Welcome to Explant or Bust!
Important Allergan & McGhan Textured Saline and Silicone Breast Implant Recall
The FDA finally asked Allergan (formerly McGhan) to voluntarily recall certain textured saline and silicone breast implants that were implicated in causing Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
McGhan implants ARE part of the recall.
Both saline and silicone-filled implants are recalled, because it is the textured surface (not the filling material) that is allegedly causing an autoimmune response which leads to Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC) and other Breast Implant Associated cancers.
Plastic Surgery Foundation Profile Registry
The PROFILE Registry is open to all physicians in the United States who have a patient with breast implants that has a suspected or confirmed case of Breast Implant-Associated ALCL (BIA-ALCL), Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) or any lymphoma or other cancer found in the capsule surrounding the breast implant.
PROFILE Case Submission Form – Report A Case
National Breast Implant Registry (Device Tracking App)
United States Food and Drug Administration (FDA) Textured Breast Implant Safety Communications (links below)
- Allergan (McGhan) Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
- U.S. Food & Drug Administration – What to Know About Breast Implants
- U.S. Food & Drug Administration – Risks and Complications of Breast Implants
- FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
- U.S. Food & Drug Administration – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
- U.S. Food & Drug Administration – Medical Device Reports for Systemic Symptoms in Women with Breast Implants
- U.S. Food & Drug Administration – Labeling for Approved Breast Implants
- U.S. Food & Drug Administration – Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- U.S. Food & Drug Administration – MedWatch Online Voluntary Reporting Form
- U.S. Food & Drug Administration – Things to Consider Before Getting Breast Implants
- U.S. Food & Drug Administration – FDA Strengthens Breast Implant Safety Requirements
- U.S. Food & Drug Administration – FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
- Government of Canada – Health Canada will be Updating Its Safety Review of Breast Implants
- UK Government – Guidance: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Australian Government – Breast Implants and Anaplastic Large Cell Lymphoma Update – Suspended Breast Implant Devices Now Cancelled
- The 2016 revision of the World Health Organization Classification of Lymphoid Neoplasms
Trusted Resources
Breast Implant Safety Alliance (BISA)
Reversing Breast Implant Illness
Knowledge is Beautiful.
Breast Implant Safety Alliance
Take action
Know Your Breast Implant Type and Manufacturer
I strongly recommend going back to your doctor to find out the information about your implants NOW. You should have been given the Medical Device Registration Card at surgery.
Even if it is past the 7 years that the surgeon is required to keep your records (in the US), ASK them before more time passes.
Consider Legal Action
If you are explanting, request the official, legal chain of custody for your implants IN WRITING PRIOR TO SURGERY. My own explant surgeons ignored this request, so follow up immediately after surgery. Ensure that you know who has your implants and where they are being stored. My explant surgeon, at the self-reported third busiest office in the US, did not even know that the hospital laboratory routinely destroys the implants as medical waste two weeks after surgery.
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) Lawsuits
Breast Implant Illness (BII) Lawsuits
Contact: Megan McBride, Esq. PLLC (Attorney at Law)
Telephone: 850-860-1677
Email: mmcbride@mcbrideesq.com
While I am not advertising for Megan, she is one of several attorneys filing class action and individual cases. Megan has been working on this issue longer than many of the attorneys working on breast implant injuries.
Megan filed a class action complaint against Allergan for injuries associated with the increased risk of BIA-ALCL. She is also pursuing individual cases for women who have suffered injuries after July 24, 2019, as a result of recalled breast implants. Individual cases include women who have been diagnosed with BIA-ALCL. Megan is investigating cases against all breast implant manufacturers and is watching the FDA updates closely.
A comprehensive list of ongoing litigation, attorneys filing cases, and legal updates can be found at the following 2 reputable websites linked below. As both of these sites are maintaining up-to-date information, I will not be repeating that information on this site.
Links to Information About Litigation and Attorneys
Latest Posts
Breast Implants / Explant / UpdatesIf you have textured breast implants, the Allergan and McGhan textured breast implant recall can be alarming. Do not panic, but educate yourself. Both saline and silicone TEXTURED breast implants were recalled for their association with Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
If you do not know what type of implants you have, again don’t panic! Take action by contacting your implanting surgeon. Because surgeons are not required to keep your records forever, contact them as soon as possible. Ask if they registered your implants with the manufacturer and get a copy of all warranty and device information.
