USA-FDA Approved Implants


In the Allergan core study, ruptures will assess the patients who had MRI screening for silent ruptures. The rupture rate in MRI cohorts is 8.6% for primary augmentation, 11.4% for primary reconstruction. The rupture rate for the entire MRI cohort through 7 years is 7.3% for patients and 4.5% for implants. All of these ruptures through the Natrelle Core Study were intracapsular. The average of the implant was approximately 11 years old. Silent ruptures were found at 50% of the combined group of augmentation reconstruction and revision patients in 8% of all implants.


According to MRI screening for silent ruptures for primary augmentation, the rupture rate was .5% through 3 years. This means through three years, one of every 200 augmentation mammoplasty patients had at least one ruptured breast implant. For revision patients in the MRI cohort, the rupture was 7.7% after three years. This means through three years, one of every 13 revision augmentation patients had at least one ruptured implant. Although these implant ruptures were silent, they were detected via MRI. The rupture rate beyond three years in Mentor’s Core Study continues to be investigated. The local breast complications associated with rupture included hardness, change in breast shape, size and breast pain. The symptoms are now specific to ruptures as they are also experienced by women who had capsular contracture. Concerns have been raised over whether ruptured implants are associated with development of connective tissue, rheumatic diseases and/or symptoms such as fatigue and fibromyalgia. A number of epidemiological studies evaluated large populations of women with implants. These studies did not show an increase incidence of autoimmune disease or increase incidence of breast cancer. The ruptures of the Mentor silicone implants were found to be silent. That means that neither you nor the surgeon would detect the rupture at that time. In fact, the ability of a physical examination was difficult in detecting rupture. Screening MRIs were shown to be effective for detection of silicone rupture with Mentor implants.


The rupture of a silicone gel implant may be silent or asymptomatic. Patients should undergo MRIs every two to three years with the Sientra implants. If the rupture is noted on MRI then he should advise the patient to have implants removed and replaced. Patients who undergo MRI with a 1.5 Tesla magnet dedicated for breast imaging and radiologists who are experienced to read breast implant MRIs looking for a positive Linguine sign. As per Sientra, implants are not considered lifetime devices. Patients will undergo implant removal and replacement over the course of their life. Sientra implants are new to being FDA-approved in 2012. Future studies and rupture rates will be determined.