“Breast Implant Illness”

Our practice receives many inquiries from patients (most of whom have had their prior breast surgeries elsewhere) regarding the possibility that they may be experiencing various un-explained symptoms or illness which they believe may be related to the presence of silicone gel breast implants.  While at the present time, there is no clear-cut scientific evidence of a linkage between the presence of implants and any specific disease or symptom complex, there is some anecdotal evidence to support the decision on the part of some women to proceed with implant removal in an effort to eliminate silicone gel as a possible cause.  I now have several patients who have made the decision to remove their implants, often but not exclusively due to other localized problems with the implants (mal-position, pain, capsular contracture, etc.), who subsequently reported improvement in their symptoms.  There are some parallels to the silicone gel “moratorium” where the usage of silicone gel implants was severely restricted between 1992-2007 due to many of the same questions and concerns on the part of patients.  Although the FDA in 2007 cleared silicone breast implants to be re-introduced to the marketplace, and although advances in the design and manufacturing of the implants has steadily improved the reliability of the devices, obviously some questions persist on the part of patients, and it is our obligation to take these concerns seriously.

Under these circumstances, when a patient makes the decision to remove her implants, we counsel them carefully regarding their options, which in many cases may involve re-shaping the breast through a mastopexy (lift) and/or fat transfer to the breast to restore some of the lost volume.

Whenever the implant is to be removed, we endeavor to remove the entire implant within the entire “capsule” around the implant, thereby avoiding any possible spillage of silicone if the implant is ruptured or leaking.  This is often referred to as an “En Bloc” resection.  Sometimes, due to the desire to avoid excessive scarring of the breast (e.g. if no lift is planned concurrently), or due to dense attachments of the capsule to the ribs and intercostal muscles, complete removal of the capsule and implant “en-bloc” is not feasible, and then the implant is removed separately from as much of the capsule as can be safely removed (“capsulectomy with explant”).

We will be happy to meet with you to discuss your options should you choose implant removal.

BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma)

The following is a message I posted on my practice’s Facebook site last month, regarding BIA-ALCL associated with the recall of Allergan textured breast implants and tissue expanders.

To my many patients and friends:

During the past week, there have been many reports in the news media regarding a rare form of cancer which appears to be related to textured silicone gel breast implants. Specifically, Anaplastic Large-Cell Lymphoma (ALCL) occurs in the cells lining the pocket that forms around textured-surface implants, rather than being a sub-type of cancer of the breast itself. The disease is therefore called “Breast Implant-Associated Anaplastic Large Cell Lymphoma”, or BIA-ALCL. Although extremely rare (573 cases and 33 deaths worldwide, according to recent FDA data), most of the cases have been associated with Allergan Biocell textured implants. On July 24, Allergan issued a voluntary recall of all Biocell implants and tissue expanders.

Many patients have contacted me regarding the type of breast implant they received during either augmentation or reconstruction. The majority of Biocell textured implants I have placed in my practice have been for breast reconstruction, or as part of the Allergan Style 410 (silicone) or 468 (saline) pre-market approval clinical studies, for which I was a clinical investigator.

Although this implant-related condition undoubtedly and understandably raises a great deal of anxiety among breast implant recipients and their loved ones, rest assured that I remain committed to your health and safety. Currently, due to the very low incidence of the disease and the specific relationship to the Allergan Biocell textured devices, the FDA does not recommend implant removal for patients without symptoms, even those who have Allergan Biocell implants. Specifically, symptoms such as unusual swelling of the breast may indicate the need for further evaluation and testing of any fluid found in the space around the implant. Nevertheless, Allergan has today announced an extension of their implant warranty to cover any patient desiring replacement of any Biocell implant product with a comparable smooth saline or silicone implant at no charge (other surgical costs are not covered).

As my patients all know, regardless of the procedure, I endeavor to remain involved in your care on a life-long basis; I specifically ask my breast patients to return as-needed or annually to maintain follow-up of your breasts.

If you have questions or concerns regarding your breasts, please do not hesitate to contact our office to arrange a visit at your earliest convenience.

Warmly,

Dr. C