If you have recalled textured breast implants (SILICONE OR SALINE) from Allergan or McGhan, don’t panic! Keep reading, be aware, stay informed, and be empowered to take charge of your own health. You may wish to begin researching breast explant options, because waiting lists for qualified surgeons are quite long. You may wish to discuss your case with a BIA-ALCL attorney, as well, to ensure that proper procedures are followed.
FDA Textured Breast Implant Recall
On July 24, 2019, the United States Food and Drug Administration (FDA) recommended that Allergan issue a voluntary TEXTURED breast implant recall. Textured breast implants have been associated with an increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. Textured implants from McGhan Medical are also included in the recall.
BIA-ALCL is a relatively rare type of cancer affecting a small percentage of all women with breast implants. Because many women have breast implants with a smooth surface, which have NOT been linked to BIA-ALCL, the overall percentage of all women with implants diagnosed with BIA-ALCL is small. If you have textured implants, your risk of developing BIA-ALCL, while still small, is higher than the overall rate for all women with implants.
A list of devices recalled in the United States from the FDA, can be found here (FDA, 2019c).
FDA Breast Implant Removal Recommendations
From the U.S. FDA website, “For patients who have no symptoms, removal of these or other types of breast implants is not recommended, due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider” (FDA, 2019b). There are surgical risks to explant surgery. At the time of this recommendation, the FDA felt that the risks of surgery were greater than the risk of BIA-ALCL, for women without symptoms.
When did they know about the risks of Textured Breast Implants?
The 2011 FDA Update on the Safety of
Silicone Gel-Filled Breast Implants stated that “Women
with breast implants may be more likely to be diagnosed with anaplastic large
cell lymphoma (ALCL),” (Drugwatch, 2019b, FDA, 2011).
Lawsuits against
Allergan indicate that the company may have been aware of the risk years
earlier, in the 1990’s (Drugwatch, 2019a).
In March, 2019, the FDA heard two days of testimony from
experts (link to FDA testimony video) in the breast implant field. But
in May, 2019, declined to ask for a recall due to the low risk of
BIA-ALCL. In July, 2019, the FDA
took the unusual action of asking Allergan to recall textured breast implants
and tissue expanders after additional data was reviewed (Drugwatch, 2019c). Typically, companies initiate a recall
without the FDA forcing the issue.
Regulatory agencies in other countries had
previously recommended this action. France’s National Agency for Safety of Medicines
and Health Products (ANSM) was the first to issue a ban. Allergan
stopped selling textured breast implants in Europe in December, 2018. Allergan
announced that it would recall and stop the sale of textured Biocell breast
implants in Canada in May, 2019 (Physician’s Weekly, 2019).
Breast Implant Recall Notices
According to the FDA, Allergan mailed recall notices to women with the recalled breast implants in 3 separate notification campaigns (FDA 2019b). I had a nurse from a plastic surgeon’s office tell me that because I did not receive a letter, my implants were not recalled.
However, not all surgeons register breast implants when they are implanted. Women change addresses regularly. And surgeons are not required to keep medical records forever. Not receiving a letter does NOT mean that your implants are not recalled. Find your medical device registration card- if you were given one. If not, call your implanting surgeon’s office and request a complete copy of your medical record.
Breast Implant Recalls in the UK, Canada, and Australia
In the United Kingdom, the UK.gov
website shares guidance for patients and physicians (gov.UK, 2019). The UK
government previously issued 3 Medical Device Alerts regarding the increased
risk of BIA-ALCL in 2011, updated in 2014, and in 2019.
Allergan’s Financial Impact from Breast Implant Recall
Quoting financial analysis in the UK, Reuters speculated that a direct financial impact from the recall would be negligible for Allergan, which announced its sale to AbbVie, Inc. for $63 billion prior to the FDA recall (Reuters, 2019, Wall Street Journal, 2019).
References
Drugwatch. (2019a). Allergan Breast Implant Lawsuits.
Retrieved from https://www.drugwatch.com/allergan-breast-implants/lawsuits/
Drugwatch. (2019b). Allergan breast implant recalls.
