FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants

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Date Issued: January 26, 2011

Audience:

Health care providers involved in the care of patients with breast implants
Hospital tumor boards
Breast implant patients and families of patients, including those that have received breast implants for aesthetic augmentation, revision, or reconstruction.
Patients considering breast implant surgery
Medical Specialties: Radiology, Pathology, Plastic Surgery, General Surgery, Internal Medicine, Obstetrics/Gynecology, Oncology, Nursing, General Practice

Purpose:

The FDA is issuing this communication to inform health care providers and the public about a possible association between breast implants and a type of anaplastic large cell lymphoma (ALCL). Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. The FDA is also asking health care providers to report confirmed cases of ALCL in women with breast implants to the FDA.

Summary of Issue:

The FDA is exploring a possible link between breast implants and ALCL. ALCL is a rare cancer of the immune system, which can occur anywhere in the body. According to the Surveillance, Epidemiology, and End Results (SEER) Program1 of the National Cancer Institute, an estimated 1 in 500,000 women per year in the U.S. is diagnosed with ALCL. ALCL in the breast is even more rare; approximately 3 in 100 million women per year in the U.S. are diagnosed with ALCL in the breast.

As part of its analysis, the FDA conducted a thorough review of scientific literature published from January 1997 through May 2010. From this review, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature. Some cases have been identified through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers, and it is not clear how many of these are duplicates of the ones found in the literature.

The number of identified cases is small compared to the estimated 5 to 10 million women who have received breast implants worldwide. But based on these data, the FDA believes that women with breast implants may have a very small but increased risk of ALCL. Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.

The table below describes the characteristics of the 34 published cases of ALCL in women with breast implants:

Characteristics of 34 Published Cases of ALCL in Women with Breast Implants

Age (years) Median 51
Range 28-87
Type of Implant Silicone 24
Saline 7
Not specified 3
Time from Implant to
ALCL Diagnosis (years) Median 8
Range 1-23

Reason for Implant Reconstruction 11
Augmentation 19
Not specified 4

FDA’s overview, review of the literature and discussion of these cases can be found in the document Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses2.

ALCL is Lymphoma – Not Cancer of the Breast Tissue. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, the ALCL was generally found adjacent to the implant itself and contained within the fibrous capsule. ALCL is lymphoma, a type of cancer involving cells of the immune system. It is not cancer of the breast tissue.

Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (persistent seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA believes that women with breast implants may have an increased risk of developing ALCL, but also believes any potential risk is extremely low. Due to the rarity of ALCL, the small number of reports, and the incomplete and limited data from these reports, more information is needed to fully understand the possible link between breast implants and ALCL.

Recommended Actions for Health Care Providers and Patients

Health Care Providers:

If you have patients with breast implants, you should continue to provide them routine care and support. ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.

Current recommendations include the steps below. As the FDA learns more about ALCL in patients with breast implants, these recommendations may change.

Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.

Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.

Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.

Patients:

If you have breast implants, there is no need to change your routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, you should follow standard medical recommendations including:

Monitoring your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. For more information on self breast exams, visit Medline Plus: Breast Self Exam3.

Getting routine mammography screening.

If you have silicone gel-filled breast implants, getting periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

If you do not currently have breast implants but are considering breast implant surgery, discuss the risks and benefits with your health care provider. You may also visit FDA’s Breast Implants website4 for additional information.


FDA Activities:

The FDA continues to evaluate all available information to understand the nature and possible factors contributing to ALCL in women with breast implants. In addition, the American Society of Plastic Surgeons (ASPS) and other experts in the clinical and scientific communities have agreed to pursue a collaboration with the FDA to develop a registry to gather additional information to better characterize ALCL in women with breast implants.

While the details of the collaboration are being developed, the FDA is advising health care professionals to test breast implant patients with suspected ALCL according to the recommendations above and to submit findings on confirmed ALCL cases to the FDA. The FDA is also asking breast implant manufacturers to report confirmed cases. The FDA will update the public as new information is obtained.

In an effort to ensure that patients receiving breast implants are informed of the possible link between ALCL and breast implants, the FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and providers.

As part of its ongoing surveillance of all breast implants, the FDA plans to provide an update on the state of the science on silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

How to Report Information to the FDA:

If you are a health care provider and you have identified ALCL in breast implant patients, please file a voluntary report through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program online5, or at 1-800-332-1088.

