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From the American Society of Plastic Surgeons : Frequently asked questions about BIA-ALCL.

Wednesday, September 25th, 2019

1. Do I need to have my implants removed?

No, the FDA has specifically stated that implant removal is not necessary at this point unless you are diagnosed with BIA-ALCL. Having symptoms such as breast swelling, a lump in your breast or armpit, persistent breast pain, a rash or any change in your implants should be investigated by your physician. If you have any of these symptoms you should make an appointment to see your board-certified plastic surgeon and member of the American Society of Plastic Surgeons.

2. I have Allergan BIOCELL implants. What should I do?

Unless you are having the symptoms noted below, there is nothing to do at the present time other than routine continual breast examinations. Any changes in your breast should be examined and discussed with a board-certified plastic surgeon. The current recommendation from the FDA is that women with Allergan BIOCELL implants that do not have symptoms do not require removal. If you have Allergan BIOCELL implants, you should understand that textured surface implants are associated with a low but real risk of BIA-ALCL, a cancer of the lymphatic system. You should know the signs and symptoms of the disease. As long as you have your breast implant(s), you should monitor your breast area for any changes.

It is important to note that on September 12, 2019 the FDA released an update identifying Allergan BIOCELL Textured Breast Implant(s) as a Class I recall, the most serious type of recall. If changes to your breast(s) arise, you should seek evaluation promptly. More information about BIA-ALCL can be found at:

3. I have a textured implant(s) but my implant(s) have not been recalled. What is my risk for developing BIA-ALCL?

At the present time, your exact risk is not known. However, it appears to be significantly less than the risk noted below in question 4. The FDA and a 2017 study of US epidemiology of BIA-ALCL noted that Allergan BIOCELL implants appeared to be 6x more likely to be associated with the development of BIA-ALCL than other textured implants currently on the market.

4. What is my risk of BIA-ALCL? Is my risk of BIA-ALCL lower if I remove my implants and do not have them replaced?

The risk and incidence of BIA-ALCL in patients with Allergan BIOCELL textured implants ranges from 1:443 (median of 7 years) to 1:3345. The overall risk of BIA-ALCL in the US is 1:30,000 which is an average of several high and lower risk textured implants. There is no known procedure that can reduce risk for the development of the disease in the future. Patients have developed BIA-ALCL with a history of a retained scar capsule and a history of only simple implant exchange. However, patients should note that the current risks associated with any surgery are higher than the risk of developing BIA-ALCL. Discuss all benefits and risks with your board-certified plastic surgeon. Understanding all potential risk factors will help with better decision-making that is best for you and your health.

5. I had (or currently have) textured tissue expanders. Should I be worried? What is my risk of BIA-ALCL?

Risk of disease with tissue expanders has not been determined at this time. It is important to stay vigilant and upon noticing any changes in your breasts, consult a board-certified plastic surgeon.

6. Is there a screening test for BIA-ALCL?

At present there is no screening test or tool for BIA-ALCL. The best course of action is careful routine breast examination. If you have symptoms such as breast swelling, a mass in your breast or armpit, a new rash on your breast or persistent breast pain, or any change whatsoever in your breasts, you should see your plastic surgeon for evaluation.

7. I have symptoms of BIA-ALCL. What should I do?

The most common sign of BIA-ALCL is fluid or swelling around a breast implant. This usually happens many years after the implant was originally placed. BIA-ALCL can also cause tumors that arise from the scar capsule around the implant. Less commonly, BIA-ALCL can cause a breast to become lumpy or misshapen with the development of thick scar capsule around an implant.

If you have any of these symptoms of BIA-ALCL or other changes in your breast(s), your health care provider should evaluate you promptly. It is important to note that these signs and symptoms do not necessarily mean a diagnosis of BIA-ALCL. These changes, for example, can also result from a leaking implant or trauma to the breast area. To evaluate for BIA-ALCL, your health care provider will take your history, perform a physical exam and may order imaging or an assessment of any fluid or tissue around your implant.

