Welcome, this site contains useful information regarding Breast Implant Illness (BII).
The recovery of a particular illness is going to begin with removing any interference with the body. That is when reversal can occur, not from symptomatic treatment which treats the symptoms but not the source.
Thousands of women with breast implants have developed various symptoms in response to the inflammation (foreign body reaction) and toxicity from their breast implants. They began seeking help from their physician and specialists – many adjust their lifestyles to cleaner eating, less work, various health treatments – without resolve until connecting their symptoms to a systemic response to their breast implants regardless of make or model.
It has been established for the past several decades that the first step in recovery is explant surgery to remove the implants and the surrounding scar tissue known as capsules. Both can be responsible for an autoimmune response, with capsules containing inflammatory cells and having the potential to harbor a breast implant associated cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Why explant without replacement?
- You have many unexplainable symptoms, such as: fatigue, cognitive dysfunction (brain fog, memory loss), muscle aches, joint pain, hair loss, dryness throughout the body, recurring infections, gastrointestinal and digestive issues, rashes, problems with thyroid and adrenals.
- The occurrence of a new autoimmune disease, with or without family history, or have a preexisting autoimmune disease
- The occurrence of new allergies, food intolerances, or chemical sensitivities
- You’ve gone from doctor to doctor and continue to have unresolved health issues
It can help to write down a chronological list of Symptoms from when they first started. You may notice a pattern of how they began after implantation and have only compounded since.
The first step to your recovery is Explant: choose a plastic surgeon that will do full capsule removal (very important) through en bloc or total capsulectomy procedures, ask for all silicone to be removed in case of a rupture or of any gel bleed, have the surgeon take pictures of your capsules and implants during surgery, and have the implants returned to you so you can inspect them. You can also have the surgeon take swabs during surgery and send them to Pathology along with the capsules to check for any pathogens (biofilm, bacteria, fungi), inflammatory cells, and/or malignant cells related to BIA-ALCL (most linked to textured breast implants).
Always do your own due diligence in selecting an Explant Surgeon and prepare a list of Questions to Ask Explant Surgeons. The surgeons on this list are added based on word of mouth women’s recommendations and pictures of capsules and implants to ensure proper explants with full capsule removal (total capsulectomy and en bloc procedures). This website receives no money from any surgeons. The explant surgeon list is regularly updated.
You can try to see if Insurance can cover the surgery.
Explant is the most important step towards recovery by removing foreign body and toxic interference. Following explant you can start Detoxification of the toxins stored in the body due to the overload of toxicity (heavy metals, chemicals, silicone, biotoxins) from the implants. The body is capable of great regenerative and healing potentials when treated properly.
Inflammation & Toxicity
Breast implants are a controversial subject that are still advertised as safe by plastic surgeons, doctors, and the medical community when in fact they cause many health issues. When you hear about breast implants, doctors generally focus on the look and local complications – without disclosing the persistent foreign body reaction, adjuvant effects of silicone toxicity, heavy metal exposure, how the implants release gel bleed, the development of biofilm around implants (causing persistent low grade chronic bacterial infections, chronic inflammation, capsular contracture, etc), and how the implants are oxidized in the body (causing free radical/oxidative damage). These weaken the immune system and result in a systemic cascade of negative health issues, which may include autoantibodies and autoimmune diseases, endocrine dysfunction, thyroid/adrenal problems, gut dysbiosis, bacterial and viral infections, and more. Breast implants consist of two large foreign bodies composed of 40+ chemicals and have semipermeable shells that leak gel bleed of silicone, Heavy Metals, and chemicals from the day they are implanted, causing profound illnesses. These abrasive substances are toxic and inflammatory to our cells and body processes, such as the immune and endocrine systems. The “new and improved” cohesive silicone breast implants also release gel bleed and contain aggressive chemicals and heavy metals. Gel bleed inside the body is like glue. As Scientific Articles show, low molecular weight siloxanes are extremely toxic. Although saline implants may seem as the safer of the two, they are also encased in silicone shells. The FDA refers to these also as “Silicone Inflatable (Saline-Filled) Breast Prosthesis.” Many of them have faulty valve manufacturing defects that cause a leakage and “backwash” effect. Therefore mold can thrive inside saline implants for years, creating biotoxicity, and the health effects are detrimental. Textured breast implants are some the most problematic, they have also been the most linked to causing BIA-ALCL and have been recalled in Europe and suspended in other countries; Allergan by far has the highest number of cases recorded.
