Silicone breast implant rupture: a review

Abstract

Silicone breast implants have been in use for nearly 6 decades. In this time they have undergone significant changes in design and use. They have been subject to intense scrutiny with regard to safety and efficacy, including an almost 10 years moratorium on their use. The current generations of implants have been followed via the manufacturer's Core studies in order to obtain long term data regarding safety and complications. The results of the more recent studies are compiled in this review. Rupture rates are initially very low and begin to increase after 6-8 years of implantation. Implant rupture may be detected by physical exam, ultrasound or magnetic resonance imaging (MRI). The majority of silicone implant ruptures are clinically undetectable. Symptomatic patients may present with capsular contracture, breast lumps or changes in breast shape. The most common cause of implant rupture is instrument damage during placement. Implant rupture may be confined to the peri-prosthetic capsule or may extravasate into the breast tissue. Patients with ruptured implants have been studied closely and the consensus of the literature states there are no health risks associated with implant rupture. Symptomatic patients with ruptured implants should be offered the choice of observation, or explantation and capsulectomy with or without replacement.

Breast augmentation surgery: Clinical considerations

“…The fi rst silicone gel implants, introduced in the early 1960s, [8][9][10][11][12][13][14][15][16][17][18][19] had high complication rates-some centers reported an incidence of capsular contracture of up to 70%. 8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful. 11 Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells.…”

“…8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful. 11 Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells. 12 Infl atable implants fi lled with sterile saline solution were originally developed in France in 1965.…”

“…7 Table 1 summarizes the evolution of silicone breast implants over the last 50 years. 2,6,11,12 Table 2 lists the advantages and disadvantages of silicone and saline breast implants. 2,6,8,15 ■ CURRENT IMPLANT OPTIONS Currently, 3 companies (Allergan, Mentor, Sientra) manufacture and distribute breast implants and implant-associated products…”

“…In the United States, implant rupture rates range from 1.1% to 17.7% at 6 to 10 years after primary augmentation, 2.9% to 14.7% after revision augmentation, 1.5% to 35.4% after primary breast reconstruction, and 0% to 19.6% after revision reconstruction. 11 Unfortunately, the existence of multiple implant manufacturers, numerous implant generations, and poorly standardized screening protocols and reporting systems make the true rate of implant rupture diffi cult to assess without defi nitive imaging or implant retrieval. 11 Damage from surgical instrumentation during implantation is the most common cause of silicone breast implant rupture (50% to 64% of cases).…”

“…11 Unfortunately, the existence of multiple implant manufacturers, numerous implant generations, and poorly standardized screening protocols and reporting systems make the true rate of implant rupture diffi cult to assess without defi nitive imaging or implant retrieval. 11 Damage from surgical instrumentation during implantation is the most common cause of silicone breast implant rupture (50% to 64% of cases). 22 Other causes include underfi lling and fold fl aw from capsular contracture.…”