8. If I choose to have my implants removed and/or replaced, do I need to have the capsule (scar around my implant) removed? What is an En-Bloc resection?

If you choose to have your breast implant(s) removed out of concern for BIA-ALCL, you should have a discussion with your surgeon about implant removal, implant exchange, and partial or total scar capsule removal. The surgical removal of the scar capsule around your implant is called a “capsulectomy” in an otherwise healthy patient. Having a total capsulectomy at the time of implant removal is not known to change the risk of developing BIA-ALCL. The risk of performing a capsulectomy includes, but is not limited to, bleeding and other wound complications. For reconstruction patients, a capsulectomy could result in a change of shape to your breast or loss of the reconstruction.

En-Bloc resection is often a misused term that means a cancer removal in a BIA-ALCL diagnosed patient with removal of the implant, complete capsule in conjunction with any associated mass and a rim or margin of surrounding healthy tissue.

9. I didn’t receive an implant card. How do I find out what kind of implant I have?

The best and easiest way is to contact the surgeon who performed your surgery or the hospital where you had your surgery performed and ask for your medical records. If your surgeon is no longer in practice or a significant time has elapsed since your surgery, the implant manufacturers may have this information through their device tracking mechanisms. Call the medical information division at one of the companies to find out about your implants.

10. Am I in the NBIR/PROFILE registries?

The aggregate NBIR and PROFILE registry datasets do not contain any personal identifying information. Contact your plastic surgeon and/or treating physician to determine whether or not your information was entered in either registry.

The Dangers of Plastic Surgery Tourism

Thursday, July 24th, 2014

PIP Breast Implants in the United States

Friday, January 13th, 2012

There has been a lot of news recently about PIP implants   and concerns that not only do they rupture at a rate higher than other implants but the silicone inside may not be medical quality.  Fortunately these implants  were never sold in the United States.  PIP did sell prefilled saline implants in the United States for a while (apparently about 35,000 were sold). However when  the FDA asked the three implant companies ( Inamed -now Allergan, Mentor , and PIP) in 2000 to submit a formal application (known as pre-market approval) only two of the companies received approval.  The two companies that received approval -  Inamed (Allergan) and Mentor-  are still the only two companies selling silicone implants in the United States.  PIP has stopped selling its prefilled saline implants in the U.S.A.

Timing of Surgery

Friday, January 13th, 2012

There were several reports over the holidays about the numbers of cosmetic surgeries and even reconstructive surgeries going up.  Is this just a typical cycle or is this an indication that the economy is improving?   It is true that all hospital admissions went down during the past few years -  a direct result of the recession.    When you are worried about the stability of the job market you are unlikely to take time off from work for an elective procedure or want to dig deep to pay those deductibles.    There for it is a good sign that elective procedures were up in December.  There is also the timing factor though.  Although there is no “convenient’ time to schedule an elective procedure -  there are less inconvenient times.    Timing a surgical procedure around a holiday can allow you to “steal” some more time off work.  A lot of offices are closed between Christmas and New Years which can allow you to to recover without sick days.  There are other times during the year when you can “steal “  extra time off –  long weekends such as Memorial Day, Labor Day or even the 4th of July are examples.   Often people expect offices to be closed or  at least not fully staffed so your absence is not questioned.  Plan ahead though as lots of other patients might have the same idea!

Visitng Educator in Ecuador

Friday, December 16th, 2011
I just returned from a trip to Porto Viejo Ecuador.  This was a Visiting Educator ( VE ) trip sponsored by Resurge( Interplast).   The purpose of this trip was to work alongside residents in Plastic Surgery from the University of Guayaquil and to help teach them techniques in cleft  lip and palate repairs.  Visiting educator programs also exist in the united States.  Professors from one university travel to others and lecture as well as sometimes operate alongside the residents to expose the residents to different techniques and skills.  It is a privilege to be invited to participate in such a program.  I was very impressed with the caliber of the residents and I must admit the exposure to different types of cases and the compexities of the cases they see is beyond what most residents in the United States see in their training.  As alwyas I get so much more from these trips than I give.  I am lucky to be able to participate in programs such as these.

