGA <a href="https://theconversation.com/consumers-lose-out-as-tga-reform-turns-into-a-hot-potato-13383">hot potato</a>, but reform is necessary. </p>
<h2>What is needed?</h2>
<p>Our forthcoming research demonstrates the cost of running the TGA is dwarfed by the cost to patients, national productivity and the taxpayer of the TGA’s failures. </p>
<p>TGA legislation needs to be amended, in particular to ensure that the protection of consumers comes ahead of relations between the regulator and business. Independence of manufacturers is imperative. Adequate resourcing is essential. So is a cultural change within the TGA, including meaningful engagement with consumers rather than closed-door consultations with business.</p>
<p>Underpinning those changes we need a comprehensive <a href="https://www.abc.net.au/news/2018-03-27/pelvic-mesh-implants-tracking-medical-devices/9588070">database</a> of implants and incidents, one readily accessible by epidemiologists. </p>
<p>We need trust in the health system and in gatekeepers such as the TGA. Anyone with an implant or considering an implant needs to know that the TGA will actively minimise harms rather than relying on assurances from businesses that have a vested interest in minimising disclosure. Good regulation involves more than a quiet life for regulators.</p><img src="https://counter.theconversation.com/content/120281/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraWendy Bonython, Associate Professor of Law, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1006462018-08-10T10:37:42Z2018-08-10T10:37:42ZFrom breast implants to ice cube trays: How silicone took over our kitchens<figure><img src="https://images.theconversation.com/files/230925/original/file-20180807-138709-tpz6cw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">One plastic is particularly well-suited for the kitchen's extreme temperatures.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/rainbow-silicone-confectionery-utensils-536261188?src=ooExSphR9L6zzGZBDpKT1Q-1-90">Oksana Shufrych</a></span></figcaption></figure><p><em><a href="https://theconversation.com/el-largo-viaje-de-la-silicona-de-los-implantes-mamarios-a-la-cocina-101414">Leer en español</a></em>.</p>
<p>One of my ice cube trays is a small, yellow novelty tray that, when placed in the freezer, molds water into <a href="https://www.amazon.com/TrueZoo-Quack-Silicone-Tray-Candy/dp/B016MDCVGO/ref=asc_df_B016MDCVGO/?tag=hyprod-20&linkCode=df0&hvadid=198093537739&hvpos=1o2&hvnetw=g&hvrand=1388193119741366153&hvpone=&hvptwo=&hvqmt=&hvdev=c&hvdvcmdl=&hvlocint=&hvlocphy=9001989&hvtargid=pla-320469877138&psc=1">little duck-shaped pieces of ice</a>. </p>
<p>You’ve probably seen ice cube trays like this in all types of shapes, from <a href="https://www.amazon.com/Tovolo-Airplane-Flexible-Silicone-Dishwasher/dp/B01BOWEL2U/ref=asc_df_B01BOWEL2U/?tag=hyprod-20&linkCode=df0&hvadid=193124474144&hvpos=2o20&hvnetw=g&hvrand=16830887659611946038&hvpone=&hvptwo=&hvqmt=&hvdev=c&hvdvcmdl=&hvlocint=&hvlocphy=9001989&hvtargid=pla-309634405098&psc=1">airplanes</a> to <a href="https://www.ebay.com/p/Superman-Logo-Silicone-Ice-Cube-Tray-DC-Comics/28014409522?iid=361049382193&_trkparms=aid%3D222007%26algo%3DSIM.MBE%26ao%3D2%26asc%3D52935%26meid%3Dd60e403b30ef4db88c04522aabdc3bcd%26pid%3D100623%26rk%3D2%26rkt%3D6%26sd%3D121521678886%26itm%3D361049382193&_trksid=p2047675.c100623.m-1">superhero logos</a>. </p>
<p>While these trays have become commonplace, they symbolize how the material used to make them – silicone – has transformed our kitchens over the past two decades.</p>
<p>Silicone was originally invented <a href="http://imageserv5.team-logic.com/mediaLibrary/99/BE1110_CWIEME_Paper_2011.pdf">as an insulating material</a> for high temperature electric motors and would later be commonly used for breast implants. But designers eventually realized that it was an ideal material for a range of household goods.</p>
<h2>Mars rovers and … muffin molds?</h2>
<p><a href="https://artdesign.uoregon.edu/product-design/kiersten-muenchinger">Design engineers like me</a> love working with silicone because of its durability, flexibility and affordability. </p>
<p>Silicone, also known as polysiloxane, is a polymer – the word scientists use for plastics – that’s known for its rubbery feel.</p>
<p>It also has features that other materials simply don’t have. For example, <a href="https://mars.nasa.gov/mer/technology/is_severe_environments.html">Mars rovers</a> have silicone parts and coatings because the material is able to withstand extremely high and low temperatures, all while holding its given shape. </p>
<p>Think back to the rubbery silicone ice cube tray. It retains its shape in freezing temperatures but is still flexible enough that it can be twisted to pop out the cubes, without cracking. Then it returns back to its original shape.</p>
