Breast Implant Controversy - Complications - Implant Rupture

Implant Rupture

Because a breast implant is a Class III medical device of limited product-life, the principal rupture-rate factors are its age and design; nonetheless, a breast implant device can retain its mechanical integrity for decades in a woman’s body. When a saline breast implant ruptures, leaks, and empties, it quickly deflates, and thus can be readily explanted (surgically removed). The follow-up report, Natrelle Saline-filled Breast Implants: a Prospective 10-year Study (2009) indicated rupture-deflation rates of 3–5 per cent at 3-years post-implantation, and 7–10 per cent rupture-deflation rates at 10-years post-implantation. When a silicone breast implant ruptures it usually does not deflate, yet the filler gel does leak from it, which can migrate to the implant pocket; therefore, an intracapsular rupture (in-capsule leak) can become an extracapsular rupture (out-of-capsule leak), and each occurrence is resolved by explantation. Although the leaked silicone filler-gel can migrate from the chest tissues to elsewhere in the woman’s body, most clinical complications are limited to the breast and armpit areas, usually manifested as granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area).

The suspected mechanisms of breast-implant rupture are:

  • damage during implantation
  • damage during (other) surgical procedures
  • chemical degradation of the breast implant shell
  • trauma (blunt trauma, penetrating trauma, blast trauma)
  • mechanical pressure of traditional mammographic breast examination

From the long-term MRI data for single-lumen breast implants, the European literature about Second generation silicone-gel breast implants (1970s design), reported silent device-rupture rates of 8–15 per cent at 10-years post-implantation (15–30% of the patients). In 2009, a branch study of the U.S. FDA’s core clinical trials for primary breast augmentation surgery patients, reported low device-rupture rates of 1.1 per cent at 6-years post-implantation. The first series of MRI evaluations of the silicone breast implants with thick filler-gel reported a device-rupture rate of 1.0 per cent, or less, at the median 6-year device-age. Statistically, the manual examination (palpation) of the woman is inadequate for accurately evaluating if a breast implant has ruptured. The study, The Diagnosis of Silicone Breast-implant Rupture: Clinical Findings Compared with Findings at Magnetic Resonance Imaging (2005), reported that, in asymptomatic patients, only 30 per cent of the of ruptured breast implants is accurately palpated and detected by an experienced plastic surgeon, whereas MRI examinations accurately detected 86 per cent of breast-implant ruptures. Thus, the U.S. FDA recommended scheduled MRI examinations, as silent-rupture screenings, beginning at the 3-year-mark post-implantation, and then every two years, thereafter. Nonetheless, beyond the U.S., the medical establishments of other nations have not endorsed routine magnetic resonance image (MRI) screening, proposing that such a radiologic examination be reserved for two purposes: (i) for the woman with a suspected breast-implant rupture; and (ii) for the confirmation of mammographic and ultrasonic studies that indicate the presence of a ruptured breast implant. Furthermore, The Effect of Study design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging for Detecting Silicone Breast Implant Ruptures: a Meta-analysis (2011) reported that the breast-screening MRIs of asymptomatic women might be overestimating the incidence of breast-implant rupture. Nonetheless, the U.S. Food and Drug Administration emphasised that “breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications.”

Read more about this topic:  Breast Implant Controversy, Complications

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