To help us learn as much as possible about ALCL in women with breast implants, please include the following information in your reports, if available:

The term “ALCL Case Report” in section B5 (Describe Event, Problem or Product Use Error) of the MedWatch form

Patient age, gender, race/ethnicity

ALCL diagnosis: date of diagnosis, anatomic site of ALCL, whether ALCL was primary in this site and pathologically confirmed

Clinical presentation

Detailed pathology findings

Breast implant exposure: date implanted, brand and type of implant (saline or silicone-filled), type of implant surface (smooth or textured), complications, length of time from implant insertion, and history of subsequent revision surgeries

Treatment(s) the patient received

Name, contact information and medical specialty of reporter

All reports to the FDA are strictly confidential and protect individual patient privacy.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The FDA will provide updates as more information becomes available.

Artemis' Stealth

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. . .is not to be underestimated. Her strikes are random. Unexpected. Her aim is impeccable. Depending on her ire, it can be a barrage of excruciating proportions. Or, there are times that her presence is just a whisper, that teases like an ill-intended promise. A promise served hot and always with debilitating resolve.

Random Thoughts from the Heart

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You know I can't let you slide through my hands

Wild horses couldn't drag me away
Wild, wild horses, couldn't drag me away

I watched you suffer a dull aching pain
Now you've decided to show me the same
But no sweet, vain exits or offstage lines
Could make me feel bitter or treat you unkind

Wild horses couldn't drag me away
Wild, wild horses, couldn't drag me away

I know I dreamed you a sin and a lie
I have my freedom, but I don't have much time
Faith has been broken, tears must be cried
Let's do some living after love dies

Rolling Stones

Oops! Where did it Go????

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Have you heard the joke that begins: "...a funny thing happened to me..." ? Well, the joke is on me! Four weeks ago I went through a third round of reconstructive surgery. Part of this round included a nipple grafting. (And yes, it is as icky as it sounds. A real slice, dice, and sew job!)

On Monday, while getting dressed for court I noticed that my coveted little protrusion was gone. I went to the magnifying mirror and closely inspected the area. Yup. That's right Alice, me nipple was gone! And, yes, I did say out loud to myself, while standing in the middle of the bathroom..."CRAP, me nipple is gone." And it was said with an affected East End accent. Then I began giggling uncontrollably. It has taken me days to stop.

Indeed, the only thing that saved me from a particularly exhausting day on the criminal bench was knowing what was missing underneath the black robe!

Well, the joke continued. The next day when I stepped into my shower I saw something kinda funky in the corner. I inquisitively leaned down to inspect further. EUREKA! There IT was. In all ITS gruesome glory.

I unceremoniously rinsed IT down the closest rabbit hole -- the shower drain. Its okay, IT's biodegradable.

More than ever, my thoughts are turning back to the Lotus. And, if I want a nipple that bad, I suppose that I can always buy a truly detachable one from the neighborhood "Adult Shoppe" or Auto Zone*.

The Second Unveiling: The Truth & Consequences About Reconstruction

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The look on my husband's face and the unintentional, yet critical, queries threw me for a loop. I thought boob jobs did not create so much scarring! Why are you so cut-up?

I was not angry or hurt by his spontaneous utterances. They just echoed the incredulous feelings I had been having since December 11 (the most current "slice 'n dice" day). Its not that I did not have an intellectual appreciation of what was going to happen to me. Unlike the amputation (aka mastectomy) it would seem that I was not as prepared as I thought for what the reconstruction and masteopexy was going to truly look like, post-surgery. Yes, the reconstructive surgeon had showed me his book of before and after pictures. And, yes, I did study them. But studying that surreal "coffee table" book was like looking at a police mug-shot book -- blurs of unfamiliar images that don't look like they belong in your personal universe.

Upon reflection, it seems that I had, and still am, spending so much time researching and analyzing my cancer, optional paths for survival, and adjuvant treatments to forestall the recurrence of my cancer, that when it came to the reconstructive portion of my journey I had done just enough research to assure myself that I was in good hands with the surgeon. Then I placed my ladies (literally and figuratively) in his hands.

To respond (versus emotionally react) to my husband's own visceral reaction and questions to seeing me completely unveiled (sans gauze and surgical steri-srips), I went back and got the hard facts for him. . . .