<p>There are other <a href="https://en.wikipedia.org/wiki/Thermoplastic_elastomer">flexible polymers</a> that can do this, but they tend to be a bit sticky to the touch – which isn’t the best quality for objects that come into contact with food. </p>
<p>Also, silicones – like most plastics – have low heat conductivity, which means they don’t transfer temperature well. This makes them ideal for <a href="https://www.amazon.com/Silicone-Microwave-Dishwasher-Chef-Buddy/dp/B076QN4J84/ref=asc_df_B076QN4J84/?tag=hyprod-20&linkCode=df0&hvadid=216776299397&hvpos=1o12&hvnetw=g&hvrand=8338350111167197303&hvpone=&hvptwo=&hvqmt=&hvdev=c&hvdvcmdl=&hvlocint=&hvlocphy=9060086&hvtargid=pla-383197241939&psc=1">muffin forms</a>, <a href="https://www.walmart.com/ip/Trudeau-Maison-Silicone-Loaf-Pan-Gray-Mint-8-5-X4-5/440592580?wmlspartner=wlpa&selectedSellerId=1453&adid=22222222227136290811&wl0=&wl1=g&wl2=c&wl3=245197858504&wl4=pla-402090640454&wl5=9060086&wl6=&wl7=&wl8=&wl9=pla&wl10=112550049&wl11=online&wl12=440592580&wl13=&veh=sem">loaf pans</a> and <a href="https://www.ebay.com/p/10inch-Spiral-Silicone-Bundt-Swirl-Ring-Cake-Baking-Tin-Mold-Mould-Pan-Bakeware/21008206177?iid=282272044289&chn=ps">Bundt cake pans</a>. You won’t burn your fingers as you’re popping out your baked treats.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/230921/original/file-20180807-191025-13ec73m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">If you use silicone bakeware, you won’t burn your fingers as you would with a metal pan.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/orange-pumpkin-pie-silicone-bakeware-1148562773?src=aPbtfif1J1NRPGZCzdF9og-1-29">TYNZA</a></span>
</figcaption>
</figure>
<h2>Silicone gets a bad rap</h2>
<p>How did this space-age material with incredible properties become a standard material for kitchen products? </p>
<p>It all started with breast implants.</p>
<p><a href="https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064461.htm">Beginning in the 1970s</a>, silicone was the primary implantable material used for breast implants and other body augmentations. Breast implants used two types of silicone. There was a firm silicone used for the shell and a viscous silicone gel used as the filler.</p>
<p><a href="https://www.webmd.com/beauty/breast-implant-safety#1">Safety concerns</a> about silicone breast implants cropped up in the 1980s. Some patients who had received implants complained of fibromyalgia, arthritis and other symptoms. The symptoms seemed to go away when the implants were removed, and people suspected that <a href="https://www.nytimes.com/1991/09/24/us/bristol-myers-is-quitting-breast-implant-business.html">silicone gel was leaking from the outer shell</a>. This suspicion couldn’t be proven, but the public started to become wary of silicone implants, while the plastic came to viewed as a dangerous material. There wasn’t much of a market for products that used it. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=496&fit=crop&dpr=1 754w, https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=496&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/230926/original/file-20180807-191019-1kumlpp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=496&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A silicone gel breast implant is shown at a manufacturing facility in Irving, Texas.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Breast-Implants-FDA-Review/01cb8589489d4f4ea850ac99face7fc6/24/0">AP Photo/Donna McWilliam</a></span>
</figcaption>
</figure>
<p>Yet by this point, chemists and engineers had developed entire catalogs of silicone materials that could withstand a huge range of temperatures, had amazing elasticity and flexibility, and possessed very low thermal conductivity. Importantly, because many were used for breast implants, they had already undergone rigorous safety approvals and certifications. They had also received FDA food-contact certification in the United States.</p>
<p>All that was missing was a vision for how they could be more widely applied, and a public appetite for silicone products.</p>
<h2>Perfect for messy kitchen work</h2>
<p>In the mid-1990s, I worked in an international design firm that helped companies and startups design new products. One day, two polymer sales technicians came to my workplace with a three-ring binder containing strips of silicone samples.</p>
<p>The strips had been dyed in a wide range of vibrant colors. Some had been molded with different textures, from <a href="http://www.zippybuy.com/images/iImages/Cases/Apple/iPhone_4/app_ip4_sc_pink_bumpy_back.jpg.pagespeed.ce.GTqVUx0wY9.jpg">little bumps</a> to stylish <a href="http://www.wi-engraving.com/popular-textures">chevron</a> patterns. The samples varied by <a href="https://web.archive.org/web/20070707141201/http://www.calce.umd.edu/general/Facilities/Hardness_ad_.htm#3.5">durometer</a>, a measure of the level of squishiness. Some were translucent, while others were opaque, crystal clear or even filled with glitter.</p>
