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Breast Implants and anaplastic large cell lymphoma (BIA-ALCL) - 2019 Allergan BIOCELL Textured Implant Voluntary Recall Update

First, it’s important to clarify:

  • ALCL is not breast cancer.
  • It’s extremely rare, with a worldwide total of 573 cases ever reported in the 55 year history of breast implants, versus 692 women diagnosed every single day in the US alone with breast cancer.
  • ALCL seems to have a very strong link, if not exclusivity, to textured implant shells.
  • 99.97% of the implants placed by Dr. Feldman have smooth shells; Dr. Feldman has only placed a single set of textured implants.
  • With proper diagnosis and timely treatment ALCL is a curable illness.
  • All woman have a 12.4% chance of developing breast cancer in their lifetime regardless of implants, vs. 0.0033-0.026% chance of developing ALCL
  • The FDA requested Allergan recall all BIOCELL textured breast implants on July 24, 2019
  • ZERO "pure" cases of Allergan implants with smooth shell have been reported as of July 24, 2019
  • Allergan smooth breast implant options remain safe and effective and will continue to be available in the U.S.

"The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market. The FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants - such as those made by Allergan, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. Therefore, at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL."

“In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma. BIA-ALCL is not breast cancer.

At that time (2011), the FDA knew of so few cases of this disease (approximately 30 cases in more than 10-20 million woman with breast implants) that it was not possible to determine what factors increased the risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in women with breast implants.

Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces (approximately 90%) rather than those with smooth surfaces (approximately 10%).”

"A significant body of medical literature has been published since the FDA's 2011 report on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of BIA-ALCL. Current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3,817 patients (0.026%) to a low estimate of 1 in 30,000 (0.0033%) (Clemens et al, 2017; Loch-Wilkinson et al, 2017; De Boer et al, 2018). While the majority of patients who develop BIA-ALCL have had textured implants, and most cases reported in the literature describe individuals who have had textured implants, there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis."   

So all woman, with or without breast implants have a 12.4% (or higher depending upon risk factors) chance of developing breast cancer, versus a 0.0033-0.026% chance of developing ALCL, (or even lower if you have smooth implants) yet no one is proposing elective bilateral mastectomy for all woman, or recalling natural breast tissue! Calculate your risk of breast cancer here. Your odds of being struck by lightning are 1 in 3,000 to 1 in 14,600, meaning your more likely to be struck by lightening than developing ALCL.

"As of the latest medical device reports (MDRs) update, the FDA has received a total of 660 MDRs of BIA-ALCL. The FDA has carefully reviewed the 660 MDRs to remove duplicate reports and to control for MDRs in which a BIA-ALCL diagnosis was confirmed by: a physician, positive pathology/cytology test results, or positive for biomarker CD30 and negative for biomarker ALK. The FDA's additional data analysis identified 457 unique MDRs for BIA-ALCL, including the death of nine patients which may be attributable to BIA-ALCL. However, it is important to note that at the time of diagnosis, patients may have their original breast implants or they may have had one or more replacements."

It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers listed above may change.”

“A significant body of medical literature has been published since our 2011 report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease. Most of the cases in the literature reports describe a history of the use of textured implants. Several recent journal articles explore the risk factors for BIA-ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others. All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”

In addition to the FDA, the American Society of Plastic Surgeons (ASPS) has also been involved. “The ASPS/PSF and FDA are collaborating to conduct research and develop a Breast Implant-Associated ALCL Registry, the PROFILE Registry, to increase the scientific data on ALCL in women with breast implants."

The strongest unifying theme, in both databases and literature is the extremely strong link, or even exclusivity, to textured implant shells. The FDA databank identified 28 cases BIA-ALCL with smooth implants in place at time of diagnosis; however, each and every one, previously had textured implants. That means every case of BIA-ALCL, with record of implant specifics, had textured implants at some point prior to diagnosis!

The leading theory regarding development of ALCL is based on chronic irritation or inflammation in breast pocket, resulting from textured implant shell surface and low level implant “biofilm” infection. Both of these risk factors are currently, and always have been, specifically addressed and thereby mitigated by Dr. Feldman’s implant selection, research and techniques.

The good news is that Dr. Feldman often recommended against, and rarely used textured implants, even going as far as recommending Allergan voluntarily cease sale of macro textured implants in an email to Allergan’s medical director in May of 2017. even going as far as recommending Allergan voluntarily cease sale of macro textured implants in an email to Allergan’s medical director in May of 2017. In fact, 99.97% of the implants placed by Dr. Feldman have smooth shells, with only a single patient requesting and receiving textured devices. This instantly reduces your risk of ALCL by at least 90%. In fact, no cases have been documented with smooth shell implants and no prior exposure to textured devices. Unfortunately, the absence of proof, doesn't guarantee proof of absence, but many more smooth devices have been implanted since 1963. Currently there are ZERO reported cases of BIA-ALCL in "pure" (meaning no prior history of a textured device) Allergan smooth implant patients.