Retrieved from https://www.drugwatch.com/allergan-breast-implants/recalls/
Drugwatch. (2019c). Allergan cites rare cancer as reason for
breast implant recall. Retrieved from https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/
Gov.UK (2019). Breast implants and Anaplastic Large Cell
Lymphoma (ALCL): Information for clinicians and patients. Retrieved January 22,
2020, from https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl#history
Physician’s Weekly. (2019). Allergan to recall textured
breast implants in Canada. Retrieved from https://www.physiciansweekly.com/allergan-to-recall-textured/
Reuters. (2019, July 24). Allergan recalls textured breast
implants worldwide. Retrieved from https://uk.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-worldwide-idUKKCN1UJ1N9
U.S. Food and Drug Administration (FDA). (2019a). Allergan
Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL
Cancer. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
U.S. Food and Drug Administration (FDA). (2019b). Medical device recalls: Allergan. Retrieved 2020, January 22, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢erclassificationtypetext=&recallnumber=&postdatefrom=09%2F10%2F2019&postdateto=09%2F12%2F2019&productshortreasontxt=&firmlegalnam=Allergan&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=500
U.S. Food and Drug Administration (FDA). (2019c). The FDA
Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants
and Tissue Expanders from the Market to Protect Patients: FDA Safety
Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue#list
Wall Street Journal. (2019, June 25). AbbVie Strikes Deal to
Acquire Allergan for About $63 Billion: Drugmakers agree to one of the biggest
mergers in the health sector this year. Retrieved from https://www.wsj.com/articles/abbvie-nears-deal-to-buy-allergan-for-more-than-60-billion-11561458504 [...]
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Breast Implant Illness / Explant / UpdatesRegistered Nurse and Breast Implant Illness Survivor, Sarah Phillipe, shares in her YouTube video how BII is not JUST about the breast implants!
Sarah Phillipe, of Reversing Breast Implant Illness, shares how breast implants are a contributing factor to Breast Implant Illness (BII). As Sarah explains, however, breast implants are not likely the one and only cause of BII symptoms.
Like the analogy of the three legged stool, breast implants can be one leg or contributing factor. However, breast implants alone are generally only a piece of the puzzle that is Breast Implant Illness.
We all have individual stories with the common factor of breast implants. We all arrived at this point in our lives with different exposures to mental and emotional stressors, physical stressors, and chemical or toxic exposures.
For some women, breast implants can be the last drop that overflows our body’s bucket of toxicity. For others, breast implants can be the trigger that starts an autoimmune response and develops into BII over time. Sarah cautions about assuming that breast implants are the sole cause of our current health crisis. While explant surgery is an excellent choice, it might not be the miracle that brings about total healing.
I am one of the women who has not had a miracle turnaround following explant. I found the following video to be encouraging, however. It is a reminder to be kind to ourselves in the process.
Be empowered! You are not alone!
Sarah has appeared on numerous podcasts and conferences. Check out the full list at BII Resources – Reversing Breast Implant Illness.
Sarah Phillipe of Reversing Breast Implant Illness [...]
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Breast Implant Illness / Breast Implants / UpdatesBreast Implant Illness symptoms (BII) can be sneaky and confusing for women and their doctors. You may have been brushed off by your doctor or told that your illness is “all in your head”. Symptoms likely appear gradually over time, not immediately after getting breast implants. Breast Implant Illness symptoms can mimic other illnesses and be difficult to diagnose. Medical literature still refuses to acknowledge Breast Implant Illness as a diagnosis and often belittles the patient.
The search for answers can be tiring and expensive, but be persistent. Track your symptoms and keep copies of all medical testing. Stand up for yourself, and keep searching. There are more medical professionals interested in Breast Implant Illness every day. You are not alone!
Summary:
Breast Implant Illness (BII) Is Real, with diverse symptoms affecting thousands of women based on their unique susceptibilities.Some women are not good candidates for breast implants, most likely based on genetic factors.Patients deserve full and accurate disclosure of the risks of implants before surgery.Literature appears to discredit patients, attempts to confuse doctors, and is written to protect implant manufacturers from liability, obscuring their previous knowledge of risks of implants.No implant lasts indefinitely. All implants will eventually come with a decision to explant.Implants can affect health, finances, and family for many years to come.
