Truth about textured breast implants and a rare form of cancer might have been lost in the flurry of the recent news media coverage. This Altiora Plastic Surgery & Medspa Special Edition Blog hopes to clarify three important developments in breast implant news:
1. We want patients to understand the issue of Breast Implant Associated-Anaplastic Large Cell Lymphoma, known as BIA-ALCL.
2. Let us explain the truth behind the recent recall of Allergan’s Biocell textured breast implants.
3. Dr. Orlando Cicilioni has announced in patient’s letters and in recent interviews, “You should know that Allergan Corporation did announce on 7/24/19, a worldwide voluntary recall on all their Biocell Textured breast implants and expanders.”
Through his interview, and this resulting blog, below, he explained why. He lists the truth behind textured implants, BIA-ALCL and the big Allergan Breast Implant recall.
The Truth about BIA-ALCL
First, we want you to know that BIA-ALCL, Breast Implant Associated-Anaplastic Large Cell Lymphoma, is quite a rare form of cancer. And the truth is that it is not actually breast cancer. It is, according to the American Academy of Plastic Surgeons, “a rare and highly treatable type of lymphoma that can develop around breast implants.”
They added, “BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces.”
And, as the FDA recently revealed, the brand most associated with it is a type of Allergan “Biocell” textured breast implant.
The Recent Truth of the FDA Announcement and Textured Breast Implants from Allergan
According to the U.S. Food and Drug Administration (FDA), as of August 2018 more than 230 people in the U.S. and 570 people worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma.
The truth is that it’s time to take this very seriously. The FDA, the manufacturer and the American Society of Plastic Surgeons have done so. And this blog summarizes the up-to-date-truth about BIA-ALCL and condenses it into the facts you need to know.
What is BIA-ALCL Cancer?
The AAPS stated, “This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be from 1 in 1,000
to 1 in 30,000 women with textured implants.” And here is the good news: “When caught early, BIA-ALCL is usually curable.”
- In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant. However, in some cases, it can spread throughout the body.
- At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated.
- In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.
Truth, Textured Implants and Your Letter from Dr. Cicilioni
Out of concern for the issue of truth, textured Implants and BIA-ALCL, Dr. Orlando Cicilioni has been reaching
out to all his patients since 2010. He has sent them much of the information in this blog in personalized letters.
Dr. Cicilioni is also encouraging his breast implant patients to come into his Sarasota office for follow-up checks on their implants and breast health. This blog is simply one more way to reach out and explain the issue to you, whether you are a patient, a friend, a loved one of a patient, or an interested blog reader.
Truth, Textured Implants, the FDA and Allergan: The Recent Story
It is true that Allergan, in response to the FDA, has recalled a specific type of textured breast implant:
1. The Backstory: The U.S. Food and Drug Administration took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that…” Allergan recall specific models of its textured breast implants from the US market due to the risk of BIA-ALCL.
2. The List of Recalled BIOCELL products by Allergan:
As soon as they received the FDA request, Allergan took action to protect patients. The company recalled their BIOCELL textured breast implant products, including:
- Natrelle Saline-Filled breast implants,
- Natrelle Silicone-Filled breast implants,
- Also, Natrelle Inspira Silicone-Filled breast implants,
- And Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
3. Plus–Please Note the Recalled Tissue Expanders: The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction,
- including Natrelle 133 Plus Tissue Expander and
- Natrelle 133 Tissue Expander with Suture Tabs.
4. Why A Recall? The company as well as the FDA believes the recall will ensure that thus far unused products “will be removed from suppliers and doctors’ offices.”
Altiora’s List of Breast Implant Symptoms to Watch
Here at Sarasota’s Altiora Plastic Surgery & Medspa, Dr. Cicilioni stated, “I am not aware of any similar recalls on Mentor Textured implants or Sientra Textured implants at this time.”
He also added calmly, “Please understand that though the manufactures may be starting to recall these devices, the FDA has not, as of yet, come forward to recommend patients have these devices removed if they are asymptomatic.”
This means if you do not have any of the symptoms listed below, and you are maintaining proper breast health habits, the FDA has not mandated the breast implants must be removed.
(Just the same, remember that re-checks are still a good idea, especially on implants as old as 8-10 years.)
Warning: Do Not Self Diagnose!
Remember, likewise, according to experts MD Anderson, “symptoms can vary from person to person.”
Thus, if you have noticed any of the following symptoms, please call your plastic surgeon without delay:
1. One of the most common symptoms is a spontaneous “fluid collection in the breast, developing many months or years after receiving a breast implant.”
2. You might see redness and swelling of the breast around an implant, and you know that is not from an infection.
3. Less commonly, there can be a “Contraction of the scar tissue capsule which surrounds the breast implant.”
We merely offer the list for information. Remember, no online research should take the place of a consultation with a physician.
Know the Truth Behind Your Symptoms
As you might imagine, there are many other diseases and conditions that can cause similar symptoms to our list below. Therefore, do not shrug off these symptoms or ignore them. Implant-Associated ALCL can be a difficult diagnosis for this reason.
The truth is you must not self-diagnose. Just because you have one or more of these symptoms, it does not mean you have implant-associated ALCL. (BIA-ALCL) However, it is also true that any of these symptoms are important to discuss with your doctor.
Know the Truth behind the Allergan Textured Implants—and Other Brands
Dr. Cicilioni added, “It is my understanding that although all three of these manufacturers produced textured devices, there seems to be a higher incidence of lymphoma in patients who have been exposed to Allergan’s Biocell texturing in comparison to the other brands.”