<p>They told us that they wanted to reboot silicone’s image – to feature it in an array of household products – and asked us for suggestions.</p>
<p>I don’t remember the specifics of what we told them that day. But I wasn’t surprised when, as the years passed, I started seeing more and more silicone being used for kitchen products. It may not have initially been marketed as a silicone product, due to the bad press the material had received. Yet it makes perfect sense for kitchens, which are like mini laboratories – the science and technology centers of a household. </p>
<p>When cooking, we apply extreme heat and extreme cold; transform matter from liquid to solid; and mix, melt, cut, mash and stick. </p>
<p>Silicone makes all of this messy kitchen work much easier.</p>
<p>When you stir biscuit dough, you can grip a silicone mixing bowl much more easily than its slippery porcelain counterpart. The super-sticky dough is easier to clean off a silicone <a href="https://www.amazon.com/dp/B00GWVRW3Y?aaxitk=eDhDHdoSgtNNSZUhjFUeIw">stirring spoonula</a> and a <a href="https://www.amazon.com/Silicone-Measurements-Conversion-Non-Stick-Non-Slip/dp/B01DIIWQV6/ref=asc_df_B01DIIWQV6/?tag=hyprod-20&linkCode=df0&hvadid=198068498826&hvpos=1o1&hvnetw=g&hvrand=9873169892980308412&hvpone=&hvptwo=&hvqmt=&hvdev=c&hvdvcmdl=&hvlocint=&hvlocphy=9060086&hvtargid=pla-318733750799&psc=1">silicone mat</a>, which you can use for rolling out and cutting the rounds. And the bottoms of my biscuits don’t brown as much when using a <a href="http://www.mmgood.com/silicone-baking-mat-vs-parchment-paper/">silicone baking mat</a>. </p>
<p>We know more about silicone now. It is still <a href="https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm259866.htm">used in breast implants</a> that are approved by the FDA if the manufacturer agrees to maintain long-term health studies. There is even a brand, <a href="https://www.webstaurantstore.com/sasa-demarle-silpat-ae295205-01-8-1-4-x-11-3-4-quarter-size-silicone-non-stick-baking-mat/89529520501.html?utm_source=Google&utm_medium=cpc&utm_campaign=GoogleShopping&gclid=EAIaIQobChMIoqDfoY_Z3AIVhchkCh3QEwHrEAQYASABEgISD_D_BwE">Silpat</a>, whose name is a riff on silicone.</p>
<p>I often think about how silicone continues to have a range of important applications, whether it’s in outer space, <a href="https://www.ecstuning.com/b-ecs-parts/kohlefaser-luft-technik-intake-system-with-silicone-inlet-tube/009199ecs01-01%7Ea/?gclid=EAIaIQobChMIpOvowZHZ3AIVCf5kCh00rwZaEAQYASABEgKyF_D_BwE">in motor components</a> or <a href="http://www.todaysmedicaldevelopments.com/article/liquid-silicone-medical-devices-benefits-11517/">in emergency rooms</a>. </p>
<p>So each time I take out my rubber ducky ice cube tray and pop out some cubes for my seltzer, it’s a nice reminder of how an extraordinarily complex material can play a little role in day-to-day life.</p><img src="https://counter.theconversation.com/content/100646/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kiersten Muenchinger does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Kitchens are like mini laboratories, with foods and utensils exposed to extreme temperatures. So it’s no surprise that a material used for Mars missions has found its way into a range of cooking ware.Kiersten Muenchinger, Tim and Mary Boyle Chair in Material Studies and Product Design, University of OregonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/227962014-02-05T11:36:22Z2014-02-05T11:36:22ZCosmetic surgery boom not a sign of economic health<figure><img src="https://images.theconversation.com/files/40665/original/rng4z4wr-1391531018.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1024%2C683&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Fighting the laws of physics.</span> <span class="attribution"><span class="source">Dklimke</span></span></figcaption></figure><p>The number of cosmetic surgery operations in the UK hit <a href="http://www.theguardian.com/society/2014/feb/03/cosmetic-surgery-operations-top-50000">50,000 a year</a> for the first time in 2013. This is worrying given that <a href="https://www.gov.uk/government/news/recommendations-to-protect-people-who-choose-cosmetic-surgery">the Keogh review</a> into the industry following the PIP scandal, which saw thousands of women given <a href="http://www.bbc.co.uk/news/health-16391522">potentially dangerous</a> breast implants filled with industrial silicone, found it was woefully under-regulated.</p>