The following is a list of symptoms associated with
Breast Implant Illness reported by patients and doctors:
Autoimmune
Formation of
autoantibodiesCommon autoimmune
symptoms or diagnoses: Rheumatoid arthritis LupusSjörgen’s syndromeRaynaud’s syndromeGraves diseaseHashimoto’s thyroiditisSclerodermaMultiple sclerosisUlcerative colitis Crohn’s disease
Ear, Nose, and Throat
Tinnitus (ringing in the ears)Sensitivity to soundVertigoOff-balanceDizzinessMetallic taste in
the mouthDry mouthOral thrush (white
tongue)Smell or chemical
sensitivitiesThroat clearingCoughDifficulty
swallowingChoking feeling
Emotional
Mood swingsEmotional
instabilityAnxietyPanic attacksDepressionSuicidal thoughtsFeeling
like you are dying
Endocrine System
Hypo (underactive)
/hyper (overactive) thyroid symptomsHypo (underactive)
/hyper (overactive) adrenal symptomsAdrenal
insufficiencyAnti-diuretic
Hormone (ADH) imbalanceEstrogen/progesterone
imbalance
Extremities
Tingling or numbness
in the arms and legsCold and discolored
hands and feet Muscle twitching
Gastrointestinal
System / Digestive
Gastrointestinal and digestive issuesSudden food intolerances and food allergiesGas and bloatingDysbiosisIntestinal permeability (Leaky gut)Malabsorption of nutrients and/or medication HeartburnGERD
Heart / Lungs
Heart palpitationsHeart pain Cardiac arrhythmiasChest Pains/BurningShortness of breathAir hunger or
hyperventilatingCough
Immune System / Infectious Diseases
New or persistent
infections – viral, bacterial, and/or fungal (candida)Recurring sinus
infectionsYeast infectionsUrinary tract
infectionsSymptoms or
diagnosis of Lyme Disease
Metabolic / Systemic
Fatigue or chronic
fatigueMuscle aches, pain,
and weaknessJoint pain and
soreness Bone painSwollen and tender
lymph nodes in the breast area, underarms, throat, neck, or groinFoul body odorFevers and/or chillsDehydrationChronic neck and
back painPhotosensitivityBurning pain around
the chest wall or breastsSymptoms or
diagnosis of fibromyalgiaChronic inflammationWeight gain or
weight lossEasy bruising and
slow healing of woundsTemperature
intoleranceSlow muscle recovery
after activityLiver and kidney
dysfunction
Neurological / Brain
Cognitive dysfunctionBrain fogDifficulty concentratingWord retrievalMemory lossHeadaches and migrainesSeizures
Sexual/Reproductive
Frequent urinationLow libidoEstrogen/progesterone
imbalance Diminishing hormones
Early menopause
Skin / Hair / Nails
DermatomyositisSkin cancerHair lossDry skinDry hairSkin rashes Nail changes
(cracking, splitting, slow growth, etc.)Skin frecklingPigmentation changes
(darkening or white spots)Increase in papules
(flesh colored raised bumps)Moles and red molesPremature aging
Sleep
Night sweatsInsomnia (inability
to fall asleep)Frequent awakening
Vision
Decline in visionVision disturbances
or blurry visionDry eyesSjörgen’s syndromeEdema (swelling)
around eyesSensitivity to light
https://journals.lww.com/plasreconsurg/fulltext/2019/03001/Breast_Implant_Illness__A_Way_Forward.12.aspx#pdf-link
(Magnusson, Cooter, Rakhorst, McGuire, Adams, Jr., and Deva 2019).
Take notes! Track your own Breast Implant Illness symptoms over time and be sure to keep a copy of any medical tests results. Often you can find blood test results in online medical portals for your doctor. If not, ask for a copy! Make sure that everyone on your medical team is reminded regularly that you have breast implants. They forget, and we forget to remind them.
Take heart! You are not alone, even when it feels that way. For whatever reason you have breast implants, BII is not your fault! There are more and more medical professionals every day who understand that a wide variety of symptoms can be traced to Breast Implant Illness.
Take action! You can begin to research breast explant options. If you have textured saline or silicone implants, check to be see if yours were recalled (Allergan/McGhan Textured Breast Implant Recall). If you do not know what type you have, contact your implanting surgeon’s office as soon as possible. They often only retain records for 7 years. You can also contact an attorney handling BIA-ALCL and BII cases.
Please share this list with the women (and men) in your life who have breast implants. Even if they do not currently have breast implant illness symptoms, they deserve to be informed and aware.
I am not a doctor, and I do not work with insurance companies, but I will link to doctors and insurance navigators. The information on this website has been carefully chosen from reputable sources. The purpose of this website is not to scare or intimidate any women with existing implants or those considering implants. We are here to provide quality information and help you make the best-informed decisions for your long-term health, finances, and family.
