Breast Implants

Etiology

The breast implant controversy peaked in the early 1990s when Connie Chung aired a segment suggesting implants were causing autoimmune diseases after anecdotal reports were linking gel implants with systemic diseases such as connective tissue disorders and even cancer. Due to safety concerns and lack of clinical studies to support the safety of the devices, the FDA issued a moratorium on the use of gel implants. This led to a class-action lawsuit that was settled in 1994 and led to the chapter 11 bankruptcy of Dow Corning. Saline implants were the only type that was available until the return of gel implants in the mid-2000s.[5][6][7][8]

Epidemiology

In 2000, the Institute of Medicine published its summary findings of all the research done on implants. They concluded that there was no evidence that silicone implants caused any systemic diseases and that implants do not last forever. Despite many attempts to refute this, no new evidence to the contrary has been found. In March of 2017, the FDA did issue a warning that there was a link between textured implants and anaplastic large cell lymphoma. This is now called breast implant-associated anaplastic large cell lymphoma or BIA-ALCL, and the risk of having this occur was estimated to be 1:30,000.[9]

Toxicokinetics

To the best of our knowledge, and since publication from the Institute of Medicine in 2000, there is no evidence to suggest any relationship between silicone and systemic diseases of the whole body. Despite continued research, there is no new evidence to suggest otherwise. It is also important to understand that implants do not last forever and that having an augmentation will require more surgery in the future to maintain results or to deal with complications such as contracture or malposition of the implant. More recently, women have been claiming breast implant illness (BII), motivating them to have "en block" removals. Still, there remains no evidence that there is an identifiable link between implants and BII, except for these anecdotal reports.[10]

History and Physical

Implants must be placed in a sterile environment. Implants should be bathed in an antibiotic solution before completely exposing the implant from its packaging to minimize risks for the static attraction of foreign particulates before insertion. Saline implants should only be filled using closed systems where the saline is never exposed to the air to eliminate risks for contamination of the saline. This is accomplished using intravenous (IV) tubing from the source bag to the syringe to the fill tube.

If concerned about implant integrity, implant displacement exercises can usually determine if an implant is intact or not.  With both hands on the augmented breast, the pressure is placed on one hand to move the implant toward the other hand. With intact implants, the implant will displace the other hand, confirming that the implant is intact. With gel implants, if the breasts feel completely normal without any appreciation of the implant, the implant may be compromised. With saline implants, a rupture should be obvious with a smaller, more natural breast mound and no implant appreciated on the exam.

With silicone breast implants, this capsule can camouflage a breast implant rupture, as the silicone will remain trapped within the capsule and show no signs of change. This is called a silent rupture and the reason why the government recommends getting an MRI every two years to evaluate the integrity of the implant. This s not a mandate, and most patients do not follow this unless concerns or issues arise as it is often not covered.

Sometimes the fibrous tissue (capsule) becomes inflamed, resulting in pain, soreness, or swelling.  It can also cause changes in breast or shape, lumps in the affected breast, and hardening of the affected breast.

Evaluation

Ultrasound, mammogram, and MRI may be necessary for evaluating rupture concerns as well as implant displacement mentioned prior to physical exam for gel implants. Saline implant failure is obvious as one mound will become noticeably smaller. If in doubt, have the patient use a molded cup bra that does not stretch and examine her mounds weekly or monthly in the molded cup bra. If there is a leak of any kind, space in the cup will increase as the implant volume diminished from a failing saline implant.

Treatment / Management

Surgical intervention with a replacement of the ruptured implant is recommended if rupture is suspected or documented on radiographic studies or clinical exam, and the patient wishes to maintain her breast volume. If she does not, explant alone may be considered, and in some cases, mastopexy may be needed to produce the best outcome possible.  Deflated saline shells may be left in the breast as long as not problematic or symptomatic, and consideration must be given to repairing muscle origins of the pectoralis major if a submuscular placement was originally done in attempts to minimize or resolve the animation that resulted from submuscular placement.[11][12][13]

Differential Diagnosis

• Breast cancer

• Capsular contracture

• Cysts

• Fat necrosis

• Fibroadenoma

• Fibrocystic disease

• Late hematoma

• Late inflammatory/infectious process

• Papilloma

• Presence of seroma