The FDA's report in its full version can be viewed here.

 

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

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.

Links on this page:

1. http://seer.cancer.gov/csr/1975_2007/
2. /MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm
3. http://www.nlm.nih.gov/medlineplus/ency/article/001993.htm
4. http://www.fda.gov/breastimplants
5. https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

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Report: Possible RARE Association Between Breast Implant Capsules and Lymphoma

FDA to issue safety signal on ALCL & breast implants     Today the Food and Drug Administration (FDA) issued a communication to inform health care practitioners and the public about a possible association between breast implants and 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 the condition. ASPS has been actively engaged with the FDA on this matter. The Society is collaborating with the Agency to develop a centralized registry to collect more information on existing case reports and any new cases that may be identified going forward. The Agency has posted two resources on its website. The first is a Safety Communication that provides a summary of the issue, recommended actions for physicians and patients, and how to report information to the FDA. The second is a more detailed report of the FDA's preliminary findings and analyses on ALCL in women with breast implants. Following the signing of a Confidential Disclosure Agreement with the Agency, ASPS was asked by the FDA to comment on both documents. Working with both internal and outside scientific experts, ASPS provided extensive comments, some of which are reflected in the final documents. The FDA has provided the following links to their documents: FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings & Analyses The FDA has issued a press release and is conducting a media conference call and stakeholder call today. ASPS is executing an aggressive media relations campaign to represent plastic surgery's view and minimize potential false alarms for patients and consumers. ASPS has posted additional resources for members and consumers on its website.

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Liposuction Q & A with Dr. Karen Horton

1. How soon will I see liposuction results?

The results of liposuction take at least three months, up to a full year, to be evident.  As with any surgical procedure, you can expect some swelling, bruising, numbness and discomfort that will take a few weeks to resolve.

Postoperative tissue swelling, known as "edema", tends to persist in the tissues that underwent liposuction.  Edema feels like firmness and woody texture to the tissue, sometimes with dimpling of the skin and/or a darker pigmentation.  This is entirely normal; edema is the body' s response to injury! (just like a "goose egg" swelling of the scalp with a bad fall). Initially after liposuction, you may in fact gain weight, despite the removal of a few pounds of fat!  This is again due to edema - the body holds on to extra water as part of its injury response.  

Do not weigh yourself for at least a few weeks after surgery, at least until after the bruising has resolved (2-3 weeks).  When bruising is gone, your healing will be well on its way.  You will notice your clothes begin to fit differently (better) after the first three months, and every single month you will notice subtle but significant changes. The results are permanent!

Remember to be patient after having any Plastic Surgical procedure!  Any type of surgery takes up to a year for every last bit of swelling and tissue edema to go away.  Plastic Surgery is an investment in your body.  You will need to continue your regular exercise regime (beginning at 3-6 weeks postop, or when you receive permission from your Surgeon), a nutritious and balanced diet, and healthy overall lifestyle. 

 2. What anesthesia is used with Tumescent Liposuction?

During liposuction, a fluid mixture commonly called "tumescent solution"containing normal saline (sterile salt water), epinephrine (adrenaline) and a local anesthetic (Lidocaine) is injected into the areas of fat that your surgeon has marked for removal before surgery.  Tumescent solution functions to help "puff up" the fat cells for suctioning, decrease bleeding and limit bruising, and to make the area numb both during and for many hours after surgery. 

After the tumescence is infiltrated, it is allowed to circulate for at least 10 minutes in each area.  This is to maximize the "vaso constriction" effect of the epinephrine (to shrink the blood vessels in the fat and under the skin, to help avoid their injury). 

The local anesthetic will keep you comfortable after surgery, although this is not the only method of anesthesia used during liposuction in most cases .Most of the time, you are also fully asleep under general anesthesia, or at a minimum under intravenous sedation so that you do not feel or remember anything during surgery. 

Next, through tiny "stab incisions" that are placed in natural creases of your body, a thin and blunt-ended wand known as a "cannula" is inserted to permanent suck out fat cells.  These incisions are later closed with sutures(stitches), a dressing is applied over each incision, and you are placed in a postoperative compression garment.  The purpose of the compression garments is to limit swelling and bruising, encourage skin contraction, and to keep you as comfortable as possible. 