<p>The number of people undergoing operations will actually be much higher, as the British Association of Aesthetic Plastic Surgeons (BAAPS), which released the figure, only reports procedures carried out by its members. But it does suggest that the scandal may not have dampened demand for breast surgery. According to BAAPS it is the most popular cosmetic procedure with some 11,000 breast augmentations performed in 2013, <a href="http://www.theguardian.com/news/datablog/2014/feb/03/uk-plastic-surgery-2013-most-popular">followed by</a> eyelid and face lifts. </p>
<p>But claims that the increasing uptake of cosmetic surgery is a sign of a recovering economy express a dubious causality. Rajiv Grover, president of BAAPS said <a href="http://www.theguardian.com/lifeandstyle/2014/feb/03/would-you-have-plastic-surgery">the increase was</a> an “economic yardstick for recovery” because people spend more when they are confident in their money. But it might be that when jobs are scarce and competition fierce, looking good becomes all the more important, and cosmetic procedures become an investment in what you might call “body capital”.</p>
<h2>We need to get figures into shape</h2>
<p>BAAPS claims to represent a third of all cosmetic surgeons working in the UK, its representatives argue that the figures released show general trends in procedures from its members’ reported data – yet only certain procedures are registered. </p>
<p>Hair transplants and cosmetic dentistry, for example aren’t recorded, so the number of men having cosmetic procedures is underestimated. But from our own <a href="http://www.leeds.ac.uk/news/article/3409/first-hand_experiences_of_cosmetic_surgery_tourists_revealed">recent research</a> on cosmetic surgery tourism, a third of all patients travelling abroad for cosmetic procedures were men.</p>
<p>The fact that we don’t have full and accurate figures for the numbers undergoing surgery tells us that we’re still far from understanding – or regulating – this industry. </p>
<p>And as <a href="http://bit.ly/1fPxVTz">the Keogh review</a> said:</p>
<blockquote>
<p>To make matters worse, some doctors performing these operations are not based in the UK – they fly in to perform the procedure and then fly out.</p>
</blockquote>
<h2>Going under the knife</h2>
<p>In our study, which <a href="http://www.ssss.leeds.ac.uk/">explored motives</a> for surgery through 105 in-depth interviews with recipients in the UK, Australia and China, we found patient-consumers spent a lot of time researching their surgeries and choosing their doctors. But very little objective information exists on which to base these choices. Instead patients most often use word of mouth. </p>
<p>Clinic websites were not seen as particularly trustworthy, but social networking sites and cosmetic surgery forums provide opportunities for patient-consumers to talk to and get advice from previous patients of particular surgeons or clinics. They are a space where patients can record bad experiences as well as good ones.</p>
<p>A number of reasons also emerged for having cosmetic surgery, very few of which were related to “celebrities” or “perfect bodies” in the ways we often see insinuated in the media. The reasons that were most often cited in our study were:</p>
<ol>
<li><p>Correction: young women and men who wanted ear pinning, nose reshaping, breast surgery for symmetry, breast reduction for very large breasts or gynecomastia (benign growth of breast tissue in men), and breast enlargement when very little or no breast tissue was present.</p></li>
<li><p>Investment: it was young women who largely seek breast enlargements. Often the experience of having had cosmetic surgery was more important than the end result because it was seen to mark success or add “value” and “visibility” to bodies for those in competitive job markets. In South Korea, where cosmetic surgery is <a href="http://www.businessinsider.com/korea-is-obsessed-with-plastic-surgery-2013-5?op=1">very big business</a>, “small face” or jawbone “shaving” for women and blepharoplasty (eye-widening) as a graduation present for women and men are popular.</p></li>
<li><p>Repair: this was usually post-pregnancy breast uplifts and “tummy tucks” (these were also popular surgeries with women and men who had experienced dramatic weight loss), vaginal “rejuvenation” (often masking repair to birthing injury), and repair to other sudden body traumas – scar removal or sporting (or fighting) injuries to ears and noses.</p></li>
<li><p>Anti-ageing: fairly gender neutral, including face/neck/browlifts, blepharoplasty (an eyelid procedure) and hair transplants. These were often framed in terms of “remaining competitive”. Other people compared their bodies to homes with cracks in the walls and leaking roofs, which they wouldn’t let deteriorate in the name of “growing old gracefully”.</p></li>