If you have an Allergan Natrelle Saline 68LP, 68MP, 68HP, Natrelle Silicone Classic Style 10, 15, 20, 45, Allergan Natrelle Silicone Inspira SRL, SRLP, SRM, SRF, SRX, Allergan Natrelle Silicone Inspira Soft Touch SSL, SSLP, SSM, SSF, SSX or Allergan Natrelle Silicone Inspira Cohesive SCL, SCLP, SCM, SCF, or SCX  implants these all have smooth shells. This information was on the card you were given after surgery. If you’re a patient of Dr. Feldman and have lost or misplaced your card, call or email the office (info@bfprs.com) and we can send you a pdf scanned copy of your implant information. The overwhelming majority of implants placed by Dr. Feldman are Allergan 68MP, 68HP for saline, and Style 15 (moderate plus profile), 20 (high profile), SRM/SSM (moderate plus profile) and SRF/SSF (full profile) for silicone.

Additionally, Dr. Feldman takes extensive precautions to prevent implant infections and contamination. He is uniquely qualified when it comes to understanding breast implant infections, as he published a landmark paper regarding the bacteriology of breast implant infections, in the world’s largest medical center, Houston’s very own Texas Medical center, documenting over 70% are resistant Staphylococcus Aureus (MRSA). As a breast implant infection was previously known to be breast threatening complication and now may be linked to ALCL, impeccable sterile technique and infection avoidance is essential. In addition to very powerful, MRSA active oral and IV antibiotics, nearly all of Dr. Feldman’s implant surgeries are performed in our AAAASF surgery suite, thereby avoiding the contaminated hospital environment, and with the same OR team every time. Lastly, all silicone implants are placed with Keller funnel to further avoid contamination and skin contact. These exhaustive precautions have been successful in avoiding implant infections, and now will pay further dividends, potentially reducing the risk of ALCL even further, in addition to the smooth implant shell discussed above.

Again, let’s put this all into perspective. Regardless of implants or no implants, 1 in 8 woman or 12.4% of woman develop breast cancer, but no one is in a panic, publishing headlines, about that. 573 cases of ALCL have been reported worldwide out of over 20 million women with implants in the 55 year history of breast implants, with approximately 1.5 million woman receiving implants annually. That’s 0.002285%. 252,710 women are expected to be diagnosed with breast cancer in US alone in 2019, that’s 692 women per day, yes 692 woman PER DAY with breast cancer, which has nothing to do with breast implants.

Recent literature indicates there is a 100% cure rate for those treated without a delay in diagnosis as was the case in the reported ALCL deaths. The key to successful treatment is proper identification of the symptoms, timely diagnosis and treatment. The condition usually presents as, spontaneous, unilateral swelling of the breast 3-14 years after augmentation. It may also present as a lump in the breast or axillary lymph nodes (armpit). Proper diagnosis may include ultrasound and/or MRI. If seroma fluid is present on imaging it should be sampled and sent for cytological laboratory analysis. Definitive treatment includes surgical removal of implant and surrounding capsule.

If a patient currently has textured breast implants and has not experienced any sudden changes in the way her breasts looks or feels, the FDA is not recommending removal, but rather to monitor for changes. Should any changes occur they recommend quickly contacting a board certified plastic surgeon for evaluation.

FDA ALCL FAQ

FDA Letter to Health Care Providers - February 6, 2019

Sources:
https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
https://www.allergan.com/news/news/thomson-reuters/allergan-voluntarily-recalls-biocell-textured-brea
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
http://www.thepsf.org/research/clinical-impact/profile.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm
https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee
https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas

 


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THE ALLERGAN RECALL OF BIOCELL TEXTURED IMPLANTS AND TISSUE EXPANDERS

b2ap3 small Allergan recall 2

This July Allergan announced that it was recalling BIOCELL® Textured Breast Implants and Tissue Expanders. With the recent coverage of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the news, some of our patients are searching for more information about the safety of breast implants. Learn more about the Allergan recall, Bancroft Feldman's policy on using textured implants, and what our patients' options are.

VB, Richmond, TX

"I selected Bancroft Feldman Plastic Surgery for my breast augmentation based on these patient testimonials, and other reviews on the internet. The staff and Dr. Feldman are very friendly, listened to my concerns before surgery, explained how the procedure would be handled, and ultimately delivered a "10" result! I now reccomend them to all of my friends, and would not hesitate to return to their office if I decided to have additional surgery."

MH, Wharton, TX

"I just wanted to tell all of you thank you again.  And by the way I have the best looking boobs ever.  Beyond thrilled!"

KH, Houston, TX

"I just wanted to check in with yall hope everything's great & wanted to thank Dr. Feldman again, my boobs are awesome. I wore a swim suit for the first time this weekend and I've had 6 girls asking who did them because they turned out so fantastic!!"