Rebirth of the Women's Plastic Surgery blog

Posted by admin on Sunday, January 8, 2012

There has been a long hiatus in the posts on the Women's Plastic Surgery blog.  The new website for my practice is nearly complete, and I will be starting to blog again about the following topics:
  • Plastic and Reconstructive Surgery
  • Aesthetic Surgery
  • Non-Surgical Aesthetic Procedures - Botox, Dermal Fillers, "Laser" Procedures
  • Medical-Grade Skin Care
  • Health, Wellness and Beauty
  • Women's Health Issues
  • Breast Cancer and Breast Reconstruction
  • Reconstructive Microsurgery
Blog posts will be linked to and featured on my site.  

Until then, please visit my Twitter feed for regular tweets about these topics!

Karen M. Horton, MD, MSc, FACS, FRCSC
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FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants

Posted by admin on Wednesday, January 26, 2011

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
  • 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)Median51
Type of ImplantSilicone24
Not specified 3
Time from Implant to
ALCL Diagnosis (years)
Reason for ImplantReconstruction11
Not specified4

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.
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.

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Report: Possible RARE Association Between Breast Implant Capsules and Lymphoma

Posted by admin

PSN Special Bulletin
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:

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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American Society of Plastic Surgeons | 444 E. Algonquin Road | Arlington Heights | IL | 60005-4664
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Repost of a wonderful article by a Mommy Makeover patient!

Posted by admin on Tuesday, December 28, 2010

This is a WONDERFUL article written by a woman who has had a "Mommy Makeover" surgery.  

Although I wish I could boast about this being MY patient, it is not.  She is an excellent writer and I feel she sums up her experience in a lighthearted and sincere manner. 

However, I truly believe that anyone considering this type of surgery could benefit from reading this in order to help prepare for their experience!

Karen M. Horton, M.D., M.Sc., F.R.C.S.C.

10 Things I wish I'd known before a Mommy Makeover

10 Things I wish I'd  known before a Mommy Makeover After getting a mommy makeover, I came up with a top 10 list of things I wish I knew ahead of time!

1. Guilty as charged.

As most moms do, I tend to put everyone else first. A lot of times that is why women tend to feel like they have lost their identities. It’s hard to spend that much money on yourself, especially for aesthetic reasons. It seems okay to spend it on a car or a trip, but for some reason the thought of spending that money on your body is frowned upon. To some that may seem vain or boastful. For me it was about a self confidence that I had yet to achieve, a love of self that I have longed for my entire life. When I look in the mirror I like what I see now. When I feel good about myself…inside and out…I am a better woman, a better wife, and a better mom. It is absolutely normal to feel guilty about spending money on a mommy makeover and it is okay to finally put yourself first. It is the best money I have ever spent…just ask my family.

2. What to tell the kids.

This was a big one for me. I am a mom of two young girls (5 and 2). I grew up with a horrible body image and the last thing I wanted was to implement that to my daughters. I was concerned about what to tell the oldest, the two-year-old really didn’t understand. I thought about saying, “Well, you and your sister ruined my body while I was pregnant with you both.” But then I thought maybe that was too harsh. (Note the sarcasm). I have tried really hard not to down myself in front of them, calling myself too fat, or commenting on my huge belly. They see me exercise and make healthy choices, but I didn’t want them to know that I didn’t like my body. So I tried to keep it simple. The day before surgery I told my oldest daughter that I was going to have an operation to fix my tummy (I didn’t go into the whole booby thing). She of coursed asked why, I told her because the doctor said so. I was prepared for more questions but she seemed satisfied with that. I was informed by the ladies on this site that the best thing to do with boys, if they are older, is tell them you are having female surgery. They will shut right up and have no more questions. Nothing is more embarrassing than talking female issues with your mom.

3. I’m a big girl now.

Most mommy makeovers include lipo and a tummy tuck. Which probably means you will be lucky enough to wear a skin-tight crotchless compression garment. I, as most women, chose to wear panties over this outfit so I didn’t feel as it all my “stuff” was being squished out. (Think of baboons….ewww, or don’t.) Now, the tricky part here is the first couple of days after surgery. You will spend quite a bit of time on the toilet the first time you try to pee, similar to what it is like after giving birth. After a couple tries, it gets better. However, when you are taking pain medication and muscle relaxers on a regular basis, your mind may be fuzzy a bit. I had the great luck of forgetting I had those panties on and peeing straight through them…twice. Yes, not once, but twice. I was starting to think I might have to revert back to diapers but I graduated and learned how to use the potty like a big girl. Also, you will probably not poop for several days at first, so expect a good 3-5 days worth of poop on your first time. With that being said, consider pulling your garment down for that endeavor. The back to front wiping thing can be tricky in that thing. I’m just saying, not that it happened or anything…..I’m just saying…okay…next subject please.

4. Hello Dolly!

If you decide to get implants please remember that objects may appear larger than they actually are. When I first took a glance at my new girls, I thought “Holy Mary Mother of God, what have I done?!” I looked like Dolly Parton, or for younger ones, Beth from Dog the Bounty Hunter. This is NOT your final look. Please don’t freak out. The swelling takes a while to go down and for the implants to “drop” into place. After about a week your PS will probably give you the go ahead to start massaging them. Massaging the implants will help them soften up and find their final resting place. Your significant other with love this, and surprisingly, so will you. I was shocked to find how much I actually liked touching my own breasts. It sounds perverted, I know, but if you are used to your “ladies” hanging out down by your belly, then you will see how nice it is to hold them, let go, and be fascinated that they no longer fall down so low anymore. I can now understand why men are always holding onto their own “boys”. They are proud of them. I have caught myself with one hand on the remote and the other on one of my breasts. So relax, and let the boobs fall where they may.

