Since its invention in 1961 by plastic surgeons Thomas Cronin and Frank Gerow, breast augmentation has become one of the most frequently performed plastic surgeries in the United States, with 300,378 procedures done in 2017. Although it’s considered an elective procedure, in cases where cancer has robbed a woman of her breasts, surgery can help her regain confidence and feel like her old self again.
In non-post mastectomy cases, there is great debate as to why women choose to have this type of surgery. Some say they chose augmentation to feel more confident in appearance or to correct misshapen breasts due to age or childbearing. Those who oppose augmentation argue one reason women feel they need to have this surgery is to fit into society’s unrealistic expectations of the ideal body type. Although this subject is best left to the sociopsychologists to debate, recently, the U.S. Food and Drug Administration (FDA) has added a new angle by proposing a black box warning on all breast implant devices. For the FDA, the debate centers around safety.
In a document issued on Oct. 24, 2019, the FDA drafted new guidance for breast implant labeling and patient education, suggesting a black box warning on all devices. There are two types of implants, saline and silicone, both of which are the subject of this draft. Saline-filled versions are inflated to the desired size with sterile isotonic saline, and silicone gel-filled breast implants contain a fixed volume of silicone gel. The shell of both types is made from polysiloxane silicone rubber and can vary in surface texture, shape and thickness.
As with all medical devices, breast implants have a lifespan. On average, most last 10-20 years before needing to be replaced. Recent FDA reports indicate that about 20% of women will have their breast implants repaired or replaced within 10 years of the original surgery.
Why a black box warning?
According to the FDA, new information has brought to light several risks associated with breast implants, which have prompted the organization to consider this strict warning label. First on their list is breast implant-associated anaplastic large cell lymphoma (BIA112 ALCL) and, secondly, a group of systemic symptoms commonly referred to as breast implant illness (BII). BIA-ALCL is a type of non-Hodgkin’s lymphoma that, when it occurs, is most often found in the scar tissue and fluid near the implant.
The risk of breast augmentation patients developing BIA-ALCL is low, and treatment has a high success rate if implemented early. These treatments include surgery to remove the implant and surrounding scar tissue, and sometimes chemotherapy and radiation. Symptoms of BIA-ALCL are persistent swelling, and presence of a mass or pain in the area of the breast implant.
The other illness associated with these devices is somewhat of a mystery and includes systemic symptoms such as fatigue, memory loss, rash, “brain fog” and joint pain. Health officials have coined the term “breast implant illness” to describe this phenomenon, and although real for those who suffer, the exact relationship of these symptoms to breast implants is currently unknown. However, some patients report complete resolution of symptoms when the implants are removed without replacement.
Because implants can rupture or leak, the FDA also wants to update current rupture screening recommendations and replace them with more aggressive practices. According to the draft, new guidelines would include MRI screening exams between 5-6 years post-surgery with rescreening every 2-3 years.
Are there alternatives to saline and silicone devices?
Unfortunately, there aren’t that many, aside from prosthetics and other externally worn devices and undergarments. According to breastcancer.org, fat grafting, also called autologous fat transfer, is emerging as a new breast reconstruction technique. In this procedure, fatty tissue is removed from other parts of the body by liposuction, processed into liquid, and injected into the breast area.
The benefits of this new procedure include the fact that it uses the body’s tissue instead of an implant, and the results feel much like natural breasts. However, because it’s a relatively new technique, long-term outcomes and success rates are unknown due to lack of studies.
Although augmentation and reconstruction are primarily elective procedures, in some cases, the benefits for the patient far outweigh the risks, especially in cases where a disease like cancer strikes and removal of the breast is the only choice. Although the social debate on this subject continues, essentially breasts are a body part of varying size and shape that mainly serves one purpose and one purpose alone, and that is to feed infants. That being the case, then shouldn’t those with less than “perfect” breasts also be revered as societies ideal? Because to babies, size and shape most likely don’t matter in the least.
Kimberly Drake can be reached at [email protected]