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First, it’s important to clarify:

  • ALCL is not breast cancer.
  • It’s extremely rare, with a total of 359 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.
  • 99.9% of the implants placed by Dr. Feldman have smooth shells.
  • With proper diagnosis and timely treatment ALCL is a curable illness.

“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.

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%).”

“As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.

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 FDA database identified 359 cases of BIA-ALCL as of February 1, 2017. The FDA acknowledges “the MDR system is a valuable source of information, but it may contain incomplete, inaccurate, untimely, unverified, or biased data.” As such, the ASPS task force created the PROFILE database, which has identified 126 confirmed unique cases of BIA-ALCL as of the most recent report available, and a peer reviewed exhaustive literature review published in 2015 identified 173 cases.

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 and techniques.

The good news is that Dr. Feldman often recommended against, and rarely used textured implants. In fact, 99.9% of the implants placed by Dr. Feldman have smooth shells. 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.

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 (moderate plus profile) and SRF (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.

Let’s put this all into perspective. Regardless of implants or no implants, 1 in 8 woman or 12.5% of woman develop breast cancer, but no one is in a panic, publishing headlines, about that. 359 cases of ALCL have been reported worldwide out of over 20 million women with implants in the 55 year history of breast implants. That’s 0.001795%. 252,710 women are expected to be diagnosed with breast cancer in US alone in 2017, that’s 692 women per day, or double the number ever diagnosed with ALCL.

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 current consensus recommendation of the ASPS and FDA is that no treatment is needed, but rather to monitor for changes. Should any those occur they recommend quickly contacting a board certified plastic surgeon for evaluation.

FDA ALCL FAQ

Sources:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
http://www.thepsf.org/research/clinical-impact/profile.htm

 

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