</ol>
<h2>Class and credit</h2>
<p>Many people share the desire for better bodies for the reasons outlined above. But roles in the workplace and class also play a part. Those with little workplace experience, or people working in jobs where interaction with the public was very important – sales assistants, receptionists and beauticians, for instance – appearance and self-presentation may be key to getting a job in a highly competitive market. </p>
<p>But for middle-class professionals who are highly valued in their careers, what they look like is less important. Many prefer the idea of “<a href="http://fty.sagepub.com/content/7/2/179.abstract">natural beauty</a>” because <a href="http://books.google.co.uk/books/about/Formations_of_Class_Gender.html?id=BNS3FMBdRFIC&redir_esc=y">historically this was seen</a> as god-given and therefore emblematic of being morally good. </p>
<p>So “enhancements” can be deceptive, especially if you see beauty as an exploitative industry and a burden by which women – much more than men – are judged. It doesn’t mean they don’t have surgery but wealthy people can be very secretive about it, while those with less money may be more open about having surgery as a marker of social mobility but can often only afford it when credit is freely available. </p>
<p>And this brings us back to the idea of economic confidence once again – if numbers of cosmetic procedures are increasing then perhaps we should also think about the relaxation of credit restrictions, job competition, and not just consumer confidence. It was credit that got us into the economic crisis in the first place, let’s not forget. </p><img src="https://counter.theconversation.com/content/22796/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ruth Holliday receives has received research funding from the Economic and Social Research Council</span></em></p>The number of cosmetic surgery operations in the UK hit 50,000 a year for the first time in 2013. This is worrying given that the Keogh review into the industry following the PIP scandal, which saw thousands…Ruth Holliday, Professor of Gender and Culture, University of LeedsLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/130742013-03-28T03:28:48Z2013-03-28T03:28:48ZVictims of faulty breast implants were let down by the TGA<figure><img src="https://images.theconversation.com/files/21818/original/jb4nkyg6-1364428173.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The class action against the implant manufacturer has fallen over and despite the TGA's failings, victims can't sue the regulator.</span> <span class="attribution"><span class="source">Ilaria Gallo</span></span></figcaption></figure><p>The announcement this week by plaintiff law firm Tindall Gask Bentley that it was <a href="http://www.tgb.com.au/blog/tgb-withdraws-proposed-pip-implants-class-action">abandoning a class action</a> against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates critical defects in Australia’s regulatory framework for medical devices.</p>
<p>For five of the eight years that Medical Vision Australia Pty Ltd (MVA) was the sole Australian distributor of PIP implants, it apparently had no product liability insurance. The company is now in liquidation. There is no point in pursuing MVA, because there simply won’t be sufficient assets to compensate victims. The French manufacturer is facing criminal prosecution, and is also bankrupt.</p>
<p>These women - over 1,000 of whom had joined the action - have extensive claims for medical care and other costs. Removal of implants is not covered by the public health system, and some women <a href="http://www.abc.net.au/pm/content/2013/s3723408.htm">do not have</a> private health insurance.</p>
<p>Regardless of your views on implants, these women were consumers of a regulated product that they reasonably believed was safe. Like consumers of other medical devices including pacemakers, replacement joints, and stents, they put their trust in the <a href="http://www.tga.gov.au">Therapeutic Goods Administration</a> (TGA), the regulator responsible for ensuring that medical devices meet quality, safety and efficacy standards. They relied on the TGA to do the job it was entrusted with by legislation - to authorise release of medical devices to the Australian market, and, if necessary, revoke that authorisation. The TGA has let them down.</p>
<p>This is <a href="http://www.nytimes.com/1995/05/16/business/dow-corning-in-bankruptcy-over-lawsuits.html?pagewanted=all&src=pm">not the first time</a> breast implants have suffered large-scale product failure: the extensive litigation arising from leaking silicone breast implants in the 1990s should have warned the TGA that potential existed for failure of the PIP implants. </p>
