Today the Therapeutic Goods Administration (TGA) announced an ‘Action plan for Medical Devices’. The TGA claims that ‘the safety of Australian patients comes first’, however it has failed to update the Australian public about any of the international or national developments on breast implants.
So please share this update and help us inform the Australian public.
Breast implants are not lifetime devices, the longer a woman has breast implants the more likely she is to experience local complications or adverse outcomes.’
Dr Steven Nagel:FDA Advisory Committee Meeting on Breast Implants
Last week, the US Food and Drug Administration (FDA), held a two-day advisory committee meeting on breast implants that included a panel of experts who listened to researchers, plastic surgeons, implant manufacturers, as well as emotionally heart-wrenching personal testimony from patients. The meeting was convened by the FDA to determine the necessary information consumers require in making an informed decision on breast implant surgery.
The testimony included graphic images of blackened, hardened, explanted breast implants oozing silicone; harrowing stories from women with life altering physical and emotional complications (including implant ruptures, implant migration, capsular contracture, cancer and breast implant illness);mortifying evidence of women and their families being financially crippled trying to seek medical treatment for their complications; surgeons arrogantly dismissing breast implant illness symptoms as hysteria perpetuated by social media support groups and manufactures determined to convince the committee that the benefits of breast implants outweighed the risks.
At the end of the two days testimony, we were utterly devastated, enraged and astounded at the systemic incompetence of manufacturers, regulators and surgeons.
*Incompetence, by surgeons and manufacturers who had not warned patients that their breast implants were in fact not inert, required lifelong monitoring and posed serious health complications.
*Incompetence, by the FDA, for allowing manufacturers to hide at least 350,000 breast implant adverse event reports in summary reports.
*Incompetence, by manufacturers, who were arrogant and reprehensible in suspending breast implant trials and blatantly ignoring participants when they attempted to enquire about their trial’s status.
*Incompetence, by surgeons and mesh manufacturers, who thought it acceptable, to wrap breast implants in both biological and synthetic surgical mesh, knowing it was not cleared for this use by the FDA and that no data existed on its safety and efficacy.
Once again the hearing highlighted that a Royal Commission is desperately needed into how implantable medical devices like breast implants are regulated in Australia. Australian consumers and their families who have been irrevocably harmed by untested and unregulated medical devices deserve answers and justice.
In Australia, breast implants have been implanted into women and transgender women for decades. Despite their extensive use and several attempts to record breast implant surgeries with voluntary, not mandatory, Breast Device Registries, we still have no clear indication or database to determine the number of women or transgender women who have had a breast augmentation or reconstructive surgery in Australia. Furthermore, despite the existence of a Breast Device Registry and the TGA capturing date voluntarily for adverse event we also still have no accurate or public figures on the number of women or transgender women who have had their breast implants explanted due to complications. Unless surgeons, doctors and hospitals are regulated and mandated to report, and make public all explants and adverse events, then these figures will never be determined. It is however estimated that around 20,000 Australian women or transgender women will undergo breast augmentation or reconstructive surgery every year. This includes mastectomies to treat or prevent breast cancer and surgery for patient dissatisfaction, anatomical changes or genetic reasons.
Breast implants are either smooth or textured sacs that are filled with salt water (saline) or silicone gel. All breast implants, whether smooth or textured, are contained a silicone shell. This shell breaks down over time and causes silicone molecules to seep into the body. In addition to salt water or silicone gel, laboratory testing of both smooth and textured implants, identified chemicals including acetone, epoxy resin and lacquer thinner within breast implants. Currently, the regulatory agreements with manufacturers worldwide, allow regulators to withhold implant materials to patients and surgeons alike. This includes the listing of all ingredients and chemicals that are contained in both silicone and saline breast implants. These legal agreements consider implant materials, to be ‘proprietary information’. As Jamee Cook from Breast Implant Victim Advocacy highlighted to the FDA committee ‘surgeons can not guarantee informed consent for implantable medical devices like breast implants, if they are unable to disclose the ingredients contained in the products they are implanting’. It is ludicrous that cosmetic and food companies in Australia are required to publicly list all their product ingredients in descending order of weight to consumers, but manufacturers of implantable medical devices that contain toxic chemicals, including carcinogens proven to cause cancer are legally permitted to withhold this crucial information from the Australian consumer and public. (2,3)
Throughout the FDA hearing women repeatedly testified that they had not been warned of risks associated with breast implants. They spoke of suffering various symptoms such as muscle pain, fatigue, weakness and cognitive difficulties. Ailments now known collectively amongst women and transgender women with breast implants as breast implant illness.
