BIA-SCC and BIA-ALCL

Breast implant associated squamous cell carcinoma and breast implant associated anaplastic large cell lymphoma are very rare. In fact, the incidence of these disease processes is not measured in annual rates. They are so rare that the case count is measured by the number of cases that have ever occurred in history. Understanding personal risk is important when recognizing this low incidence.

According to the American Society of Plastic Surgeons, there are 16 cases reported in the literature for BIA-SCC ever. In regards to BIA-ALCL, there are approximately 400 confirmed cases in the United States and a total of 1,227 worldwide as of August 2022.

BIA-SCC is a very rare but potentially aggressive tumor that appears to be associated with the scar that forms around any type of implant (knee implant, breast implant, etc), and in the case of breast implants, from the breast implant capsule. Because there are so few cases, it is not possible to determine what factors increase patient risk for BIA-SCC prior to their breast augmentation.

BIA-ALCL is a lymphoma or lymphoproliferative disease process. More information is available here. Below you can review a comparison of these two entities based on an overview from the American Society of Plastic Surgeons. Some information may be technical and more appropriate for your healthcare provider but it also offers the consumer insight into the language you may need to understand the full scope of these disease processes.

What is it?

BIA-SCC
Breast implant-associated squamous cell carcinoma (BIA-SCC) is a very rare but potentially aggressive, epithelial-based tumor that appears to emanate from the breast implant capsule. Pathology shows sheets of squamous cells lining the capsule in nests and bundles. BIA-SCC can exhibit highly invasive properties including spread to lymph nodes, local tissues and distant sites, such as muscle and bone.

BIA-SCC is not a cancer of the breast tissue itself.

BIA-ALCL
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL can exhibit highly invasive properties, including spread to lymph nodes, local tissues and distant sites.

BIA-ALCL is not a cancer of the breast tissue itself.

Lifetime Risk

BIA-SCC
Unknown.

BIA-ALCL
The current lifetime risk of BIA-ALCL varies widely (e.g., estimates of 1:2,207-1:86,029 based upon variable risk with different manufacturer types of textured implants. More recently, cumulative risk over 20 years in breast reconstruction patients implanted with Biocell devices was estimated at 1:100 (Cordeiro et al, 2020).

Age at presentation

BIA-SCC
55.8 years (range 40-81)

BIA-ALCL
55.3 years (range 28-84)

Average length since initial implantation

BIA-SCC
Average length since initial implantation 22.74 years (range 11-40 years)

BIA-ALCL
10.32 years (range 0.08-41 years)

Implant Surface

BIA-SCC
In case reports, BIA-SCC has been reported in patients who have had smooth and/or textured implants.

BIA-ALCL
No cases of BIA-ALCL have been confirmed in patients who have only had smooth implants in case series, case reports or registries. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time. The FDA states that all confirmed cases worldwide either have a history of a textured device or an incomplete clinical history available for review.

Implant Type

BIA-SCC
BIA-SCC has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.

BIA-ALCL
BIA-ALCL has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.

Presentation

BIA-SCC
Delayed seroma (fluid collection), unilateral swelling, pain, erythema, often capsular contracture

BIA-ALCL
Delayed seroma, unilateral swelling, pain, erythema, sometimes capsular contracture

Extracapsular spread at presentation

BIA-SCC
80% at presentation

BIA-ALCL
28% at presentation

Typical Pathology

BIA-SCC
Squamous cells in sheets with varying degrees of atypia and metaplasia and at least one focus of SCC.

BIA-ALCL
Lymphoma with mass confined to single area on capsule.

Diagnostic Assessment

BIA-SCC
Send fluid collection sample to lab for testing of CK 5/6+ protein; p63+; Flow cytometry + for squamous cells and keratin

BIA-ALCL
Send fluid collection sample to lab for testing of CD30+ protein; ALK-; Flow cytometry + for T-cells

Imaging

BIA-SCC
Ultrasound to evaluate for fluid around the implant +/- aspiration; MRI with and without contrast to evaluate capsule to rule out mass; PET-CT for extent of disease, if present.

