Textured breast implants and health risks

We at Montecito Plastic Surgery have been occasionally asked about the recent news that textured breast implants have been taken off of the market in many countries overseas.  There have been recent FDA hearings about the safety of breast implants, and (as is often the case) the news cycle has turned it attention to breast implants significantly in recent months.  What’s going on?

Well, first of all, let’s get this off the table so any of you who are nervous can relax… breast implants are generally very safe, particularly if you have had your surgery by Dr. Lowenstein (see below).  If you are not noticing anything concerning about your breast implants, you don’t likely have anything to worry about.  But for education’s sake, let’s discuss the things that you may be hearing about.

Some history….

Back in the early 1960s the breast implant was invented.  They were used in multiple configurations for both reconstruction and aesthetic breast augmentation all over the world.  When some women who had breast implants began to complain about various diseases, the FDA placed a moratorium on silicone filled breast implants in 1992.  Unfortunately for women who wanted these implants, the fact that systemic diseases occur in both women with and without implants were overlooked.  The moratorium was put in place at that time because of “inadequate information to demonstrate that breast implants were safe and effective”. 

Subsequently, several studies were done to investigate any correlations between breast implants and systemic illnesses.  In 1997, the results of the extensive research were delivered by the Institute of Medicine, a subdivision of the National Academy of Sciences who had been appointed by the US Department of Health and Human Services.  The report said that, “evidence suggests diseases or conditions, such as connective tissue diseases, cancer, neurological diseases, or other systemic complaints or conditions are no more common in women with breast implants, than in women without implants.” Further studies at that time were outlined in the FDA Breast Implant Consumer Handbook and agreed with these findings.  In 2006 silicone filled breast implants were returned to the US market and since then these breast implants have been one of the preferred choices for many breast augmentation patients.

In 2011 the FDA first identified a possible association between Anaplastic Large Cell Lymphoma (ALCL) and breast implants.  ALCL is a T-cell lymphoma that that is a type of non-Hodgkin’s lymphoma, which is a cancer of the immune system.  ALCL is NOT breast cancer, and in fact is much easier and more successful to treat than breast cancer.  ALCL is also MUCH MUCH more rare than most other cancers.  The majority of ALCL cases are curable, and the usual sign of ALCL include swelling of the breast which is due to a collection of fluid surrounding the implant.  Other symptoms can include a lump in the breast or armpit, firmness of the breast, or pain.  If a doctor is seen at the first symptom of problem, ALCL is usually easily and completely treatable.  Here again, if you have no problem with your implant, it is unlikely that you need to worry about ALCL at this time.

The risk of getting ALCL seems to be closely related to the type of breast implant surface, rather than the content (saline or silicone) of the implant.  Here is a critical piece of information:  There have been no confirmed cases of ALCL found in patients who have only had smooth surface breast implants (as opposed to textured surface implants), and this is why Dr. Lowenstein only uses smooth surface breast implants unless a textured surface is specifically requested by the patient.  So, if you are one of Dr. Lowenstein’s primary breast augmentation patients, the odds that you will get ALCL are particularly very very very low.

Recent developments

With respect to the increased risks for ALCL in patients with various textured surfaces, several countries around the world have made such implants unavailable to patients.  Most recently (and a trigger of many news stories) the ANSM in France which is like our FDA  announced that, “Out of an abundance of caution the ANSM has withdrawn the sale of macrotextured and polyurethane covered breast implants. ANSM does not recommend preventive explantation for women with these implants.”  In the United States, the FDA has continued to allow the decision regarding textured implants to be left in the hands of the patients and plastic surgeons.  Dr. Lowenstein, being the conservative plastic surgeon that he is, has chosen to limit his use of these implants unless specifically requested by the patient.

In March of 2019, the FDA conducted hearings regarding the safety of breast implants with respect to both the concern for associated diseases as well as ALCL.  Patients who complained of various symptoms that they associate with their implants refer to these symptoms as Breast Implant Illness (BII).  In all of the multiple studies that have been performed, there have remained little to no links between breast implants and any disease other than ALCL as discussed above.  It is important to remember however that these studies do not mean that such patient’s symptoms are not real, and anyone who wishes to have their implants removed because of concerns of any reason has every right to do so.  For patients considering breast implants, however, there are no studies that show there are risks of systemic diseases associated with breast augmentation with smooth surfaced silicone or saline breast implants such as those used by Dr. Lowenstein.   

Recommendations

Patient education is the cornerstone of Dr. Lowenstein’s Montecito Plastic Surgery practice.  If you have concerns about your current breast implants, or if you are considering breast augmentation and have questions about risks and benefits, you should know that these discussions are a part of every breast implant consultation that Dr. Lowenstein has. 

In particular, if you have concerns about having textured breast implants in the past, such as textured round or shaped implants, or you have a concern because your implants are firm, painful, or enlarging, or changing in any way that is not comfortable or aesthetic, it is very reasonable to see Dr. Lowenstein for an evaluation.  In cases of revision surgery from other physicians, Dr. Lowenstein has considerable expertise in managing breasts with these issues.  For patients interested in their first breast augmentation, a consultation with Dr. Lowenstein will leave you feeling that you have all of the information that you need to make a safe, informed choice.