This page was last updated March 2019. Dr. Teitelbaum’s answers to these frequently asked questions are practical and based upon his experiences speaking to patients about this topic and his understanding about what other plastic surgeons are discussing. More thorough regularly updated information can be found at these sites, and Dr. Teitelbaum suggests you also look through them:
Though this is called a “recall,” they are not actually being recalled; they are just stopping sales and are offering a free pair of replacement implants to patients with textured implants.. No plastic surgery society, manufacturer, or government regulatory agency recommends removal of these implants. Read through the questions below for answers to the questions you probably have about what to do if you have these implants.Read Full Article from PR News Wire Here FDA Announcement of Cessation of Allergan Textured Implant Sales Read New York Times Article Here AGN offers replacement implants
It is a rare type of lymphoma that has been found around breast implants. It is not a cancer of the breast tissue. It starts as a collection of fluid around the implant that contains abnormal white blood cells. This results in breast enlargement. If caught at that stage treatment just requires removal of the implant and the capsule surrounding it. But if left untreated it can spread outside of the capsule and become very serious.
The most common symptom is a collection of fluid surrounding a breast implant, resulting in swelling of one breast 2 to 28 years after the insertion of the breast implant. Uncommonly it can present as a lump in the breast or armpit, an overlying skin rash, or hardening of the breast.
As of July 2019, there have been 573 cases and 33 deaths reported worldwide. 481 of the cases have been clearly attributed to Allergan implants. Of the deaths, the type of implant was known in only 13 cases and in 12 of those it was an Allergan implant. Many or most of those deaths occurred because of a delay in diagnosis, delay in treatment, or mismanagement.
In 85% of cases it is essentially a clinically benign process. There is a build-up of fluid, the breast enlarges, and after removing the implant and scar tissue there is no further problem. But for about 15% a more extensive surgery and even chemotherapy or radiation is necessary. It seems that many of the 15% had earlier symptoms but the diagnosis was delayed.
As of July 2019 there have been 33 deaths reported worldwide. Most of those deaths occurred in the past before doctors knew what it was or the patient was improperly treated. There was also usually a delay in diagnosis, such as a patient not seeing their doctor after they developed breast swelling or the doctor not running the proper tests on the swollen breast to make the diagnosis. We expect that with patient vigilance about swelling and surgeon awareness that the death rate should approach zero.
It has been reported with other implants, including gluteal implants, and even sutures in orthopedic surgery.
So far it has only been seen in implants with a textured surface. There have been no cases resulting from smooth implants, though there are cases in which it has been found in patients with smooth implants, but they had received a textured implant at some point before that.
Textured breast implants have a number of advantages. All teardrop implants are textured, so if you have a teardrop implant your implant must be textured. Until very recently the very most cohesive/gummy bear-filled implants were teardrop, and so if you have that filler you would have to have a textured implant. There is evidence that texturing reduces capsular contracture and movement of the implant out of its ideal position. For decades textured implants were the most commonly used implants around the world. So there are many good reasons a patient may have those implants.
The risk is related to the increase of surface area by the particular type of texturing. The risk is greatest with Biocell™ texturing, which is currently made by Allergan, but originally by McGhan and later by Inamed. (This is the texturing that is used on the Style 410 anatomic/teardrop implant.) Cases have been reported with Silimed/Sientra and Mentor textured implants, but less frequently. In November of 2018 Biocell™ implants were removed from the market by European regulatory bodies, but to date the FDA has believed their benefits are substantial enough that they should be left as a choice for patients and surgeons.
By March 2019 many countries worldwide took them off the market. In May 2019 the FDA reviewed and decided to keep them on the market given that they are advantageous in certain situations. But in July 2019, following the report of more deaths internationally, the FDA asked Allergan to voluntarily stop sales of all of its textured implants. But textured implants by Sientra and Mentor remained on the US market. Even though the language has been that this is a “recall,” it literally is just a removal of products from the market, not a suggestion to have them removed.
The risk for Biocell™ (Allergan’s texturing) may be as high as 1:2000. The rate is much lower with Silimed/Sientra and Mentor. Mentor’s is said to be abut 1:86,000.
The range has been from one to twenty-seven years, with a mean of about 8 years.
The risk is the same for silicone and saline. The problem is related only to the surface of the implant.
The answer to this has not been completely proven, but the data is convincing that texturing matters because it increases the surface area around the implant. That gives bacteria a place to accumulate and those bacteria result in long term inflammation of the surrounding tissues. The inflammation attracts white blood cells, and as they continue to reproduce some of the cells can become malignant.