References
BreastImplantIllness.com About Breast Implant Illness. Retrieved July 25, 2019, from https://www.breastimplantillness.com/symptoms/Breast Implant Victim Advocacy. Home page. Retrieved July 25, 2019, from http://www.breastimplantvictimadvocacy.com/home.htmlBremen, V. & MedNews. (February 15, 2019). Breast Implants Associated with Host of Illnesses. Retrieved July 26, 2019, from https://mednews365.com/breast-implants-associated-with-host-of-illnesses/?fbclid=IwAR2a6Sk8wR4GtZSCmv2aHFPXp4yD3kfjfmdg6vylDLx7QnH1cRVt1RxG2gcCuellar, M. L., Gluck, O., Molina, J. F., Gutierrez, S., Garcia, C., and Espinoza, R. (1995). Silicone breast implant-associated musculoskeletal manifestations. Clinical Rheumatology, 14(6), 667-72.DiscoverBreastImplantIllness.com Retrieved July 25, 2019 from https://www.discoverbreastimplantillness.com/symptoms-and-educationMagnusson, M. R., Cooter, R. D., Rakhorst, H., McGuire, P. A., Adams, Jr., W. P., & Deva, A. K. (2019). Breast Implant Illness: A way forward. Plastic and Reconstructive Surgery, 143(3S), 74-81. doi: 10.1097/PRS.0000000000005573 [...]
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Breast Implant Illness / Breast Implants / En Bloc / Explant / Mastectomy / ReconstructionWhether you are having a mastectomy, reconstruction, breast implants for any reason, or explant surgery, choosing a board-certified surgeon carefully can impact the rest of your life. The decision to have surgery is emotional, physical, and financial. Before deciding on which surgeon to entrust with your body, do your homework, ask questions, and take your time to get reliable answers. It is important to consider both the surgeon’s qualifications and experience, but also understand the possible surgical options.
Board Certification
According
to the American Society of Plastic Surgeons (ASPS), choosing a board-certified
plastic surgeon is critical, no matter what country you choose for surgery. The
Trust ASPS campaign shares the importance of thorough researching your surgical
options and choosing a qualified plastic surgeon for the safest outcomes (ASPS,
2019). Both the ASPS and The American Board of Plastic Surgery provides a
physician locator at their websites. In
Europe, check the European Board of Plastic Reconstructive and Aesthetic
Surgery (EBOPRAS) website for further information.
American Society of Plastic Surgeons (ASPS) – also includes an international listing (https://find.plasticsurgery.org/)American Board of Plastic Surgery (https://www.abplasticsurgery.org/ModDefault?section=SurgeonSearch)Certification Matters – a grouping of multiple surgical specialties https://www.certificationmatters.org/European Board of Plastic Reconstructive and Aesthetic Surgery (EBOPRAS) http://www.ebopras.org/index.phpThere is also a comprehensive international list of explant surgeons recommended by other patients and carefully vetted by the authors at the Breast Implant Illness website https://www.breastimplantillness.com/explant-surgeons/
Breast Explant Surgeons
Communicate BEFORE surgery
Surgeons who believe in Breast Implant Illness (BII) and understand that implant removal can cause serious health complications will be more attentive to your wishes and careful during explant.
Get the entire surgical plan in writing and read it carefully. Check references and talk to former patients.Read their website, patient literature, and fine print.Ask the right questions (risks, benefits, insurance, procedure, testing for BIA-ALCL, legal chain of custody, etc.).Keep asking questions until you get answers, even if the surgeon and staff become annoyed. Speak to an attorney before surgery to ensure that all procedures, paperwork, and testing is done properly.If you feel uncomfortable about any aspect of the surgery, go elsewhere.
There
are numerous horror stories on the Internet of women who thought they were
having a total capsulectomy only to find out later that the surgeon drained the
implant first or left part of the capsule.
One blogger is faced with her third surgery (paying out of pocket) to
remove pieces of the capsule left behind by her surgeon.
En Bloc and Insurance
There is a much smaller pool of surgeons with the training, expertise, and experience to properly do an En Bloc implant removal. Although many websites state that these surgeons do not take insurance, this is not necessarily true. My surgeons at Midwest Breast and Aesthetic Surgery in Columbus, Ohio, take many insurance plans and are experts in En Bloc surgery. Refer to the list at Breast Implant Illness website, which despite some disgruntled doctors’ complaints, is an impartial review of qualified explant surgeons. Even if you are paying for explant surgery out of pocket, it is extremely important to consider the expertise of the surgeon.