<p>Similarly, this is not the first time the TGA has failed to respond appropriately to reports of problems with medical implants. Its response to concerns about <a href="https://theconversation.com/tga-slow-to-react-on-dud-hip-replacements-3802">DePuy hip and knee joints</a> has been <a href="http://parlinfo.aph.gov.au/parlInfo/download/chamber/journals/20111122_SJ069/toc_pdf/jnlf_069.pdf;fileType=application%2Fpdf#search=%22medical+devices+report%22">criticised by the Senate</a>, along with its management of the PIP implant failure. </p>
<p>The very fact that the products in question - foreign objects implanted into the human body - required regulatory approval should have provided a clue that the consequences of failure of these devices were significant. After all, if those implants were risk-free, regulation wouldn’t have been required in the first place.</p>
<p>Further compounding this regulatory failure, it appears that the TGA did not perform a basic due diligence check as part of its authorisation to market PIP implants by MVA. It appears that the legislation <a href="http://www.abc.net.au/pm/content/2013/s3723408.htm">does not permit</a> them to require marketers to hold product liability insurance. In an era of class action liability, this is simply incomprehensible.</p>
<p>The victims of PIP have been left without a remedy. To add insult to injury, they cannot even sue the TGA for negligence, because the TGA has <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s61a.html">legislative immunity</a> from the consequences of its regulatory incapacity or indifference.</p>
<p>The TGA is the gatekeeper standing between consumers and suppliers of medical devices. It is responsible for establishing the safety of these goods and to protect consumers from serious harm, the sources of which consumers themselves have no means of identifying. </p>
<p>When it works, that protection directly benefits the Australian economy through minimisation of hospital costs and lost productivity resulting from harm caused by unsafe medical devices and pharmaceuticals. When it doesn’t work, the costs are enormous.</p>
<p>In order to be effective, the TGA must be more assertive in revoking authorisations to market and distribute goods. It is not there to be an industry advocate, and it has to address perceptions of bureaucratic capture by industry. </p>
<p>It should have ensured that PIP’s distributor had sufficient product liability insurance at all times, and if it cannot under law, then this should be a top priority for legislative amendment. </p>
<p>The TGA is funded from the public purse. It is time it decides if it wants to be a real regulator. In the meantime, it would be a very good idea if the Commonwealth got its regulatory house in order, and provided the TGA with legislation that enables it to regulate effectively.</p><img src="https://counter.theconversation.com/content/13074/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates…Wendy Bonython, Assistant Professor, School of Law- Torts, Health and Biotechnology, University of CanberraBruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/48962012-01-10T19:23:26Z2012-01-10T19:23:26ZPIP breast implant controversy shows we’ve learned nothing<figure><img src="https://images.theconversation.com/files/6864/original/8j2q55h4-1326175842.jpg?ixlib=rb-1.1.0&rect=37%2C29%2C940%2C651&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Despite previous breast implant scandals, Australia still fails to gather data on cosmetic procedures.</span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p>The worldwide controversy around the safety of PIP (Poly Implant Prosthèse) breast implants has elicited different responses from governments, despite all of them seemingly acting on the same set of evidence. These responses illustrate how little we have learnt from the debate and worldwide litigation that raged around breast implants in the 1980s and 1990s. </p>
<p>From what has been reported to date, the evidence on adverse outcomes from these implants is weak. So, while the governments of the United Kingdom, France, Germany and the Czech Republic have advised women with PIP implants to have them removed, the Australian government has said there’s <a href="http://www.tga.gov.au/newsroom/media-2012-pip-120104.htm">no evidence to support their removal</a>. </p>
<p>The problem with the PIP implants arise from the fact that some of them were filled with industrial-grade silicone rather than more expensive, higher quality medical silicone. </p>
<p>Silicones are man-made compounds of silicon, carbon, hydrogen and oxygen. They’re used in cosmetics, to lubricate machinery, in foods and as hydraulic and brake fluid. If breast implants rupture, the silicone can leach into the body and the effects of this leaching is what is in dispute. </p>
