Breast Plastic Surgery - Breast Implant Complications

Local complications that can occur with breast implants include post-operative bleeding (hematoma), fluid collections (seroma), surgical site infection, breast pain, alterations in nipple sensation, interference with breast feeding, visible wrinkling, asymmetric appearance, wound dehiscence (with potential implant exposure), thinning of the breast tissue, and synmastia (disruption of the natural plane between breasts).

Breast Implant Rupture

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.

Manufacturers are required to inform women that the implants are not necessarily permanent devices and that most recipients will likely need additional surgery to replace or remove their implants. Rupture is one reason for reoperation. Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.

Many older studies relied on clinical exams to determine implant rupture rates, while more recent reports indicate that clinical exams alone are inadequate to evaluate suspected rupture. An often cited study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRI.  The FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter. Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.

In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study.  However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. MRI data from the US-FDA required "core" studies of contemporary implants has demonstrated low rupture rates.

The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of at between 8% to 15% at or around a decade. This represented a 15-30% silent rupture risk for individual patients. The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less, at a median age of six years.

When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area). The specific risk and treatment of extracapsular silicone gel is still controversial. Plastic surgeons agree that it is difficult to remove, but there is disagreement about the health effects.

Breast Implant Capsular Contracture

Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma. Capsular contracture may happen again after this additional surgery.

Methods which have reduced capsular contracture include submuscular implant placement, using textured or polyurethane-coated implants, limiting handling of the implants and skin contact prior to insertion and irrigation with triple-antibiotic solutions.

Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound, treatment with leukotriene pathway inhibitors (Accolate, Singulair),and pulsed electromagnetic field therapy.

Breast Implant Scarring

All surgical procedures on the breast leave scars. Scar quality is determined by factors including a patient's ethnicity, tissue quality, wound tension, suture material, tissue trauma from surgery, smoking, and an individuals propensity for favorable wound healing. While most breast augmentation incisions heal well, a rate of 6-7% of unfavorable scarring was reported for primary augmentation patients in US-FDA clinical trials.

Chronic pain and changes in nipple and breast sensitivity
Feeling in the nipple and breast can change after implant surgery. Changes include intense sensitivity, chronic breast pain, and no feeling in the nipple or breast for months or years after surgery.

In their booklets for patients, Allergan and Mentor report that within the first three years, between 2-8% of augmentation patients report moderate to severe chronic breast pain, an additional 1-2% report moderate to severe breast sensitivity changes, and 3-10% report moderate to severe nipple complications such as loss of sensation. These are similar for silicone gel or saline breast implants, but the longer-term data on saline implants indicates that chronic breast pain is reported by 17% of women within five years.

This altered sensitivity can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

Breast Implant - Implant Extrusion and Tissue Necrosis

Compromise of blood supply as a result of surgical procedures may lead to skin loss or breast tissue necrosis (death). Unstable or weakened tissue covering may result in subsequent extrusion of the breast implant through the skin. Implant extrusion and tissue necrosis are rare in breast augmentation patients, but may occur in up to 1-2% of reconstruction patients using implants.Surgery needed to correct this can result in unacceptable scarring or breast tissue loss. Procedures which combine simultaneous breast augmentation with mastopexy (breast lift) techniques carry higher rates of implant loss or wound breakdown than either procedure alone.