Open Letter to Spiro Plastic Surgery Patients
Recently, certain types of textured breast implants have been found to be linked to an extremely rare form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In response, Allergan has recalled all Biocell (textured) surface implants. While the incidence of implant related BIA-ALCL is extremely rare, BIA-ALCL has been found to be approximately six times more prevalent in patients with Allergan Biocell (textured) implants, although the incidence with these specific implants is still extremely rare. This rare type of cancer is still being evaluated by the medical community, and the United States Food and Drug Administration (FDA), and there are many questions still unanswered.
Allergan, upon the recommendation of the FDA, has recalled their Biocell (textured) implants from the marketplace, which means that these implants will no longer be distributed or sold and doctors will no longer implant them into patients. However, as of the mailing of this letter, the FDA is NOT RECOMMENDING THE PROPHYLACTIC REMOVAL OF ANY BREAST IMPLANT.
Patients who have smooth surface implants and who never had textured surface implants or expanders, regardless of fill type (silicone or saline) or manufacturer (Mentor, Sientra, Allergan), likely continue to have extremely low risks of developing BIA-ALCL.
We have always determined which implants to implant on an individual patient basis. This decision is and has always been made in consultation with each individual patient based on a combination of factors, including scientific based research, and aesthetic based recommendations. Implant choice is always a joint decision that is made with each patient at meetings prior to the procedure, and the final decision is always based on best medical and scientific practices in combination with patient preference. We are committed to the process of patient education, weighing risks, benefits, and alternatives widely known and accepted at the time those decisions are made.
Although New Jersey law requires physicians to maintain patient information for seven years, our practice has painstakingly reviewed charts up to 20 years old to retrieve the following information about your implants:
-Your name at the time of surgery
-Your date of surgery
-Implant Style Surface/Shape
In furtherance of our longstanding commitment to the concerns and safety of our patients, we are offering screenings and evaluations to any of our patients who feel there is any suspicious change in their breast implant or breast where implants have been placed. We have always welcomed and continue to welcome back patients for evaluation months and/or years after their breast implant surgery. Now more than ever, we encourage you to address your particular concerns (especially if your implant/breast is changing) with us. The data and recommendations about BIA-ALCL and its management have changed and/or evolved nearly monthly since early this year. We have continually updated our website to reflect as much of this as possible.
If you would like to schedule a follow-up screening or for further information regarding BIA-ALCL, please contact our office during regular business hours.
Scott A. Spiro, M.D., F.A.C.S. & Alexis Parcells, M.D.
August 9, 2019
Regarding THE FDA Update and Recall from July 29, 2019
In follow-up to Allergan’s voluntary recall of unused BIOCELL® products, we created theBIOCELL® Replacement Warranty for all patients currently implanted with BIOCELL® textured implants.
For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL® textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements of a similar size for free. The program will run for 12 months, until July 24, 2020, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.
The decision to get a breast implant revision is a personal decision between patients and their plastic surgeons, and must be decided based on the appropriate discussion of benefits and risks. As part of this program, Allergan will not provide surgical fee assistance to revision patients. This decision is in-line with the FDA and plastic surgery societies’ recommendations not to remove textured implants or other types of breast implants in patients who have no symptoms of Breast Implant AssociatedAnaplastic Large Cell Lymphoma (“BIA-ALCL”) due to the low risk of developing BIA-ALCL. Patients who decide to keep their BIOCELL® textured devices will continue to be covered under the NATRELLE® ConfidencePlus® warranty, which includes reimbursement for up to $1,000 in diagnostic fees and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL.
BIOCELL® Replacement Warranty: Surgeon Frequently Asked Questions:
What is the BIOCELL® Replacement Warranty?
For patients in the U.S. who choose to replace their BIOCELL® textured devices with smooth devices, as a result of the recall announcement on July 24, 2019, Allergan will provide smooth device replacements of a similar size for free.
When does the program take effect and for how long?
This program started on July 24, 2019 and will last until July 24, 2020.
What patients are covered?
Patients must be U.S. based, and they must have a BIOCELL® textured implant. This program is intended to assist patients who, as a result of the BIOCELL® recall, are concerned about their textured implants. Patients should have carefully considered the benefits and risks of a revision surgery through a discussion with their plastic surgeon.
What devices are covered?
The BIOCELL® Replacement Warranty covers all BIOCELL® textured implants that may have been originally manufactured under the brands MCGHAN, INAMED, or ALLERGAN NATRELLE®. Both saline and silicone gel filled textured implants are covered.
Which replacement devices may patients select as part of this replacement program?
