Breast Implant Illness (BII)

Breast Implant Illness (BII)

What is Breast Implant Illness (BII)

Breast Implant Illness has been, and still is a poorly-defined group of symptoms in patients with breast implants. These symptoms vary widely, and many patients have multiple symptoms. Because there is no test that can confirm the diagnosis of Breast Implant Illness, those of us who believe in science as opposed to blog site silliness have to depend on studies of large groups of patients with these symptoms.

First, I want my patients to know that I am personally convinced that the symptoms are real, and related to the presence of breast implants. I am happy to remove breast implants in these patients, and am doing so more frequently as more information on this issue comes to light.

Options for treating BII have been promoted in the lay literature and blog sites, and by some surgeons. Unfortunately, some of these options have not been developed by actual research. One point of particular contention: “En Bloc Removal.”

What is En Bloc Removal (Capsulectomy)?

After breast augmentation, a layer of scar tissue forms surrounding the breast implant. This is an expected, normal part of the healing process. It has been suggested primarily by the non-medical, non-scientific information sites that the treatment of BII should include a total removal of the capsule surrounding the breast implant, and even further, to remove the capsule in a non-interrupted or “En Bloc” fashion. Some propose a partial removal of the capsule, which usually involves removing only the capsule overlying the implant. Patients will sometime see this procedure referred to as a full or partial capsulectomy.

The debate over the necessity of any of these options has led to much debate and the need to take an educated, scientific approach to studying the need to treat the capsules surrounding the implants

What Does Research Say?

A large recent study conducted by the Aesthetic Surgery Education and Research Foundation was dedicated to researching the systemic symptoms self-reported by some breast implant patients. This study was funded entirely by the Foundation and there was no outside sponsor involvement in any aspect of this study. The full study is published in a peer-reviewed medical journal, The Aesthetic Surgery Journal. This is the first prospective study with control groups to evaluate women with Breast Implant Illness with symptom surveys as well as detailed examinations of blood and implant capsules. The goal of the authors was to investigate measurable differences between groups of these patients to help explain symptoms and point to potential causes. Here are the key findings published in this study:

  1. There are women with breast implants who experience a variety of symptoms that they attribute to their implants.
  2. They have real symptoms and are distressed that no diagnosis can be made.
  3. The ASERF study demonstrated that 94% of these patients showed improvement in systemic symptoms after removal of their breast implants.
  4. The symptom improvement is independent of (not related to) the type of capsulectomy performed and there was no statistical difference in symptom improvement whether the entire capsule was removed or partially removed at the time of implant removal.
  5. The study showed low measureable levels of some heavy metals in implant capsules as well as in normal breast tissue that had never been exposed to any implanted medical devices. None of the groups had tissue levels that exceeded The International Conference on Harmonization level of acceptable exposure levels of heavy metals.
  6. There was no significant difference in the presence of bacteria on the implants or in the capsules between the groups validated by analysis by the presence of bacterial DNA.
  7. Blood analysis showed very few statistical differences between the groups.
  8. Further prospective research is necessary to determine which patients might be at risk for developing systemic symptoms after getting breast implants and how best to treat these patients.
  9. A one-year follow-up study will be published in 2023. “The bottom line is that we found that the patient’s symptoms improved after implant removal and they may improve without a capsulectomy”.

So, Do I Need a Capsulectomy?

In short, the research shows two things. 1) Some patients with Breast Implant Illness saw significant symptom improvement after their implants were removed; and 2) The symptom improvement happened whether or not they also removed the tissue surrounding the implants.

I want my patients to understand that some of the information found on various blog sites, etc.. do not appear to be correct. The phrase “en-bloc removal” of implants simply means removing the capsule surrounding the implants, assuming there is something harmful in this tissue. This large study confirms that this is not likely to be true, regardless how fervently it is suggested in the lay literature.

This is important to patients because of the complication rates associated with total capsulectomy which include hematoma (collections of blood) and pneumothorax (collapsed lung). Sustaining a pneumothorax is treated with a chest tube and most often hospitalization. Total capsulectomy involves longer operative time and longer incisions. This scientific study does not find that total capsulectomy improves the rate of improvement of symptoms, nor did partial capsulectomy.

The lack of finding significant levels of heavy metals in the capsular tissue also leads to question whether a total capsulectomy is of benefit to these patients.

The knowledge of Breast Implant Illness is a work in progress. I have removed a lot of breast implants, and there are other considerations to be mentioned. After the breast tissue and skin has been stretched for longer periods of time, removing the implants often leaves a less than satisfactory appearance. Some patients choose to simply remove the implants and not worry about any resulting droopiness and lack of shape. At a later date, they may choose to have a breast-lift performed. Other patients choose to have the breast-lift at the same time as the implant removal. There are pluses and minuses with either approach, and the final decision rests with the patient. These options are discussed in detail at the time of the consultation.

As more information about Breast Implant Illness becomes available, I will include updates in future blogs. If you feel you may have Breast Implant Illness you can call the office to schedule a complimentary consultation.