He added, “There may still be some degree of risk associated with texturing from other manufacturers, and this matter is currently still under investigation.”
Sometimes One Picture is Worth 1000 Words
Most patients take a look at various types of breast implants before their surgery. That is why we are alerting you about the appearance of the risky breast implants from Allergan. So, take a look at the photograph below. In a side by side comparison, you can see the difference between a textured and a smooth implant.
On the photo, you see a Mentor implant on the left. Notice it has a very smooth and glossy in texture. But on the right we see the frosted appearance indicating texture on the Natrelle implant.
Thus, if you know you have this type of implant, it’s a good idea to go to your surgeon for a breast check-up, or call Dr. Cicilioni right away. And, as noted above, this is especially important if it has been 8 or 10 years since your breast implant surgery.
A Special Caution from Dr. Orlando Cicilioni at Altiora in Sarasota
From the newest information available from the FDA come several alarming facts, which Dr. Cicilioni recently summarized for the benefit of his patients and all the possible BIA-ALCL patients who might read this blog.
- The incidence of BIA-ALCL seems to vary from one implant manufacturer to another and exact risk factors have yet to be determined.
- At the present time, over all the cases of BIA-ALCL that have been reported, one thing is very clear: Each patient was exposed to texturing at some point.
- And Dr. Cicilioni stated emphatically in a recent interview, “What this means is that even if a woman currently has smooth implants, but previously had textured implants or textured tissue expanders, there may still be some risk associated with this.” And he added, “I do believe that the majority of tissue expanders used in the U.S. for mastectomy reconstruction prior to 2019 were primarily textured devices.”
An Altiora Note: With Any Implants, Women Must Continue Breast Health Awareness
The truth is you get used to your implants and they simply become part of you. And you might be tempted to entirely forget breast health. Remember that no plastic surgeon thinks of breast implants as once-in-a-lifetime appliances. Most plastic surgeons believe you should update your implants about every 10 years.
Ironically, in the case of the current BIA-ALCL health concern, Dr. Cicilioni states, “The average length of time from exposure to the texturing to the development of the condition is approximately 8-10 years.”
He stated additionally, “It does not seem as though there have been any cases of BIA-ALCL in women who have only been exposed to smooth implants during their lifetime.”
The Truth About Diagnosis and Treatment of BIA-ALCL
Dr. Cicilioni summarized three major points about treatment if tests reveal you have BIA-ALCL.
1. He stated, “Though many of the women who have developed BIA-ALCL have been successfully treated with simple removal of the implant and capsule, there have been some women who have required additional treatment modalities.” This could mean you will require chemotherapy or radiation subsequent to the essential surgery.
2. He added the best news about this situation, “Early detection and treatment, as with most cancers, usually leads to a more successful outcome.
3. In many cases, replacement with a smooth surface implant may still be an option.”
A Special Caution from Dr. Orlando Cicilioni …
“Please understand that it is important to have a physical examination rather than just randomly order laboratory or radiological testing. I would be happy to see you for a consultation to review this information and advise you further if you have the time. “
A Promise from Altiora Plastic Surgery & Medspa in Sarasota
Dr. Cicilioni accentuated his letter and this interview with concern for patients.
“I would like for you to be aware of this condition, and if you develop swelling or a lump in your breast, please contact my office right away. I will comprehensively evaluate you and order the appropriate tests to determine if any treatment is indicated.”
Do You Know the Surgical Options for BIA-ALCL?
We caution you that not all plastic or cosmetic surgeons have the expertise of experience to deal with the proper surgical techniques of breast implant and scar tissue removal.
Dr. Orlando Cicilioni actually specializes in procedures such those mentioned below:
Depending on your test results, you and Dr. Cicilioni might want to discuss these types of surgery in your consultation:
- Explantation (removal of the implants,)
- And capsulectomy (removal of the scars tissue that encapsulate the breast tissue and implant.)
- En Bloc Breast Implant Removal (An “en bloc capsulectomy is when the silicone or saline breast implant and its surrounding fibrous capsule is removed together “en bloc.” This is different from another technique, in which the surgeon cuts into the capsule, removing the breast implant, and then, after this, removes the capsule.
Check with Dr. Cicilioni Concerning Your Options
Dr. Cicilioni also specializes in combination surgeries, which you might discuss. For example, on the one hand, you could choose En Bloc Breast Implant removal with mastopexy (breast lift.) On the other hand, you and Dr. Cicilioni might discuss explantation of breast implants with replacement of breast implants with smooth implants.
Depending on your case, you might also have the option of explantation and capsulectomy—with an added, delayed breast augmentation using your own fat (autologous fat grafting).
As he ended the interview for this blog, Dr. Orlando Cicilioni updated patients and friends about his move to Sarasota. Please note the following, especially if you missed or lost his letter:
“I have closed my office in Orlando and now practice exclusively in Sarasota. My former associate, Dr. Frank Stieg, has retired as well. I am welcoming all my previous patients and his, to come for their follow up visits for their breast implants and for maintenance surgeries when needed.”
He added, “For patients who have had breast cancer, health insurance will usually cover those breast implant replacement and revision procedures, although such is generally not the case with cosmetically placed breast implants.”
As always, the doctor and his staff at Altiora Plastic Surgery & Medspa thank you for reading this blog. And a special thanks goes out to you at this time for your attention to this serious and timely issue.
We appreciate your help as we continue to spread the truth about textured breast implants and BIA-ALCL.