3. Who can perform Tumescent Liposuction?

Liposuction is a surgical procedure, and should be performed by a specially trained Plastic Surgeon.  Most Plastic Surgeons have completed at least 5 years of surgical Residency at an accredited University, with an additional year or two of subspecialty training.  At least two years, and up to six of these years should be in Plastic Surgery for a Physician to call themselves a "Plastic Surgeon". 

In the United States, it is important to seek out a Board-Certified Plastic Surgeon who is credentialed by either the American Board of Plastic Surgeryor the Royal College of Physicians and Surgeons of Canada (equivalent licensing Boards).  Unfortunately, not all Physicians are Board-Certified. Another good resource is the American Society of Plastic Surgeons (ASPS)and/or the American Society of  Aesthetic Plastic Surgeons (ASAPS).  Entry to these professional societies is limited to Plastic Surgeons who have been in practice for a minimum number of years, are certified by their respective Boards, and are reviewed and accepted into membership by their peers. 

It is up to you, as the patient, to do your homework not only to learn about your surgical procedure, but about your potential Surgeon!  Board Certification is unfortunately not a requirement to obtain a medical license in the U.S.  In Canada and other countries, Board Certification is a rule; a Doctor cannot obtain a medical license without this certification. 

In addition, many non-Surgeons (Family Doctors, Internists, Dentists) or Doctors with other specialties (Oral Surgeons, Ear, Nose and Throat, OB-GYN)take a weekend course on liposuction and begin offering this treatment at a discounted rate to their patients.  Beware!  Just as you would not go to a foot specialist for open-heart surgery, you should not trust your body and your life to a practitioner who does not have the training and experience in the procedure you are seeking. 

Lastly, be cautious of the terminology "Cosmetic Surgeon", and certification and the like.  Nearly anyone can call themselves a "cosmetic" anything -most of the time, it means very little!  The American Board of Medical Specialties (ABMS) and the Royal College of Physicians and Surgeons of Canada (RCPSC) only recognize University-accredited training programs in Plastic Surgeon for certification. 

 Again, be cautious and take your time to research your Doctor the same way you would research your nanny, a new school for your child or a contractor for your home.  There is only one of you, and you are a very valuable commodity!  Be sure to put yourself in the hands of the best practitioner for the job. 

4. How safe is Liposuction?

Any surgical procedure carries with it potential associated risks, such as the risks of anesthesia, early risks of surgery, and late risks.  Safety is always the number one goal!  Most surgeries are performed in the operating room or an accredited out patient surgical facility with appropriate intraoperative and postoperative monitoring to ensure your procedure goes as safely and smoothly as possible. 

For liposuction specifically, possible early risks include persistent numbness of the surgical area ("anesthesia" of the skin) that can last weeks to months, pins-and-needles or electric shock sensations of the skin as the nerves are waking up ("paresthesias"), or sometimes unpleasant sensations("dysesthesias") as a temporary experience.  Bruising is common for at least 2-3 weeks after surgery, and swelling may persist for 3 months or more.

Potential late complications can include uneven contour of the skin or rippling, darker pigmentation of the treated areas, or asymmetries between sides of the body.  Differences between your right and left sides will likely be pointed out by your Surgeon preoperatively.  Although symmetry is always the goal, you may never be an exact mirror image from one side to the other - no one is! 

As long as the procedure is performed by a Board-Certified, specially trained Plastic Surgeon with a great deal of experience in liposuction, the benefits of liposuction usually far outweigh the risks.  You should also be healthy and physically fit enough to undergo surgery and have clearance from your Primary Care Physician before having any elective surgical procedure. 

 5. What areas are most common body regions treated with Tumescent Liposuction?

 Fat deposition is primarily based on genetics.  Every woman' s body is different, and your area is likely a little different from your best friend' s.

 

The most common areas of the body that are appropriate for liposuction are the lower abdomen hips, flanks (sides or "spare tire" area), inner and outer thighs, the upper neck beneath the chin , upper arms and the "butttockroll" (the area immediately below the buttocks). These regions are the trouble spots that most women (and some men) deposit fat and are stubborn to diet and exercise.