<p>In many ways this new controversy is a replay of the Dow Corning scandal of the 1980s and 1990s, so problems linked to silicone breast implants are clearly not new.</p>
<h2>Re-living history</h2>
<p>Throughout the 1980s and 1990s, a number of class actions were brought against Dow Corning, an American manufacturer of silicone breast implants, in several countries, including Australia. Around 400,000 women worldwide were involved in the class action suits. </p>
<p>Claims linked the implants to breast cancer, autoimmune diseases and neurological problems. Such problems led to protracted legal proceedings in a number of countries, significant public controversy and debate, and the filing for bankruptcy by Dow Corning (the company was re-launched in 2004). </p>
<p>During the debate on the safety of silicone implants, stakeholders took expected positions. While lawyers and doctors acting on behalf of women claiming to have suffered damage from breast implants argued that they were toxic and unsafe, others argued there were no independent scientific data to verify such claims. In particular, those who manufactured the implants, and the doctors who implanted them, claimed that three decades of use proved that silicone implants were safe. </p>
<p>At the same time, the <a href="http://www.fda.gov/default.htm">US Food and Drug Administration (FDA)</a>, while acknowledging that anecdotal evidence was mounting against silicone implants, found insufficient scientific data to prove any toxic or other adverse effects. </p>
<p>In 1999, the US Institute of Medicine’s Committee on the Safety of Silicone Breast Implants <a href="http://www.iom.edu/Reports/1999/Safety-of-Silicone-Breast-Implants.aspx">reported</a> that they had found no evidence for silicone breast implants being associated with any disease. But the Safety of Silicone Implants report did note a high incidence of more localised complications, including implant rupture, infection and silicone leaking through the nipple or skin.</p>
<p>Significantly, it expressed concern that women who had silicone breast implants had not been informed about potential risks associated to the implants, and that risk of local complications had been understated.</p>
<p>And here we are, three decades later, facing the same issues about breast augmentation but with a different company producing the implants. Again the company is facing bankruptcy, and again, the response to the issue is confused. </p>
<p>We’re still unsure about the risks of silicone implants, we have failed to gather any robust or systematic evidence about their safety – even though the <a href="http://www.tga.gov.au/">Therapeutic Goods Administration (TGA)</a> says that in the last 10 years, around 5000 Australian women have received PIP implants. Because we don’t gather data in Australia about who gets what cosmetic procedure, we have little idea of who these women are, who carried out the procedures and whether any of the implants have ruptured. And we have absolutely no idea how many Australian women may have gone abroad, to countries such as Thailand, for their breast implants. </p>
<h2>Unlearnt lessons</h2>
<p>Clearly, the lesson from the PIP controversy (and the Dow Corning one before it) about the safety of breast implants is that we need better information.</p>
<p>Not only have we failed to systematically gather evidence about the safety of breast augmentation, in Australia, we don’t even know who has implants. If we are to avoid repeating the same mistake in another 20 years we need to gather better evidence, including data on any adverse impacts. We need longitudinal studies of how different breast implants perform, and to do this, we need to know who is getting the implants and who their surgeons are.</p>
<p>Second, women need to be better informed about <em>all</em> potential risks of breast implants, however, small. </p>
<p>It seems we learnt nothing from the Dow Corning scandal but now we have a second chance, one that will also help us start coming to grips with the rapid expansion of the cosmetic surgery implant industry. Otherwise we may be condemning another generation of women to exposing themselves to the unknown risks of breast augmentation. </p><img src="https://counter.theconversation.com/content/4896/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rhian Parker does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The worldwide controversy around the safety of PIP (Poly Implant Prosthèse) breast implants has elicited different responses from governments, despite all of them seemingly acting on the same set of evidence…Rhian Parker, Associate Professor and Senior Research Fellow, Centre for Research and Action in Public Health, University of CanberraLicensed as Creative Commons – attribution, no derivatives.