A list of some of the chemicals found inside an implant. Saline or silicone, they’re all the same. #Busted
A feature length documentary film which explores the potential risks and side effects associated with having breast implants.
A list of some of the chemicals found inside an implant. Saline or silicone, they’re all the same. #Busted
A list of some of the chemicals found in your “average” implant. Saline or Silicone...doesn’t matter. The chemical composition is the same. #Busted
This is Dr. Jan Willem Tervaert, director of Rheumatology at University of Alberta. In this shot, taken from the #Busted Documentary, he is reporting his findings from a study, known as “The Israeli Study” to the FDA. Here is some information to help the public understand what happens in the body of a person with breast implants:
1. The current evidence suggests some individuals may be predisposed to develop an immune-inflammatory reaction when exposed to select materials.
2. Patients develop local complications (AKA capsule formation).
3. Patients develop symptoms such as flulike disease, fatigue, myalgias (AKA “breast implant illness“ “human adjunct disease”, “ASIA”).
4. The immune system is not able to recover from the chronic stimulation: immune deficiency resulting in frequent infections.
5. The immune system makes “mistakes”: auto immune diseases, allergy and monoclonal proliferation ( AKA non-Hodgkin’s lymphoma such as ALCL). Thank you for your testimony and your interview Dr. Tervaert, and for continuing to treat women around the globe. #Busted.
This is a quote from @Busteddoc. Dr. Blais has been studying the effects of medical devices since the early 80s. He fell into a niche with breast implants during the mid-90s after his testimony was used as key evidence in the Dow Corning case. In the film he explains how and why breast implants can reek havoc on a woman’s system. Dr. Blais still operates his business and dissects breast implants to this day!!Thank you, Dr. Blais. #Busted
Meet: Karen McDougal
Occupation: Model, Playmate of the Year 1998
Implanted: March, 1996. Smooth saline on top of the muscle
Symptoms: Chronic fatigue, thyroid issues, allergies to everything, eyes were consistently red/sick looking, blurred vision and dizziness most of the time – blacking out or almost passing out many times a day, hard to breathe, having trouble swallowing or a choking feeling, memory issues, heart palpitations, light sensitivity, which made it hard to even look outside — and when she did, she felt dizzier. Karen went to the doctor, neurologist, hormone doctors – but they all said “There’s nothing wrong, you are healthy, maybe you are depressed.”
Explanted: January 31st, 2017
Results post-explant: “Whenever I was sick, I felt like I was slowly dying. All I could do was lay in bed, cry and pray to God, asking him to please don’t take me yet..give me one more day! I got sicker and sicker for years before I finally realized that there was one solution: getting my implants removed.” Almost all her symptoms have improved. Her vision isn’t blurred, severe knee pain is gone, migraines gone, dizziness gone. Karen remains about 90 - 95% better and is dedicated to advocacy on this topic, helping others who think they might be suffering from Breast Implant Related Illnesses. #busted
A quote from @busteddoc. Dr. Diana Zuckerman has been helping women who are sick from their implants for almost 30 years. She is currently helping women find out if their insurance might cover an explant. To learn more go to: center4research.org
Meet: Dr. Lu-Jean Feng. She is internationally recognized for her explant surgeries. In part because she’s been performing them longer than almost anyone in the field. For the last 36 years, Dr. Feng’s been telling women things like: “You’re not crazy” and “I believe you.” While making this film, we interviewed women from the 90s and women from today who had explanted with Dr. Feng and described her refreshing calm demeanor and insightful intelligence. Dr. Feng was one of the first surgeons to use autogenous tissue in breast reconstruction in the 80’s and 90s, during the height of the silicone breast implant controversy. She was also one of the first surgeons who recognized breast implants were causing women to experience symptoms. A micro-vascular surgeon, she quickly carved a niche for herself in performing explant surgeries, an idea that wasn’t so popular with her male counterparts. So...sent herself packing and opened shop in Cleveland, OH to start her own practice. #TheFengClinic
Like some of the other surgeons in the film, she does NOT offer breast implants as an option to her patients. Dr. Feng also understands the lack of research being done on breast implants and their connection to illness. She is finalizing her privately funded research at the end of this year. This information will help the medical community better understand the science behind these devices and their relationship to certain illnesses such as auto-immune disease and ALCL.