Silicone gel-filled texture implant patients are eligible for gel-filled smooth implant replacements, and saline-filled texture implant patients are eligible for saline-filled smooth replacements. Allergan will provide replacement implants of similar sizes and styles, within a similar product type, gel or saline, but the exact material fill or product dimensions do not need to match exactly. For example, a Style 410 (e.g. SKU FM-410-310) textured anatomical implant may be replaced with any similar size NATRELLE INSPIRA® smooth implant containing either Responsive (e.g. SKU SRM-310), SoftTouch (e.g. SSM-310), or Cohesive gel (e.g. SCM-310). Or, a Style 168 textured saline (e.g. SKU 168-300) implant may be replaced with any similar size NATRELLE® Style 68 smooth saline-filled implant (e.g. SKU 68-300). In these examples, all implants have a similar base width, projection, and volume. In some cases, an exact matchup of the device dimensions may not be possible, in which case a similar device will be allowed. The program is not intended to assist patients with reoperations for size changes or correcting non-implant related changes to the breast over time. The BIOCELL® Replacement Warranty is intended to assist patients concerned about their BIOCELL® textured implants as a result of the recall.
Does this apply to all of my revision surgeries for BIOCELL® implant patients?
This program is not intended for all BIOCELL® revision surgeries. The program is intended for BIOCELL® patients who are looking to replace their textured implants with smooth implants as a result of the recall announced on July 24, 2019.
How do I initiate a claim?
You may initiate a replacement request by talking with your Allergan Plastic Surgery Sales representative or by contacting the Allergan Product Surveillance team prior to surgery at 1-800-624-4261. Allergan Product Surveillance will request information about the devices being replaced and devices being requested. Allergan Product Surveillance will also provide a BIOCELL® Replacement Warranty program informed consent document for the patient to acknowledge that she has reviewed her options with you, her plastic surgeon, and has accepted the program conditions. Upon receipt of the signed consent document, replacement devices will be shipped to the specified address, or credited to the account if new products are used from your consignment.
Do explanted BIOCELL® devices need to be returned to Allergan as part of the BIOCELL® Replacement Warranty?
Yes. This process will be the same as other device replacement programs at Allergan. When you open a BIOCELL® Replacement Warranty request with Allergan, we will send a return kit to you and we request that you please send the explanted devices back to Allergan in the return kit.
Are surgery fees covered?
As part of this program, Allergan will not be providing surgical fee assistance to revision patients. This decision is in-line with FDA and plastic surgery society recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of Breast Implant AssociatedAnaplastic Large Cell Lymphoma (“BIA-ALCL”) due to the low risk of developingBIA-ALCL.
Regarding THE FDA Update and Recall from July 24, 2019
“Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.”
Regarding the FDA update from May 2, 2019
A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.
Regarding the FDA update from March 25-26, 2019
The FDA’s General and Plastic Surgery Devices Panel on March 25-26 focused on the topic of MRI screening for silent rupture of silicone gel-filled implants. The panel ultimately made recommendations on MRI screening, suggesting removal of the agency’s current MRI screening recommendations. to instead adopt recommendations that screening begin between five and six years after surgery, and then every two-to-three years after that.
Additionally, alternatives to MRI were discussed, with the panel recommending ultrasound as an acceptable method for screening asymptomatic patients. For symptomatic patients and patient who have equivocal ultrasound results. the panel recommended MRI for detection of ruptures.
Snyder, P. (2019, April 22). Years of collaboration, months of preparation boost ASPS at FDA hearings. Retrieved from https://www.plasticsurgery.org/for-medical-professionals/education-and-resources/publications/psn-extra/news/years-of-collaboration-months-of-preparation-boost-asps-at-fda-hearings
Regarding the FDA update from February 6, 2019
“Though the FDA indicates it has received 39 reports associated with smooth surfaces, to date there have been no confirmed smooth surface-only cases reports to PROFILE.”- excerpt from the American Society of Plastic Surgeons (ASPS), “FDA issues 2019 update on BIA-ALCL”
The anecdotal experience of many plastic surgeons, including myself… (Dr. Spiro)
There are many women who have undergone multiple breast implant surgeries. A significant percentage of these patients do not know the specifics of their implant history. It is suspected that a number of these patients have not only had prior textured surface implants but also did not undergo capsulectomy (removal of the scar layer of the original textured implant), but rather only a simple removal and replacement procedure.
This subset of women who ultimately changed to smooth surface implants without capsulectomy may not have fully reduced their risks of later development of BIA-ALCL. This may in part explain the 39 case reports with smooth surface implants.
FAQ answered by our Society
Q: What if a doctor is recommending textured implants to a patient?