You may be able to travel for surgery and still pay less than you would with a lesser trained surgeon who may cause you to have further complications following explant surgery.
References
American Society of Plastic Surgeons (ASPS). “Trust ASPS: Choose a board-certified plastic surgeon”. Retrieved July 15, 2019, from https://www.plasticsurgery.org/patient-safety/trust-asps
American Society of Plastic Surgeons (ASPS). “Is your surgeon certified?” Retrieved July 15, 2019, from https://find.plasticsurgery.org/
Breast Implant Illness. “Explant surgeons.” Retrieved July 15, 2019, from https://www.breastimplantillness.com/explant-surgeons/
Certification Matters. “Is my surgeon board-certified?” Retrieved July 15, 2019 from https://www.certificationmatters.org/
National Center for Health Research. “Your guide to breast implants and your health: We’re quoted.” Retrieved July 15, 2019, from http://breastimplantinfo.org/newsroom-2/were-quoted/
European Board of Plastic Reconstructive and Aesthetic Surgery (EBOPRAS). “Welcome.” Retrieved July 15, 2019, from http://www.ebopras.org/index.php [...]
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Breast Implant Illness / Breast Implants / Mastectomy / ReconstructionDr. Ergun Kocak and Dr. Pankaj Tiwari, of Midwest Breast and Aesthetic Sugery in Columbus, Ohio, discuss breast reconstruction options after mastectomy.
Drs. Kocak and Tiwari, my explant surgeons, share three breast reconstruction options. Flat closure, without reconstruction at the time, is detailed in a separate webinar by Dr. Tiwari.
The second breast reconstruction option after mastectomy, breast implants, includes a frank discussion about the possibility of Breast Implant Illness. As Dr. Tiwari states in the video, the doctors prefer placing implants on top of the chest muscle. Many mastectomy and cosmetic implant patients had their implants placed behind the pectoral muscle. For some women, capsular contracture and Breast Implant Illness can occur.
Dr. Kocak discusses several options for using natural tissue breast reconstruction options after mastectomy, including DIEP flap, the option they performed during my explant surgery. I will be providing more detailed information on reconstruction options in future posts.
Midwest Breast and Aesthetic Surgery, Columbus, Ohio [...]
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Breast Implant Illness / Breast Implants / Explant / UpdatesBreast implant removal is commonly called ‘explanting the implant’, or explant for short. In the video below, Dr. Ergun Kocak (left) and Dr. Pankaj Tiwari (right), from Midwest Breast and Aesthetic Surgery, discuss the importance of removing the entire breast implant capsule during explant surgery. The doctors discuss the formation of biofilms, or as Dr. Kocak describes them, trenches where bacteria like to hide. This discussion applies to both saline and silicone implants!
Shortly after a breast implant of any type is place in the body, scar tissue called a capsule, begins to form around the implant. If you have Breast Implant Illness, you MUST have the scar tissue capsule removed with the implant intact. In other words, the scar tissue that formed around the implant should be removed without being ruptured or drained.
The gold standard for explant surgery is En Bloc, a specific type of total capulsectomy.
En Bloc Total Capsulectomy
Drs. Kocak and Tiwari are experts in the En Bloc breast implant removal procedure. En Bloc is a specific type of total capsulectomy, which removes both the implant and the entire tissue capsule intact. Breaking the capsule of scar tissue while it is still in your body releases toxins surrounding the implant.
In En Bloc explant surgery, the capsule is removed without disrupting the implant.
Do NOT allow your surgeon to drain the implants first or to remove the implant and then the remaining capsule. This exposes your body to toxins in the capsule and biofilms around the implant. The capsule of tissue and the implant should be removed together without rupturing the capsule. [...]
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Breast Implant Illness / Breast Implants / Explant / UpdatesThe following video on YouTube is testimony to the FDA by Dr. H Jae Chun, MD. Dr. Chun explains why he has chosen to focus his plastic surgery practice on explant breast implants. He shares his views on the conflicting information presented to sufferers of Breast Implant Illness (BII).
If you have saline OR silicone implants with a variety of seemingly unrelated symptoms, please grab a cup of tea and be reassured that it is not in your head. If someone you love has implants, and you are wondering how to help, please listen in and reassure her that there is a solution. [...]
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Breast Implants / Capsular Contracture / En Bloc / ExplantKnow your EXPLANT TERMS! Your recovery depends upon choosing the correct type of explant surgery and a skilled, licensed surgeon with experience. If you have any symptoms of Breast Implant Illness (BII), your health could actually get worse if you choose the wrong surgeon and wrong type of surgery.