One thing she mentions in the film is: “The first thing the women notice is their breathing. These devices sit so close to the heart and the lungs making it very difficult to breathe. Often times, they come off anesthesia and take a huge breath. They can finally breathe.”
Thank you Dr. Feng for believing in and listening to these women for all these years. You believed them at a time when it was VERY unpopular to do so and you’ve now become a hero in this space. Keep up the good work and we look forward to hearing more about your research. #BUSTED
This is Dr. Rankin performing an explant surgery. Dr. Rankin is one of a handful of surgeons in the world who no longer offer breast implant surgery as an option at their facility. We interviewed Dr. Rankin about the rise in explant patients and why some women get sick, while others don’t. He like many others in this field, don’t have enough scientific data to definitively pinpoint the “Why”. And for that reason, Dr. Rankin continued to offer implants to his patients, until his practice became so flooded with explant requests, that he had to build an additional facility to accommodate all the surgeries.
Dr. Rankin knew he needed science to better understand WHY the implants were making women sick and he used his own funds to conduct private research with any patients who were willing to be part of his study.
He said: “Something is there for sure, I think we are at the tip of the iceberg as far as figuring this one out.”
All of this begs the question, are breast implants safe? In the end, Dr. Rankin decided to focus his practice on implant removal until we learn more on why these devices are making women sick. Thank you Dr. Rankin. #BUSTED
Meet: Madris Tomes
Madris is a healthcare IT expert and strategist. She has spent her career focusing on medical device data and policy expertise for medical device companies, the federal government, healthcare providers and payers.
As a former FDA employee, she started seeing a huge discrepancy between the number of cases of women coming forward complaining of issues related to their breast implants (as well as other medical devices) and the actual numbers being reported to the FDA.
She saw the need for doctors to have more accurate information and created Device Events. A web-based tool that searches medical device post-market surveillance data and recalls in a way that provides more accurate data.
We interviewed Madris back in March during the recent hearings at the FDA. It was there we learned that the numbers of adverse side-effects from breast implants were far greater than what was being reported.
Shortly after the hearings, FDA Commissioner Scott Gottlieb announced in a tweet that the FDA plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.
To give you a little context: Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart surgery patients.
Because of people like Madris, doctors, patients, and surgeons are finally getting more accurate information. The FDA has already published previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years.
Madris’ data showed hundreds of thousands more accounts of #breast implant harm or malfunctions than had previously been acknowledged.
Thank you Madris. #Busted
Advocates: (From L to R) @lykinsjulie @maria.gmitro #TerriDiaz and #RobynTowt sharing their stories on #BreastImplantIllness and #BII with the people of #SanDiego. Some were receptive, others were informed and a few even broke down crying. For the women of #BISA it was all about raising awareness. They would shout: “Remember how implants were making women sick in the 90s? Well they still are!” We filmed people stopping in their tracks and turning around to find out more. Truth is, they aren’t stopping here. They have big plans for outreach with only a few goals in mind: 1. To potentially save lives and 2. To provide women the proper information so that they have informed consent before purchasing new implants. Wishing you the best of luck this week, ladies! #Busted @busteddoc
Meet: Paiy Hansra
Occupation: RealEstate Investor
Implanted: 2011, Saline Smooth, Alergan
Symptoms: Sever headaches, frequent severe migraines, fibromyalgia, unexplained, brain fog, loss of memory, numbness of upper limbs, muscle spasms, rashes and hives on skin, muscle twitches, sharp pains in the arms neck and other body parts, Autoimmune Rheumatoid Arthritis, weak immune system, frequent UTI, swelling and sharp pain in neck, arm and legs sometimes to the point where she had to immobilize for weeks because she was unable to function or move.
Explanted: July, 2018
Results post-explant: Symptoms have mostly improved but she still suffers from a weak immune system, active Rheumatoid Arthritis, and the heavy metals that are in her system. Paiy also has 4 major gene mutations preventing her body from detoxing. These genes have mutated over the last few years. Her body tested positive for heavy metal toxicity, lead, cadmium & aluminum so many more mostly related to immune system. Paiy is in the process of detoxing. Her recovery has taken longer due to the gene mutations. She also suffers from occasional migraines and a weakened immune system. #Busted
Meet: Ashley Milus
Occupation: Certified Health Coach and Registered Nurse
Implanted: 1999 McGhan Saline implants
Symptoms: Extreme fatigue, Breathlessness, Flu like body aches and chills, Upper back and neck pain, Headaches, Facial pain/pressure, Back of skull pain
Eye aches, eye pressure, Brain fog, Difficulty concentrating, Light sensitivity, Sound sensitivity, Muscle aches, Joint pain, Cold intolerance, Raynaud syndrome, Foot pain on bottoms of feet, Tingling in extremities, Hand stiffness and pain, Sick often with colds, night sweats, Weight loss.