Recently, research data and media reports worldwide have overwhelminglylinked a specific type of lymphoma cancer - BIA-ALCL - directly to textured breast implants. In Australia textured implants are used in about 90% of breast augmentations. Historically there have been three different levels of textured implants that manufacturers have produced. These include the Macro (highly textured), Micro (medium textured) and Nano (velvety textured). All three textured breast implants have been approved for use, distributed and implanted in Australia. On December the 17th, 2018, European regulators suspended Allergan Macro textured implants. In January 2019, the TGA convened an expert reference group that concludedmore evidence was required on textured implants before regulatory changes could be introduced. The group did however suspend Allergan implants in line with European regulators but agreed to let surgeons in Australia continue to implant their existing shelf supplies of Allergan textured implants as long as they were manufactured prior to the date of European suspension (December 17th 2018). It is unfathomable to us how the TGA could make this asinine decision. If an implant is suspended and known to cause cancer then the date it is manufactured will not change the serious health risks it poses. The TGA’s decision to allow surgeons to continue to implant Allergan implants only highlights its inability to prioritise and protect Australian consumers. (4,5)
On the 11th January 2019 the TGA confirmed quietly on its website that it had received 76 cases of lymphoma BIA-ALCL in Australian patients. While on March the 19th the FDA reported that it had identified 457 cases and nine deaths of BIA-ALCL in the United States and over six hundred cases and 17 deaths worldwide. The mounting evidence of BIA-ALCL cancer being detected in macro textured implants has now lead to France announcing today, April 2nd that it will prohibit the distribution and use of all macro-textured breast implants effective April 5.
We believe that our current Health Minister Greg Hunt, our Health Departments and regulatory bodies, should have followed Canada’s lead in issuing press releases on BIA-ALCL including symptoms to be aware of (pain, sudden swelling or a mass) and establishing a helpline service.
The data on BIA-ALCL and the rate it is being diagnosed in women, especially in Australia, means that this cancer, once considered rare, is now set to become an epidemic. It appears that both the Australian government and its regulatory bodies, are hoping that by turning their backs, and remaining silent on BIA-ALCL, they can keep this currently silent epidemicsilent. (6,7,8,9,10)
Already the FDA’s hearings on breast implants have led to greater transparency between regulators, manufacturers and the public. On Tuesday the 26th of March the FDA Commissioner Scott Gottlieb did a backflip on his statement concerning ‘summary reports.’ He had previously stated that the FDA had no immediate plans to release device-safety summary reports. However in an updated statement he added that the FDA were “looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible.”(11)
We will continue to keep you posted on National and International developments concerning breast implants and other medical devices.
However if you or someone you know is concerned about their breast implants and would like further information you can access the Australian Breast Implant Illness (awareness and support group) in the link below.
https://www.facebook.com/Breast.Implant.Illness.Awareness.Aus.NZ/
Once again we wish to thank everyone for signing and sharing this petition.
Respect and Gratitude
Please continue to share and spread the word.
References
3: https://www.betterhealth.vic.gov.au/health/healthyliving/food-labels
4: http://fda.yorkcast.com/webcast/Play/8f0ba1b148174747b4dbd0ec916167f11d
5: https://www.tga.gov.au/alert/tga-statement-allergan-breast-implant-withdrawal-europe
6: https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
8: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633890.htm
9: https://muhc.ca/newsroom/news/message-patients-having-had-breast-implant-surgery-muhc
11: https://www.nbcnews.com/health/health-news/device-safety-experts-fda-make-data-public-n987931