Numbers of Plastic Surgery procedures increases as Economy improves

Thursday, February 10th, 2011

The American Society of Plastic Surgeons released their statistics for 2010 yesterday.  The overall number of cosmetic procedures increased 5 % in 2010.  This may represent some pent-up demand as patients return who had put off cosmetic work when the economy was so unstable.  Reconstructive procedures also increased 2% in 2010 with breast reconstruction up 8% !  This puts breast reconstruction into the top five reconstructive procedures for the first time .  The other top reconstructive procedures were (1) tumor removal (2)laceration repair (3)scar revision and (4) hand surgery.  Good news !  Hopefully this means that our work to get the word out to patients  undergoing mastectomies about their reconstructive options is working!

My Christmas Present

Friday, December 17th, 2010

Dr Jorge Palacios just gave me the most wonderful Christmas present.  I was with Dr Palacios in Ecuador on a visiting educator trip where we were training young surgeons to do cleft lip and palate surgery.  One of the patients was a 45 year old woman with an unrepaired cleft lip.  Dr Palacios assigned her care to me.  in 45 minutes I was able to repair her lip-  a 45 minute operation for which she had waited 45 years !!  I am so grateful that I was able to do this for her.   She will be able to smile at her children and her husband for the first time .  To be given a chance to help another person like this is priceless.

Plastic surgery in Ecuador

Friday, December 17th, 2010

I just got back from spending ten days in Ecuador.  I was a visiting Educator with Resurge( formerly known as Interplast).   This was my fifth trip to Ecuador and my third as a visiting educator.  Most medical missions that I have been on   we are just trying to get as much surgery done as well and safely as we can in our limited time. A visiting educator trip is different -  on these trips we are trying to teach local doctors to improve their techniques and help improve through our training the outcomes of many surgeries after we leave.  It is exactly like the old adage -  give a man a fish and your feed him for a day,   teach a man to fish and you feed him for a lifetime!    I always get so much more out of these trips than I give -  we are so lucky in this country with all that we have .   I am very gratefull that I have the opportunity to give back in even a small way.

Aging and what we can do about it

Thursday, April 23rd, 2009

A most interesting article was in last months Plastic and Reconstructive Surgery journal.  I don’t ever remember having taken an article to show my staff but this time  I did.  The article described observations at the annual identical twin conference.,  Twins were photographed and then asked questions about their lifestyle choices.   The twins were then rated as to whom and appeared older -  remember these  were identical twins -  and then the twins that looked older were evaluated.  The results were amazing -  identical twins who looked 10 -20 years older than their twin!!!!  I tell you -  look at these pictures and not only will you never smoke you will never go outside without sunscreen !!!  However a little good news for us -  a few extra pounds helped the twins looked younger -  YES!   OK the bottom line -  sunscreen, don’t smoke and don’t get too skinny!

Plastic surgery and the recession

Tuesday, March 31st, 2009

The media has been all over the recent statistics released from the American Society of Plastic Surgeons showing the number of cosmetic surgical  procedures done in 2008 to be down 9%.  However as always when one looks closely at the statistics this is not the whole story.  Overall cosmetic procedures ( not just surgical procedures) are up 3%! This includes Botox and fillers such as Restylene , Juvederm and Evolence. And Reconstructive procedures are up 3% as well.  Not bad for the worst recession since the great depression! I was very pleased to see that breast reconstruction was reported up by 39% -  this means to me that women are getting offered breast reconstruction and as they should ( there is a Federal law mandating that insurance companies cover reconstruction after cancer treatment) insurance companies are covering the procedures.  There was also an increase in lower body lifts and buttock lifts both of which are procedures often done after patients have lost a lot of weight -  both by diet as well as by bariatric surgery.  The news is not always that bad it matters what you are looking for!