A: The choice of implant type is ultimately a decision between an educated patient and her board-certified plastic surgeon. There may be certain circumstances where a textured implant is recommended for particular patients.
All patients should have a detailed conversation with their surgeon about the risks associated with textured implants, beyond what is published online or in pamphlet. Ultimately, there are instances where textured implants are the best choice for them.
Q: Why would my surgeon have recommended textured implants for me?
A: There are two primary reasons your surgeon may have recommended textured surface breast implants. First is that some data has shown a lower rate of capsular contracture (firm scar tissue formation around the implant). Second, all teardrop or anatomic shaped implants have a textured surface to help hold them in place. Some surgeons believe these implants can offer an enhanced shape for certain patients, perhaps with a reduced risk of rippling.
Q: Does ASAPS recommend against the use of textured implants?
A: The available data does not support discontinuance of textured implants. The best practice is always for the physician to discuss with each patient the known risks and potential complications associated with any procedure. It is important for the patient and her doctor to frankly discuss all options available, and the risks involved.
Q: Should patients have their implants removed because of BIA-ALCL?
A: Since BIA-ALCL has only been found with textured breast implants, smooth implant patients do not need to be concerned. For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA-ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.
Q: Should women with breast implants be screened for BIA-ALCL?
A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.
Q: Is there any assistance available to the patient?
A: The Mollenkopf Aesthetic Breast Reconstruction Fund and the BIA-ALCL Patient Assistance Fund can offer financial assistance to patients. Additionally, Sientra offers to cover lab testing for any seromas associated with their implants.
A Letter from Allergan
December 19, 2018
Dear Valued Implant Customer,
We wanted to update you regarding a recent change to the Allergan breast implant offering in some international markets. For U.S. based customers, there is no change.
After significant discussions with the Notified Body, which is responsible for granting the CE mark, Allergan was informed on December 14th that its CE mark renewals were not complete. As a result, the CE mark expired on December 16th.
Due to this expired CE Mark, Allergan stopped sales of its textured breast implant products in some international markets. Subsequently, Allergan was informed by ANSM, the French regulatory authority, that they are requiring the withdrawal of any remaining supply of textured breast implants in European markets. While Allergan is fully cooperating with the authority on their request, the Company stands behind the benefit/risk profile of our breast implant products and is working to restore international availability as soon as possible. The ANSM request, and this action, is not based on any new scientific evidence regarding these products.
In the meantime, Allergan’s smooth surface devices will remain available in these international markets.
For U.S. based customers, it is important to emphasize that Allergan’s smooth and textured breast implant products remain available. We’ve included below a few comments made by some leading US surgeons that may be of interest to you.
Thank you for your business. Please reach out if you have any questions or concerns.
Jason Hammer MD, DDS Global Lead Plastics and Regenerative Medicine Allergan Medical Affairs
Ben Newcott Executive Director of Marketing, Allergan Plastics and Regenerative Medicine
Letters from our Society
- “Our Aesthetic Society member surgeons always strive to act in the best interest of our patients. There are times when patients prefer shaped implants for breast reconstruction following cancer or for aesthetic breast augmentation. Shaped implants are textured in order to hold the implants in place. It is extremely disappointing to see any regulatory body preventing surgeon access to this unique class of devices especially when the regulatory agency states that it ‘has not identified any immediate risk for the health of women having these implants.’ It is even more disappointing that this body would interfere in a woman’s right to choose what is best for herself.”
W. Grant Stevens, M.D., F.A.C.S
Clinical Professor of Surgery USC – Keck School of Medicine Division of Plastic Surgery Director USC Aesthetic Surgery Fellowship American Society of Aesthetic Plastic Surgery, President Orange Twist, Co-Founder and CMO
- “As a US-based Board Certified plastic surgeon, as well as a Past President of The American Society for Aesthetic Surgery (ASAPS) and The International Society of Aesthetic Plastic Surgery (ISAPS), I continue to believe that surgeons should continue to have access to smooth and textured breast implants. I interact with plastic surgeons and patients in the US and from around the world. We are fully aware of the risks and benefits of using textured devices. We discuss these tradeoffs with our patients during consultations. Sometimes, in some specific cases the textured device can be the best treatment option. “
Renato Saltz MD, FACS
Adjunct Professor of Plastic Surgery, University of Utah Past President, International Society of Aesthetic Plastic Surgery (ISAPS) Past President, American Society for Aesthetic Plastic Surgery (ASAPS) Diplomate American Board of Surgery and Plastic Surgery Fellow of the American College of Surgeons Founder & Chairman Image Reborn Foundation of Utah
Revised February 8, 2019.