BIA-ALCL
Ultrasound to evaluate for fluid around the implant +/- aspiration; PET‐CT is performed following a positive diagnosis. Mammograms are not helpful for evaluating lymphoma but are important for the evaluation of breast cancer.

Treatment

BIA-SCC
Official treatment recommendations will need to be based on emerging data. At present, it appears that explantation with complete (en bloc) capsulectomy will provide the best outcomes.

Based on existing case reports, it appears that incomplete resection of BIA-SCC can result in early and/or aggressive recurrence.

BIA-ALCL
In the majority of cases, explantation with complete (en bloc) capsulectomy is curative. Incomplete capsular resection has been associated with both recurrence and significantly lower survival. Rare patients will present with more advanced disease and may require radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL. Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally.

Chemotherapy / Radiation Therapy

BIA-SCC
Patients treated within these cases did not appear to respond.

BIA-ALCL
Responds to Brentuximab plus CT.

Reporting

BIA-SCC
The FDA recommends that any suspected or confirmed cases of SCC, lymphomas, or any other cancers around the breast implant be reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and the device manufacturer. To submit a case to the MAUDE database, which collects medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions, visit www.accessdata.fda.gov.

BIA-ALCL
The FDA recommends that any suspected or confirmed cases of BIA‐ALCL be reported to the PROFILE registry, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and the device manufacturer. To submit a case to the MAUDE database, which collects medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions, visit www.accessdata.fda.gov. To report a case to PROFILE, go to ThePSF.org/PROFILE.

Patient Counseling and Informed Consent

BIA-SCC
BIA‐SCC should be discussed with any patient considering breast implants as part of the informed-consent process.

BIA-ALCL
BIA‐ALCL should continue to be discussed with any patient considering breast implants as part of the informed-consent process.

American Society of Plastic Surgeon/Plastic Surgery Foundation Recommendations

Prior to implantation of any breast implant, plastic surgeons should provide patients with the manufacturer’s patient labeling, the FDA-required patient decision checklist and any other educational material to best discuss the benefits and risks of breast implants.

Preoperative workup is essential. All patients presenting with a late seroma should have fine needle aspiration (FNA) and cytology testing. Specimens should be sent for immunohistochemistry including CD30, ALK, CK 5/6, p63 and flow cytometry to look for T-cells, squamous cells and keratin.

All patients presenting with a late seroma should undergo a breast ultrasound and MRI with and without contrast. If disease is confirmed, a PET-CT should be considered prior to surgical intervention. A thorough preoperative work-up allows for potentially the most appropriately planned, single-stage surgery with the greatest chance of success for cure.

Consider the possibility of BIA-ALCL, BIA-SCC and other lymphomas when treating a patient with late-onset, peri-implant changes. If you have a patient with suspected BIA-ALCL or BIA-SCC, refer them to experts familiar with the diagnosis and treatment of BIA-ALCL and BIA-SCC.

At surgery, collect fresh seroma fluid, representative portions of the capsule, and specific pathology requests to rule out both BIA-ALCL and BIA-SCC.

Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers, as well as Cytokeratin 5/6 (CK 5/6) and p63.

Flow cytometry should include instructions to look for T cells, squamous cells, and keratin.

All confirmed or suspected BIA-SCC data should be entered into the PROFILE Registry (Data entry mechanism forthcoming).

Data for all patients with seroma should be entered into the National Breast Implant Registry (NBIR).

Click here for the original blog post written by Dr. Jonathan Kaplan for BuildMyHealth.

The post Update on Breast Implants first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

The smaller the better

With bigger implants, the patient may get stretch marks. Bigger implants also stretch out the breast pocket, meaning it can extend into the armpit area or go across the breast bone, forming a uni-boob!

Bigger implants also don’t look very natural. That may be what some patients are looking for but later in life, bigger implants can lead to a need for reduction.