For Breast Implant Illness sufferers, the ONLY safe option is En Bloc, a specific type of total capsulectomy. Keep reading to learn the terms you need to memorize!
Explant Terminology to Know
There are three terms typically used in the language of explant surgery. It is extremely important to understand the differences, particularly in the case of Breast Implant Illness (BII).
Capsule refers to the scar tissue your own body makes surrounding the breast implant.
Capsulotomy, Capsulectomy, and En Bloc implant removal all have important distinctions.
CapsulOTomy
The word ending -otomy means “to make an incision or cut into”. Therefore, capsulotomy refers to removing part of the capsule of scar tissue surrounding a breast implant in order to make more space for the implant. This is NOT the proper technique for explant surgery!
This
surgical technique is typically used to modify the scar capsule when capsular contracture has caused the capsule to
shrink and harden around the implant.
See the separate post on capsular
contracture for more information on causes and treatments. This
technique is NOT appropriate for removal of implants in anyone, but particularly
in the case of BII.
Total CapsulECTomy
Capsule refers to the scar tissue surrounding the breast implant. In this case, however, -ectomy means “removal of an anatomical structure”. TOTAL Capsulectomy is the removal of the entire capsule of scar tissue that surrounds the implant.
Beware: Total CapsulECTomy may not mean that the capsule is removed INTACT, which exposes your body to toxins!
En Bloc implant removal is a particular type of total capsulectomy where the entire capsule is removed with the capsule intact! En Bloc is the only acceptable type of explant surgery for women with Breast Implant Illness.
En Bloc Capsulectomy
En Bloc is a French term (think ‘in’ ‘block’). This specific surgery means the surgeon will remove the scar tissue surrounding the implant WITH THE IMPLANT STILL INTACT AND UNDISTURBED. The scar tissue capsule should NOT be punctured during surgery.
En Bloc is the gold standard for any breast implants, either saline or silicone. Removing the intact implant WITH the surrounding scar tissue prevents any chemicals, silicone, and bacteria from being released into your body. If you have silicone implants, your implants are ruptured or leaking, or if your implants are very old, it is extremely important to contain the toxins within the capsule during removal.
What’s the difference?
Total capsulectomy can refer to removing the implant from the capsule FIRST, and then removing the remaining scar tissue that had surrounded the implant. This will release any of the toxins in the capsule into your body.
It is extremely important to remove the scar tissue capsule completely. However, it is equally as important not to allow the toxins within the capsule surrounding the implant to be released into the body during surgery.
If you have had Breast Implant Illness (BII), you should be more specific than total capsulectomy and choose En Bloc if possible.
Do NOT let your surgeon drain the implant or capsule before removal. Yes, this is easier for the surgeon, but YOU will pay the health consequences. Not only would you be exposed to toxins surrounding the implant, but your surgeon should be aware of the possibility of BIA-ALCL.
BIA-ALCL
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a type of lymphoma (cancer) associated with textured breast implants. BIA-ALCL is often accompanied by fluid surrounding the implant. See the Consensus Guidelines on the Diagnosis of BIA-ALCL, linked below.
2019-NCCN-Consensus-Guidelines-on-the-Diagnosis-of-BIA-ALCLDownload
What about adhesions?
If
you have had your implants for more than a few weeks, your capsule may be
adhered to the chest wall and your rib cage. Surgeons who are trained in the En
Bloc procedures and experienced in performing the surgery know how to gently
separate the intact capsule from ribs and muscles. Understanding what your doctor plans to do if
your capsule is adhered is crucial BEFORE you have surgery.
Be
sure to communicate your preferences before surgery, because your surgeon will
need to make decisions while you are under anesthesia. It is possible that your surgeon will find
that your capsule is very thin or potentially adhered to the chest wall. Even in these cases, with the understanding
that en bloc removal is a high priority, your surgeon can work to remove the
capsule without rupture (Feng, 2019; Chen, 2017).
For more information refer to the video from Midwest Breast and Aesthetic Surgery on the importance of removing the entire capsule.
Communicate BEFORE Surgery
Be informed about explant options BEFORE having surgery. Educate yourself before meeting with a surgeon and take a list of questions to your appointment. Have a written plan that includes what might happen in case the surgeon has difficulty removing the entire breast implant capsule. Review the post on choosing a board-certified surgeon who believes in Breast Implant Illness. These doctors will be more careful about protecting your future health from the toxins inside capsules during explant surgery!
