At the FDA Public Advisory Meeting (March 2019) in Washington D.C., more than sixteen hours of hearings were conducted to evaluate the current state of breast implants and the association with Implant-Associated Lymphoma (BIA-ALCL) and the increasing attention to Breast Implant Illness.
Textured silicone implants have been removed from the market in several European countries. Best practices for the evaluation of patients and the use of implants were reviewed. Women with Breast Implants should be aware of these issues and options of treatment. They should seek out Board Certified Plastic Surgeons, (ABPS) through the American Society of Plastic Surgeons or American Society of Aesthetic Surgeons for a consultation to see if they need any treatment and if so, what are their best alternatives.
Which are the “bad implants”?
There are several categories of implants. Saline and silicone gel are the two large dividers. Saline implants have a silicone shell or bag that is filled with saltwater. The older implants were one bag, like a balloon, filled after being put in place. Currently, we use the Ideal® Structured saline implant. This implant is constructed to feel more natural, somewhat like a silicone implant, without the problems associated with gel implants. Saline implants are rarely associated with any of the problems under review.
The next category is smooth and textured implants. Textured implants were developed for two reasons: the first is to decrease the incidence of firmness or breast encapsulation. The second is to prevent the implants from turning around inside the body. The texturing acts like Velcro. This is important for the next category: Shaped versus Round implants. Shaped implants were designed to have a teardrop or natural shape. They must be textured to keep them in position with the larger, fuller part at the bottom of the breast. Certain types of rough texturing in silicone implants appear to be the cause for most of the BIA-ALCL problems. There is a small group of women who appear to have Breast Implant Illness, BII, from smooth silicone implants and even a smaller number from saline implants. The symptoms for Breast Implant illness vary widely and include problems ranging from difficulty in thinking (brain fog) to fatigue, chest pain, hair loss, headaches, chills, photosensitivity, chronic pain, rash, anxiety, depression, and
collagen vascular disorders such as rheumatoid arthritis. This makes the diagnosis very difficult and women with these symptoms are often unfairly discounted and go untreated.
When should Implants be removed?
Women with ruptured or broken silicone implants or deflated saline implants should have these removed or replaced. Silicone implants older than ten years should be replaced as the incidence of leaking increases towards ten years and rises rapidly after this time. Women with symptoms of BIA-ALCL or Breast Implant Illness should have their implants removed with En-Bloc implant removal.
Women often decide to remove their implants to alleviate discomfort. Firm, hard breast capsules can create pain or they can be aesthetically displeasing. In addition, some women may feel that their breasts are too large as they get older, gain weight, or have changes in their lifestyle and request a “reduction” for these reasons.
I want my implants removed, now what are my choices?
There are several options for removal of the implant and a number of choices moving forward. As noted above En-Bloc Explantation requires a larger incision, usually in the breast fold to remove the entire capsule and implant as one unit. This is performed for Breast Implant Illness or Breast Implant-Associated Larger Cell Lymphoma. A Total Capsulectomy removes the implant and capsule but can be done through a smaller incision, opening the capsule and removing the implant and any loose gel, then removing the entire capsule. This can be done for asymptomatic women who just need the implant removed. An implant exchange can then be performed for women who still want a breast implant. It can be changed to an Ideal® saline implant or another gel implant of their choosing. At this time, we prefer Sientra silicone gel implants as we feel they are very high-quality devices and Sientra will distribute these implants only to board-certified Plastic Surgeons. The implant may be larger or smaller, depending upon the patient’s goals. If there is sagging, a breast lift or mastopexy can be done with or without an implant. Another great option for women is the use of fat transfer. The “Natural Breast Augmentation” or breast lift with augmentation uses the patient’s own fat to add volume where needed and to help enlarge and shape the breast. Fat can be used alone or in combination with an implant, Hybrid Breast Augmentation, to obtain the best size and contour for the patient.
The wide selection of options and the complexity of these choices is best discussed with your Board Certified Plastic Surgeon. Always check on credentials and experience for your safety and best outcome.
Jed Horowitz MD FACS 5/31/19