Smaller implants look more natural, less likely to stretch skin and less likely to end up in the armpit. When you go in for your consult, consider this!

Video: Breast augmentation with smallish implants!

To check pricing on breast augmentation from Dr. Kaplan, click here.

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post Breast implants: the smaller the better! [video] first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

Textured breast implants

First, this doesn’t apply to all implants. It doesn’t apply to saline or silicone implants with a  smooth surface. This doesn’t apply to textured implants by Mentor or Sientra. This is only in regards to textured breast implants specifically made by Allergan.

So what’s the problem?

Allergan textured breast implants are associated with anaplastic large cell lymphoma (ALCL). It’s not your typical breast cancer. In fact, ALCL can occur anywhere in the body. But when it comes to textured implants, the scar tissue around the implant can turn into ALCL.

A patient would be suspicious if one breast all of a sudden grew larger because of an accumulation of fluid around the implant. If that happens, tell your doctor. They’ll remove some of that fluid and send it to the lab for diagnosis. The treatment is to remove the scar tissue that contains the lymphoma from around the breast.

With quick diagnosis, the patient can be cured with removal of this scar tissue.

Why texturing in the first place?

Textured implants help keep an implant in position within the breast. This is less important with a textured round implant because if it spins in the breast pocket, it’s still a round implant and is still in a good position. But a shaped or tear drop implant that spins can create a “sideways” boob. Texturing helps the implant from spinning. To completely avoid the issue, your best bet is to get a round smooth implant since you can’t get shaped or tear drop implants that are smooth.

What if I have textured implants?

If you’re not having symptoms, you don’t have to do anything. Even the FDA is not recommending patients remove their textured implants without symptoms. But again, if you do have symptoms, a cure is likely with removal of the implant and the surrounding scar tissue.

Video regarding textured breast implants and the risk of ALCL

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post Allergan removes textured breast implants from market [video] first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

1. They cause cancer

Breast implants don’t cause the typical type of breast cancer that the vast majority of women have. A very rare form of cancer known as lymphoma, which is more of an overgrowth of lymphatic tissue like lymph nodes that can occur anywhere in the body, can also appear, under certain circumstances, around a breast implant.

Specifically, implants with a textured surface, as seen in shaped or tear drop implants, may result in a very small risk of anaplastic large cell lymphoma (ALCL). This arises in the scar tissue that naturally forms around all breast implants. And within that subset of patients with textured implants, there are patients that have a certain brand of implants (Allergan), that may get ALCL. It can been seen in other brands of textured implants but they’re most commonly seen in that brand.

A patient may notice months or even years after surgery that they suddenly get a fluid collection around their implants. That fluid can be sent to a pathology lab that can diagnose ALCL because of specific proteins found in the fluid. The treatment is to go in and remove the scar tissue around the implant and the implant itself and this usually leads to a cure. So while breast implants can cause a type of cancer, it’s not “breast cancer.”

2. You have to change them out every 10 years

Simply not true.

There are multiple studies that review implants over the course of 10 years and find that a follow up surgery is necessary in about 20% of patients at 10 years. But that means 80% of patients are fine. So if you’re not having any issues with your breast implants, you don’t have to change them out after 10 years, or maybe ever.

3. You have to get shaped/teardrop for them to look natural

Here’s a little secret. Yes, teardrop or shaped implants have less fullness at the top portion of the breast to make them look more natural. But if you don’t get huge implants (round or shaped), they’ll look natural either way!

Go big or go home isn’t true when it comes to breast implants!

4. You can’t breast feed afterwards

Not every woman can breast feed but this has nothing to do with breast implants. So if you’re theoretically or actually able to breast feed before breast implants, you’ll be able to breast feed after breast implants.

5. The silicone can leak into the body

It’s important to make the distinction between older and new implants on this point. Older generation implants that ruptured have been shown to leak silicone molecules to the armpit region and even the liver. But newer implants, as discussed in this document submitted to the FDA, don’t leak into the body. They may leak out of the implant’s silicone shell but they stay contained within the scar tissue around the implant.

