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COMING SOON: A documentary about the risks associated with having breast implants.
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FDA finalizes Black Box Warning for Breast Implants!!! This is a great day for the advocates who’ve been fighting the cause.  Kudos to the FDA for making this happen.  According to #MedTechDrive, here’s the breakdown:  1. FDA on Monday finalized labeling guidance for breast implant manufacturers, including a boxed warning informing patients that the products have been associated with development of a type of cancer of the immune system.
2. Product labeling should also incorporate a patient decision checklist, rupture screening recommendations for silicone gel-filled breast implants, materials description and a patient device card, FDA said.
3. In the U.S., J&J brand Mentor, medical aesthetics company Sientra, breast implant startup Ideal Implant and AbbVie-owned Allergan all still sell breast implants, although FDA asked Allergan to remove certain textured implants from the U.S. market last year after linking their particular surface technology to a higher rate of cancer.  What do you guys think of this ruling?  Do you think it’s enough or does more need to be done? Comments Below: 👇🏻👇🏽👇🏾👇🏿 by @busteddoc
25
6 years ago
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We are coming out of our homes to film and doing it safely!! So many exciting things in store.  This month we will be in Florida, filming the legal side of the story.  100s of 1000s of women are trying to seek justice for the issues they have suffered and the time they have lost.  One after another their cases have been dismissed, until now...@busteddoc will be there for all the action. #documentary #filming #womandirector #filmingduringcovid19 #staytuned #filmthefight #fightthegoodfight #nevergiveup #busteddoc #busteddocumentary #nothingcanstopusnow #notevencovid #comingsoon by @busteddoc
22
6 years ago
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I am honored to announce that @busteddoc (along with a handful of other amazing films) has been chosen for WIFs 2020 mentor program.  This film explores the risks associated with having breast implants.  It is such an honor to be chosen and I know that my involvement in this program will only further propel the film and help inform the necessary choices I have to make between now and the film’s premiere.  #WIF’s mentor program helps identify emerging and rising women in the entertainment field.  As of today, women account for 12% of all directors in Hollywood, that’s why it’s so important to have programs like #WIF.  Their mission statement on their website states: “WIF advocates for and advances the careers of women working in the screen industries - to achieve parity and transform culture.”  If you want to learn more about WIF go to @womeninfilmla 

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#WomeninFilm #WIF #womeninfilmla #WIFMentoring2020
#womendirectors #womenproducers #womenwriters #womeneditors #womenDPs #womenproductiondesigners #womengrips #womenelectics #womenPAs #mentormentee #film #honored #Busted #documentary #BustedDoc #breastimplantsillness #breastimplants #bii #implantremovalsurgery #stayinformed #biidocumentary #breastcancer #breastcancerawareness by @busteddoc
38
6 years ago
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A list of some of the chemicals found inside an implant.  Saline or silicone, they’re all the same. #Busted by @busteddoc
29
7 years ago
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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. by @busteddoc
9
7 years ago
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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 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 by @busteddoc
18
7 years ago
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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 by @busteddoc
24
7 years ago
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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 by @busteddoc
9
7 years ago
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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
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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 by @busteddoc
50
7 years ago
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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.  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.”
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All of this begs the question, are breast implants safe?  In the end, Dr. Rankin decided to focus his practice on breast implant removal until we learn more on why these devices are making women sick. Thank you Dr. Rankin. #BUSTED by @busteddoc
22
7 years ago
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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.
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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.
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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.
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Madris’ data showed hundreds of thousands more accounts of #breast implant harm or malfunctions than had previously been acknowledged.
Thank you Madris. #Busted by @busteddoc
6
7 years ago
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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 turn 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.  Wishing you the best of luck this week, ladies! #Busted @busteddoc by @busteddoc
10
7 years ago
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