Explanted: May, 2018
Results: Very little improvement with her symptoms. Energy levels have improved, slightly. Ashley was diagnosed with Chronic Inflammatory Response Syndrome (CIRS/Mold Illness) in April of 2019 and is slowly making progress with her treatment.
Ashley is one of a small number of women who explant and their symptoms do not improve. However, it can take time. One doctor we interviewed said: “Some women recover overnight and others can take up to 4 + years.” It is also worth mentioning the strong link between BII victims and CIRS. Many of the women we interviewed with BII have been diagnosed with CIRS. The question is: Did they have CIRS all along or was it somehow triggered by their having breast implants?
Meet: Danielle Valoras
Occupation: Physician Assistant/ Field Clinical Engineer
Implanted: December, 2015
Allergan Natrelle, Smooth, Silicone Gel
Symptoms: Connective tissue issues, pain, swelling, breast and arm numbness, limited range of motion and strength, insomnia, fatigue and anxiety.
Explanted: October, 2017
Results: 80% better at explant, still living with residual effects of numbness, strength and autoimmune-like issues. Toxic levels of heavy metals like Arsenic and Mercury were found in Danielle’s blood & urine tests post-explant.
What peeked our interest whenever interviewing Danielle, was that she was in the medical device industry for over 20 years. Specifically, she supported clinical studies and taught doctors how products like pacemakers and ablation technology effect the body. Danielle talks about the strict protocols and best practices she and her team adhered to. Danielle assumed whenever she got her breast implants that the individuals testing those devices were held to the same standards. #Busted
Meet: Terri Diaz
Occupation: Business Owner of Sparkly Life by Terri VP/ Florida-BISA/Breast Implant Illness Florida Support
Implanted: February 2006. Under the muscle. Mentor High Profile Saline.
Symptoms: chronic fatigue, anxiety, impaired cognitive functions, ibs, colitis, food allergies, mast cell, vertigo, chronic candida, lyme disease, thyroid, extreme low vitamin d, extreme low b-12, mercury poisoning along with other high metals, completely bedridden.
Explanted: December 2016 enbloc/total capsulectomy.
Results Post-Explant: Most symptoms are gone. She feels 90% better. Terri still has gut issues but her energy has increased 100%.
Terri’s poster shows us some of the complications associated with BII: She was bedridden, diagnosed with multiple-autoimmune disorders, and experienced hair loss. What’s more telling is the vibrance in her skin and eyes only 10 days after her explant.
Raylene, Robin, Julie & Bill on the DC Metro headed to our nation’s capital to meet with their Senators and representatives to encourage, inform and educate them on the #MedicalDeviceSafetyAct.
The Medical Device Safety Act was introduced in House in 2017, by #RosaDeLauro, #LouiseSlaughter, since its introduction, other members of Congress have signed on. This bill amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by federal prohibition on state or local requirements regarding medical devices.
Rosa DeLauro said:
“The U.S. has a systemic problem with medical device oversight and unfortunately the Food and Drug Administration is not doing its job as a regulatory agency....Congress should step up and pass both the Medical Device Safety Act and Medical Device Guardians Act to give patients more resources needed to ensure their health and safety,”
On May 2nd, 2019 the FDA released the following response: "The FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness. We believe women considering a breast implant should be aware of these risks. We are taking steps to better characterize the condition and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms....At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act."
However, BII/ALCL victims continued their outreach and efforts to try and get textured implants, (which have a much higher incidense rate of BIA-ALCL) pulled from the market. Their efforts paid off and on July, 24th 2019 Allergan BIOCELL textured breast implants were pulled from the market. Please note: prior to July, 24th every other 1st world country had pulled these from the market, except for the United States. #ThankyouFDA #Babysteps #advocacy #outreach #BII #biaalcl
The purpose of this meeting was to discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.
#Busted #BII #textured #patients #data #silicone #saline #reconstruction #safety
Los Angeles, CA
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