There have been fewer than ten cases in which patients with smooth surface implants develop anaplastic large-cell lymphoma who had a textured implant in the past. This is probably related to the tissue surrounding the textured implant becoming abnormal before the textured implant was removed. However, if the capsule was removed along with the textured implant this is not a risk. But just as no one has recommended prophylactic removal for patients with textured implants, there is obviously far less of a reason to remove a smooth implant in someone who once had a textured implant. The point is that people with smooth implants still need to be seen if there are changes to their breasts.
The first symptom is usually a significant enlargement of one breast; it is not subtle. When diagnosed at that stage it is entirely curable. But be alert for any change in your breast such as a lump or hardening.
There is no screening test for ALCL. It cannot be diagnosed until a patient develops a symptom. Again, if a patient sees their doctor with the first symptoms it is expected that it will be completely treated.
No. It is only for the evaluation of breast tissue itself. You should always maintain your standard breast health surveillance.
An ultrasound would reveal fluid or a mass, but you wouldn’t get an ultrasound unless you had a mass or an enlargement, or needed it to evaluate a suspicious mammogram.
As of March 2019 there are three cases of trans patients with anaplastic large-cell lymphoma in Europe, but so far none in the United States.
To date there has only been one case in an Asian patient, in Thailand. There is not yet a known case of an Asian-American with it, and textured implants have been the most commonly used implants throughout Asia. There is clearly a genetic component but it is not well-understood.
Neither the FDA nor any plastic surgery society recommends it because the risk is low and there is almost always an obvious early symptom. If the process is caught then it is completely and easily curable. However some patients are nonetheless worried and want their implants removed, and this is reasonable. Usually these patients have already been thinking about a revision for a variety of reasons, such as wanting to change the size, wanting to be softer, etc. Concern about ALCL seems to sometimes push these patients into making the decision to do a surgery they were already considering. At other times the patient comes into the office to discuss ALCL and the doctor points out a problem the patient was unaware of, such as droopiness or hardening.
If a patient is otherwise happy with their result it is very uncommon for people to ask to have them removed; but just because that is what other people do does not necessarily make it the right decision for you. But after hearing about ALCL there are more than a few people getting revisions. Some do so because they were already thinking about it for other reasons and ALCL was enough to tip the scales in their decision-making process. Others came in for follow-up and the doctor noticed something that could be improved but the patient hadn’t noticed.
Allergan has announced that it will offer a free pair of smooth implants to any patient with their textured implants, if the surgery is done between July 24, 2019 and July 24, 2021. This applies to all type of biocell implants, including teardrop, round, silicone and saline, no matter how long ago they were placed. It includes only the cost of the implants and not surgery fees. Since the implants were only removed from the market and since neither the FDA nor any plastic surgery organization has suggested prophylactic removal, they are not paying for surgery and anesthesia and operating room fees.
If there is not ALCL and the patient is just doing it preventatively, the implant can just be removed. The patient can change to a smooth implant or choose to have no implant at all. There have been fewer than ten cases worldwide in which patients with smooth surface implants develop ALCL who have had a textured implant in the past. This is probably related to the tissue surrounding the textured implant becoming abnormal before the textured implant was removed. However, if the capsule was removed along with the textured implant this is not a risk. So the question in these situations is whether or not to remove the scar tissue. It is indeed easy to remove the scar tissue, but it is a somewhat bigger surgery. . If a patient decides to remove their implants purely for fear of ALCL and wants to make the risk absolutely zero, then it would make sense to remove the capsule, but only after a thorough discussion with the surgeon.
In the most common situation one breast significant enlarges and fluid is removed under ultrasound guidance. The fluid is sent for analysis and that is how it is diagnosed.
It usually does, but implant manufacturers cover it under their warranty. So no matter what your situation is with insurance, see a plastic surgeon immediately and they’ll figure out the payment for the work-up.
If the disease is limited to the fluid around the implant (the most common situation) and/or involving the capsule, the treatment is a complete capsulectomy (removal of all of the capsule surrounding the implant) and nothing else. If the disease has spread, chemotherapy or radiation may be necessary. The key is early diagnosis so that it can be treated in that stage. A capsulectomy is one of the most common operations plastic surgeons do, usually for capsular contracture, which is a build-up of scar tissue.
Unless the patient needs radiation or chemotherapy implants can be placed after removal of the scar tissue.