If you have textured breast implants, which are part of the Allergan (and McGhan Medical) recall, ensure that your surgeons are aware BEFORE surgery. If you are not sure, be clear that you expect your implants to be analyzed and proper BIA-ALCL testing done if they are part of the recall.
Request the legal chain of custody for your capsules and implants from the surgeon IN WRITING BEFORE surgery. Keep copies for your records. Be vocal and clear about your expectations.
Be Your Own Advocate!
I requested the legal chain of custody for my implants in writing before surgery. My surgeons did NOT request this information when the samples were sent to the pathology lab. My surgeon excuse was his opinion that there would never be a viable lawsuit related to breast implants.
My surgeons also knew in advance that my textured McGhan breast implants and tissue expanders were both recalled, and I had significant clinical symptoms of BIA-ALCL. They still failed to follow the consensus guidelines for BIA-ALCL diagnosis.
The visual inspection report on my capsules and implants had been sent to the surgeon’s office 3 days after surgery. The Physician’s Assistant finally read the report after my fifth request, a full month later. She declared that the report was “fine” and even then did not give me a copy.
She failed to mention that proper BIA-ALCL testing had not been done, in spite of recalled implants and significant symptoms. Although my surgeon wrote in the surgical record that they sent my capsules to the pathology laboratory for CD-30 staining, they did NOT.
When I asked yet again for the chain of custody on my implants, my surgeon admitted that he did not know where my implants and capsules were located or who did pathology testing on his patients. He was completely unaware that the pathology lab routinely destroys implants two weeks after release of the visual examination pathology report. I requested the legal chain of custody from the manager of the pathology laboratory. She could not provide the document, because the surgeon had failed to request it when sending the implants. It would be illegal to make it up later. In fact, my implants were found in the medical waste bin awaiting destruction. They should have been destroyed 5 weeks earlier, while the surgeon’s office was completely unaware and unconcerned.
You MUST be your own advocate and follow up. I assumed that because my surgeon had glowing reviews about himself and his staff on their website that they were attending to details. I was disappointed to find that both he and his office staff belittled me as “an explanter” and harassed me about asking questions. In fact, my surgeon gathered the entire office staff together to make fun of me at my final appointment. His parting shot was that they “only ridicule some patients”. I am eternally grateful for both surgeons’ medical skills. I’d like to think that at some point he’ll realize that encouraging his staff to make fun of cancer patients recovering from yet another grueling surgery (who also pay their salary) is rude at best. And maybe they will all start paying attention to important details of patient care.
If you are planning explant surgery, you may wish to speak to an attorney BEFORE surgery to ensure that all proper procedures are followed. And be your own advocate, even if the surgeon and his staff make fun of you. You owe it to yourself and your loved ones!
References:
Chen, C. M. (2017). “Implant removal.” Retrieved July 9, 2019, from http://constancechenmd.com/implant-removalClemens, M. W., Jacobsen, E. D., & Horwitz, S. M. (2019). 2019 NCCN consensus guidelines on the diagnosis and treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthetic Surgery Journal, Volume 39, Issue Supplement_1, March 2019, Pages S3–S13, https://doi.org/10.1093/asj/sjy331 Feng, L. J. (August 1, 2016). Breast implant removal: Basics (I) . Retrieved from https://youtu.be/V9EngrFPxp0Kita, N. and Very Well Health. “Capsulotomy in breast implant surgery overview.” Retrieved July 9, 2019, from https://www.verywellhealth.com/capsulotomy-plastic-surgery-procedure-2710117)National Center for Health Research. (2019). “Your guide to breast implants and your health: Finding a plastic surgeon to remove your implants.” Retrieved July 9, 2019, from http://breastimplantinfo.org/finding-plastic-surgeon-remove-implants/National Center for Health Research. (2019). “Your guide to breast implants and your health: We’re quoted.” Retrieved July 9, 2019, from http://breastimplantinfo.org/newsroom-2/were-quoted/The Free Dictionary by Farlex. “-ectomy.” Retrieved July 9, 2019, from https://medical-dictionary.thefreedictionary.com/-ectomyThe Free Dictionary by Farlex. “-otomy.” Retrieved July 9, 2019, from https://medical-dictionary.thefreedictionary.com/-otomy [...]
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