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. Here we will talk about the Allergan recall, Dr. Feldman's policy on using textured implants, and what our patients' options are.
First, we'd like to assure our patients that if they currently have Allergan textured implants, we would be happy to evaluate them for capsulectomy and implant exchange to smooth shell implants.The Allergan Recall of BIOCELL® Textured Breast Implants and Tissue Expanders
Why did Allergan recall these breast implant products? Allergan's action is a precaution based on the findings of the U.S. Food and Drug Administration (FDA) earlier this year:
"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."Dr. Feldman's Position on Textured Breast Implants
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. In fact, 99.97% of the implants placed by Dr. Feldman have smooth shells, with only a single patient requesting and receiving textured devices. Having smooth shelled breast implants automatically reduces your risk of BIA-ALCL by at least 90%. In fact, no cases of BIA-ALCL 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-shell-implant patients.
Additionally, Dr. Feldman takes extensive precautions to prevent implant infections and contamination. He is uniquely qualified when it comes to understanding breast-implant infections. 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 that over 70% of breast implant infections 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 are essential.
In addition to very powerful, MRSA-active oral and IV antibiotics, nearly all of Dr. Feldman's implant surgeries are performed in an office surgery suite, thereby avoiding the contaminated hospital environment, and with the same OR team every time. Lastly, all silicone implants are placed with a 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.
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.
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. If you're a patient of Dr. Feldman and have lost or misplaced your card, call or email (email@example.com), and we can send you a pdf-scanned copy of your implant information.