Reconstructive Surgery

Immediately after the full mastectomy of the left breast, the reconstructive surgeon began the process of a two-stage reconstruction (sometimes referred to as "two-stage delayed" reconstruction). After the surgical oncologist finished her amputation (with no skin or nipple sparring), and while I was still under general anesthesia, the reconstructive surgeon implanted a tissue expander. A tissue expander is like a balloon that is put under the skin and chest muscle. (And, no, there is no sugar-coating the pain and discomfort the expander can cause under the chest muscle.)

Every 6-8 weeks thereafter, through a tiny valve under the skin, the reconstructive surgeon injected (with a 2-inch needle) a salt-water solution to fill the expander. The valve was always located with what I thought of as a mini-divining tool. My reconstructive surgeon fondly called it a stud finder!? When the magnet stood straight up, EUREKA, the valve opening was found! I was expanded 3 times (I was aiming for a B+ cup-size).

After the skin over the breast area had stretched enough, the second slice n' dice was done to remove the expander and put in the permanent implant on the mastectomy side. Initially it was only going to be a 2 cm incision for the removal and replacement, but due to my petite size the reconstructive surgeon had to cut about 3.5 inches along the breast, coming in from the armpit. Luckily, this was all done along the existing mastectomy incision. As a result, however, that area continues -- even after 5 weeks post-op, to have sharp pulls and stabs of pain.

In the Interest of Beauty?????

In the interest of aesthetic symmetry (which in retrospect, I am having difficulty reconciling this goal with the visual scarring and painful sensory onslaught I am currently experiencing), the surviving breast underwent a mastopexy.

This was done utilizing the anchor incision technique. An anchor incision is made around the perimeter of the areola, vertically down from the areola to the breast crease, and horizontally along the breast crease. (Think, a nautical anchor shape.) This technique produces the most scarring, and is actually a highly invasive series of incisions used in many cosmetic breast surgery procedures.

While the technique creates a surgical wound comprised of a circular top section, a vertical mid section and a horizontal crescent shaped bottom section, the placement of these incisions allows the reshaping and re-sculpting of the entire breast mound, which is necessary during a mastopexy procedures.

Apparently an anchor incision it is still one of the most widely used and reliable methods of achieving excellent breast lift results to compliment a mastectomy reconstruction. (Yipee skipee!)


Everything comes with a price-tag. Like any surgical wound, the anchor shaped incision carries certain risks and can cause several potential complications. The large size and prominent placement of the incisions make visible scarring a strong possibility. Hence, husband's reaction. Most women who undergo this technique will have permanent scars which will be noticeable on the breast and/or areola. (They do say that the scars start to loose their punk-red coloring after 1-2 years...good thing I am working on a 10-year survival plan!)

Additionally, the anatomical positioning of the incisions also might cause damage to the sensitive neurological, vascular and glandular tissues of the breast. This type of injury (the medical professions descriptive word, not mine) can cause temporary or permanent sensory perception issues in the nipple or throughout the breast. Interestingly, my issue at this time is the sensory assault, not the long-term potential degeneration -- the burning around the incisions, the stabbing pains through the sternum and the electrical-like shocks that emanate from the chest wall (this latter pain good, means nerves are trying to find their way back "home").

. . . . then there's the 3d unveiling to come. . . .

You can decide if you want to have your nipple and the dark area around the nipple (areola) reconstructed. Nipple and areola reconstructions are optional and usually the final phase of breast reconstruction. I've opted. (In for a penny, in for a pound...so why not in for a boobie, in for a nipple!) This is a separate surgery - again done in the interest of the self-propelling concept of symmetrical beauty. It is usually done after the new breast has had time to heal from the second round of reconstruction (about 3 to 4 months).

Tissue used to rebuild the nipple and areola will be taken from my body, either from the newly created breast, opposite nipple (except there's not much there to share), ear, eyelid, groin, upper inner thigh, or buttocks -- where-ever I have it to spare. Six to eight weeks after the nipple is created I will get with the tattoo-artist to match the color of the nipple of the other breast to create an areola facsimile. Truth be told, I have threatened to have a lotus flower done in place of the traditional areola. Husband had a visceral reaction to that statement too! (Hee Hee!)

With that last reaction, I threatened to have the eye of Sauron tattood instead!