To reiterate, scar tissue naturally forms around any foreign object in the body – knee replacements, pacemakers and even breast implants. And this means all breast implants – saline or silicone. So when an implant ruptures and the silicone gel leaks out of the implant, the document above reports that none of that silicone leaked out of the scar tissue surrounding the implant.

Video: The 5 myths about breast augmentation debunked!

Click here to check pricing on breast augmentation from Dr.  Kaplan (aka Dr. Bae)!

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post 5 myths about breast augmentation debunked [video] first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

Important to remember these things after surgery

Regardless of what type of surgery you’re having, the incision will always have a little redness immediately adjacent to the incision. That doesn’t mean you have an infection. If the redness is spreading a large distance away from the incision, or there’s is thick white or green drainage, that’s a different story!

But if there is redness around the incision with light drainage, that may be a sign of inflammation, not infection. In that case, monitor it closely and contact your doctor if you continue to be concerned.

Also, with the prevalence of smartphones and cameras these days, take a quick photo and email or text your doctor, the area of concern. You don’t have an email address or cell number for your doctor? That’s a different problem and should be addressed before surgery! Good communication is key.

One question we get a lot after liposuction relates to firm noodles you may feel under the skin. During liposuction, most of the fat is sucked out of the body and into a canister. But in some cases, fat is pulled away from it’s blood supply but doesn’t get completely sucked out. Since that fat no longer has a blood supply, the fat will die. Dead fat turns into firm, calcified nodules. But don’t worry! It’s not permanent. The fat will eventually be reabsorbed by the body and the area will soften.

Bruising after surgery

No surprise here but you will have bruising after surgery. It’s completely normal but if it’s the first time you’re having surgery, you may worry that some bruising is too much bruising. It’s hard to know when it’s “too much” but there will be some. And it will turn from a purple to a yellowish color over time and will even track far away from the operative site. Totally normal in most cases.

High riding breast implants

While your doctor probably told you before your breast augmentation, you may forget. But your implants that seem really high after surgery, will drop…I promise! Give it about 3 months for implants to settle in their final position.

If you have other questions, contact your doctor.

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post Don’t freak out about these things after surgery first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

What does a breast augmentation revision entail?

A breast augmentation revision can mean many things. First it depends on what the problem is. Did the implants bust or leak? Then a revision would mean an exchange of the old implants for the new implants. But then you have to decide, do you go up in size, switch from saline to silicone or silicone to saline? If you’re going down in size then you’ll need a lift to remove excess skin so the breasts don’t look deflated with the smaller implants.

In the video below, the patient was actually happy with the existing size of her implants (300cc). But she was unhappy about other things. As you’ll see in the video, she had a great deal of ptosis (droop) in the right breast. The other thing, which you can also see in the video, was rippling, a common undulation of the skin caused by saline implants.

Breast lift, capsulectomy, implant exchange

So when you review her concerns – droop of both breasts (right greater than left) and rippling – it’s clear what a revision means in her situation. She needs to remove excess breast skin to perform a breast lift to correct the droop. The rippling can be corrected by exchanging the saline implant with a silicone implant (but the same size implant).

She could also feel the implant on the undersurface of the left breast really easily. This was due to very little tissue between the skin and the implant. This was corrected during surgery by closing off the implant pocket with breast tissue so there’s more breast between the skin and the implant.

One additional issue that was apparent during the operation was the formation of thick scar tissue around the implant. This scar tissue is referred to as a capsule. When the scar is thick and can deform the breasts, that’s capsular contracture. The capsulectomy was included with her procedure as you’ll see below.

Video review of breast augmentation revision

To check pricing on breast augmentation revision from Dr. Kaplan, click here.

Click here for the original blog post written by Dr. Jonathan Kaplan for BuildMyBod.

The post Breast Augmentation Revision [video] first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.