5. Phantom of the itch.

I knew going into the tummy tuck part of the mommy makeover that my belly would be numb. It is a freaky and strange feeling. It is almost like you are rubbing on someone else’s tummy. I had heard before about people who have had an arm or leg amputated and still felt the feeling of it being there, the phantom limb syndrome. I was not prepared for that with my belly. Every now and then, I will get an itch, go to scratch it, and realize it is where my belly is numb. Scratching a numb belly doesn’t relieve the itch. Simple right? Well I have a masters degree and it took several times scratching before I got that one.

6. Sit. Stay. Good girl.

Once again, most mommy makeovers include a tummy tuck. This is a huge procedure and as most of you have surely read, it is a good idea to take off as much time as possible from your job. I was fortunate enough to take 2 weeks off from my PAID position. I capitalize paid, because as all moms know, the mom position is considered a “non for profit” position. Rarely do we moms put in a request for vacation from that position, so therefore we tend to work every day of the year, even if we are taking a vacation from our “paid jobs”. As most moms, I am an expert at multitasking. It was killing me to sit there and not do anything. The first 3 days or so you have no choice, your body will not allow it. I will admit that I probably did more than I should have. Looking back, I wish I would have taken more advantage of the quiet time and rested and relaxed. I was convinced that if I didn’t do it, it wouldn’t get done, and it wouldn’t get done right. I was wrong. Trust your loved ones. My husband was amazing. He became Mr. Mom and was pretty darn good at it. I have never given him enough credit in that department. Granted, it may have not been done the way I do it, but he stepped up and took charge. And if you don’t have someone doing those household chores….so what. Just take this time for yourself and give your body a chance to heal.

7. All aboard...the Bi-Polar Express.

This is a BIG one. Having your body cut upon, stitched up, and hung up to dry is traumatic. Throw a few pain meds into the mix and you will turn into an emotional tornado. I was known to go from ecstatic to tears in 6.9 seconds flat. Top that!! Be aware that this will be an issue, and emotions will be crazy. Explain this to your loved ones and the people caring for you so they don’t call the men in white coats with the strait jackets. When I felt teary, I would cry. It’s ok, you have a permit to go crazy, take advantage of it. When I was feeling really down and out, I typically would go to bed and nap it off. Use this site. is full of women who are going through the same thing. Use them to lean on and talk to. The ladies I have met on here have been A HUGE support to me and I couldn’t have gotten through this without them. Well, I would have, but I would have probably been divorced and sitting in a mental institution. Thanks Ladies!!!

8. Let's get physical.

Most people who are looking into plastic surgery are doing so because exercise has not been effective on certain areas of the body. There are only so many chest flies one can do before you realize they won’t make your boobies stand up and say hello. However, there are some who think this is the alternative to diet and exercise. If that is you….you are wrong. I truly believe my fitness level aided in my recovery time. And I know that I will have to work twice as hard to keep my new body looking tip top. The more active and healthy you are before surgery, the better your recovery will be. You will heal faster, feel better sooner, and be back to the gym before you know it. As you heal, stay away from processed and salty foods, soda, and fried foods. You will swell like the Stay Puff Marshmallow Man and be so uncomfortable. When your doctor says its okay, get back into exercising and let your body lead the way. It will tell you what is too much and when to quit.

9. Don't be naive: do the research.

When I decide to do something I go full speed, head first. In this case, you need to know what you are getting into. When I began this journey, I had no idea that there was a difference between a Board Certified Plastic Surgeon and a Board Certified Cosmetic Surgeon. Now, I will not step into the argument of who is more qualified; just know who you are dealing with. Ask around; find people who have used him/her. The doctor will give you referrals, but let’s face it; they are not stupid enough to give you someone who is unhappy with their work. If you know anyone who has had plastic surgery get as much info from them as possible. There will always be someone who is unhappy with a certain PS or procedure they have had done. But there is a HUGE difference between a “well, I just didn’t like his/her bedside manner” or “I just didn’t see a huge difference in my lipo” and the “he completely disfigured me”. Be wary of the flashy salesman. Go with your gut and ask LOTS of questions. The good ones will sit with you and take as much time as needed.

10. Avoid the Debbie Downers.

We all know one….the Debbie Downers, the buzz kill. And most of us will have to deal with a few after surgery. It is really hard when you feel that you don’t have the support from your loved ones. The choice to have a mommy makeover is strictly yours and hopefully you are doing this for you and only you. I have had a few family members of mine that I surprisingly haven’t received support from. It is hurtful, especially since they saw me struggle with my weight and self esteem issues for years. A lot of people will see it as a “waste of money”. I started feeling the need to explain my reasoning for having the surgery. I wanted them to know that it was not out of vanity, or selfishness. But remember the old saying “Those convinced against their will, are of the same opinion still.” It really doesn’t matter. As much as I wanted them to hear me out and understand my reasoning, they won’t. If they love you, they will keep their negative comments to themselves and support you no matter what. But you may have those who love you yet still feel the need to give their opinion even when not asked. My response to those people would be a nod and a smile. (Believe me, I know it’s hard) If you want, throw in a “please keep your negative comments to yourself” or a “if you don’t have anything nice to say…”. But my advice is to steer clear of the “screw you” sort of comment. It is just not worth it. As long as you know why you are doing this that is all you need. For me, being able to look in the mirror, smile and for the first time in my life, love what I see…well that is priceless to me. And for those who can’t see past the money or their opinions, they are missing out on watching someone they love transforming into the person they have always dreamed of being.

For more information or to ask questions directly about Mommy Makeover surgery, visit my website!  
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