1. August 2020, FDA update ‘Medical Device Reports for Systemic Symptoms in Women with Breast Implants’
2. FDA has issued warning letters to all four breast implant manufacturers:
“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. … Allergan’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s premarket approval order.” – FDA
3. February 2020, AZ SB1439 Bill was passed in senate. Effective January 1, 2021, it requires a physician in Arizona to provide a patient with breast implant surgery information as outlined and to obtain informed consent from the patient prior to surgery. This includes an informed consent checklist with information on BIA-ALCL, breast implant illness, National Breast Implant Registry (NBIR), how to report adverse effects to the FDA MedWatch Program, and more.
4. October 2019, FDA released a statement on enhancing breast implant labeling recommendations including: a black box warning, patient-decision checklist, product ingredient information including types and quantities of chemicals and heavy metals, silicone gel-filled breast implant rupture screening recommendations, and updated patient device card. A draft guidance was issued and was open to public comment until December 23, 2019.
5. July 2019, FDA requested Allergan to recall its textured breast implants from the US market. Allergan responded with a global recall of silicone and saline textured breast implants and tissue expanders. This comes after more cases of BIA-ALCL have been reported. See FDA News Release July 2019, FDA News Release August 2019, FDA Medical Device Reports of BIA-ALCL, Allergan Recall, and NCHR. In September 2019, the FDA identified the Allergan recall as a Class I Recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
[T]he 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. As we describe below, 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. – FDA
7. April 2019, wave of regulatory actions as countries (France, Netherlands, Columbia, Canada) move to suspend textured breast implants. Click here to read more.
France is the first country to ban breast implants linked to heightened cancer risk of BIA-ALCL. France bans textured and polyurethane breast implants made by 6 manufacturers: textured Natrelle implants by Allergan; Monobloc textured implants by Arion; Silicone textured implants by SEBBIN; GFX, IMPLEO and COGEL implants by Nagor; MATRIX implants by Eurosilicone; and POLYtxt, Sublime Lime, Microthane and Diagon\Gel® 4Two implants by Polytech. Source: ICIJ 1.
Two days after France, the Netherlands announced plans to temporarily suspend textured and polyurethane breast implants. Sources: ICIJ 2.
Columbia temporarily suspends textured breast implants. Source: El Tiempo.
Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure (April 2019). Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer (May 2019). Source: Health Canada.
8. March 2019, during the FDA public meeting on reviewing breast implant concerns, it was revealed that over 350,000 reports of problems with breast implants from the last decade have been hidden from the public in Alternative Summary Reporting (ASR); where manufactures combined up to thousands of breast implant reports of malfunctions, problems, and injuries into single summaries instead of as individual reports. See Reports of problems with breast implants hidden from public and FDA kept hundreds of thousands of breast implant incidents hidden from public.Click here to read more.
Madris Tomes, a former FDA data analyst and the founder of Device Events, testified at the FDA hearing (go to 6:37:36) as a Data and Patient Advocate and revealed the FDA’s faulty Summary Reporting. She states, “Adverse event data should never be withheld from the public. This hurts both patients and physicians, and ultimately harms the US Health Care System. We all pay when the Manufacturers cannot be held accountable and are protected by the FDA.”
The FDA has stopped using ASRs for most medical devices as of 2017 and is working on making the information available to the public.
10. March 2019, FDA issued warning letters to two breast implant manufacturers (Mentor and Sientra) for failure to comply with post-approval study requirements.
11. December 2018, Allergan textured breast implants (Biocell and Microcell) were denied renewal of their European 5-year safety certificate, known as CE mark, and was followed by a “voluntary recall” from the market. Source: FDA General and Plastic Surgery Devices Panel Meeting, Dr. Mark Clemens (4:42:00). In February 2019, citing the CE expiration, Saudi Arabia also issued a recall of Allergan textured breast implants. Source: Saudi Food & Drug Authority.
Trust your instincts and listen intuitively to your body, it sends you signals through symptoms. Time is of essence to the progression of your health.
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