Areas that are not appropriate for liposuction include the knees, lower legs, ankles, lower arms, or the face (with the exception of the front of the neck).  These areas are not usual areas where fat is stored, and liposuction in these regions is risky for injury to nerves, tendons, blood vessels, and the skin. Liposuction is also not applicable to internal abdominal fat - the fat that is deposited around the internal organs.  It is also not a treatment for obesity or for weight loss.  Liposuction is for body contouring only! 

6. Can I have other operations with Tumescent Liposuction?

 Liposuction is commonly performed together with other procedures - for instance breast augmentation, breast lift or reduction, abdominoplasty, or a face lift.  So long as the total time under anesthesia is not excessively long (I limit my patients to maximum 8 hours of elective surgery). it is safe to have combined procedures with liposuction. 

 7. How does the Tumescent technique reduce risk of infection?

Vasoconstriction of the blood vessels may slightly decrease the risk of infection, as the blood flow to the area to be suctioned is reduced temporarily during the operation.  However, the risk of infection is very low as a baseline risk for liposuction.  Usually, a single dose of intravenous antibiotics is given immediately before surgery in the operatingroom.  Oral antibiotics are often continued for a few days after surgery to also prevent infection. 

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The SAFETY and science of breast implants and SILICONE!

Most women who come to see me in consultation for breast augmentation have one major question:  "Is silicone safe???" 

I spend a great deal of time and effort in my practice educating women about their options for surgery, and when discussing breast augmentation, I emphasize that all implants, both saline- and silicone-filled, are SAFE.

In fact, silicone breast implants are the most extensively studied implantable medical device in the history of medical devices! 

All breast implants have a silicone shell; the fill material is what differs.  For most of my patients, I recommend silicone specifically, because it can have a more natural look and feel. 

The website breastimplantanswers.com is an excellent resource for women to learn all about breast implants.  I send each woman I see in consultation to this site to do some "homework" and to learn more about this medical device.

Here are some excerpts from the site (I encourage you to also visit the website for additional information):

Silicone is a highly versatile substance that has many medical uses. Different types of silicone have been used for decades in a variety of medical devices, such as pacemakers and artificial joints.

Learn more about the technology and innovation behind silicone and silicone gel-filled breast implants 

Silicone gel-filled breast implants are among the most extensively studied FDA-approved medical devices in existence. In the United States alone, Allergan has examined the safety of silicone gel-filled breast implants in more than 80,000 women.

For more detailed information, please read the complete safety information

The United States Food and Drug Administration (FDA) approved silicone gel-filled breast implants after reviewing a vast amount of scientific data. These data consisted of results from extensive preclinical testing, four years of data on 715 women from Allergan's Core Clinical Study, and a European study that evaluated implant rupture prevalence rates beyond 10 years1. In addition, countless published, peer-reviewed studies and research support the safety of silicone and silicone gel-filled breast implants. The FDA also considered in their decision the opinions of advisory panels made up of outside experts.

Read the Core Study results

Breast augmentation is a personal decision for a woman, and one that should not be taken lightly.  I encourage all women to educate themselves about the safety and science of breast implants before considering any surgical procedure.  

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Safety is key when planning multiple cosmetic procedures

Planning cosmetic procedures on many parts of the body at the same time is often done:

• To reduce the number of anesthetics given for each procedure
• To lower the overall cost for O.R. time and Anesthesia fees
• To have a single recovery period and less overall down-time

However, SAFETY is key in planning ALL combined cosmetic procedures!

Some procedures are complimentary - i.e. breasts and body (tummy), breasts and liposuction on on front of the body, face and neck together, tummy and thigh contouring.

I advise my patients to choose two major body parts to address at one time and to limit it to that at any one time.

Time under anesthesia is another consideration. There is no 'magic number', but the longer the procedure, the greater the overall risk.

Also, selecting procedures on one side of the body only (all on the front or all on the backside) is another simple way to limit the amount of work done at any one time.

Lengthy procedures on more than two body areas at one time increases the time under anesthesia, increases the risk complications (blood clots in the legs or lungs), fluid overload or dehydration, postoperative pain and immobility, and many others.

Lastly, consider the recovery! Ouch!

It is advisable to have some body areas functional and pain-free so that you can get around and peform your activities of daily living safely.

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