Results from the MemoryGel Post-approval Study.

The approval of Mentor MemoryGel Breast Implants in November 2006 was conditional on conducting a 10-year study designed to collect long-term experience in US women with MemoryGel Breast Implants, known as the MemoryGel Post-Approval Study. METHODS: This prospective, observational 10-year follow-up study used a current cohort design that began in 2007, which included both MemoryGel Breast Implant participants and concurrent saline controls to assess rheumatologic and neurologic signs and symptoms. The protocol was amended in 2015, which limited the scope of further data collection for the study to only secondary procedure/re-operation data for MemoryGel participants. RESULTS: Primary augmentation (n = 6743), revision augmentation (n = 2071), primary reconstruction (n = 1763), and revision reconstruction (n = 557) participants were enrolled in the Re-operation Phase Safety Set. Kaplan-Meier-estimated 10-year cumulative incidence of re-operation and explantation on a participant-level were 10.5% and 4.2% (primary augmentation), 14.1% and 7.7% (revision augmentation), 20.8% and 12.8% (primary reconstruction), and 25.0% and 16.6% (revision reconstruction). CONCLUSIONS: The Re-operation Phase of the post-approval study addressed the Kaplan-Meier implant removal and re-operation rates over time, and provided the reasons for re-operation over time. Overall, no significant new hazards, increased risk, or unexpected adverse events were identified in the MemoryGel Post-Approval Study Re-operation Phase Safety Set.

MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up.

BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits.

BACKGROUND: The relative risks and benefits of various textured breast implants are the focus of considerable discussion. Studies have suggested different risk-benefit profiles for different implant surface topographies. OBJECTIVES: The study aim was to provide device-specific, quantitative information on Mentor's imprinted Siltex Textured breast implants with respect to textured surface characteristics and ISO 14607 classification, risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and risk-reduction benefits relative to smooth implants. METHODS: Surface metrology was performed. Data for smooth and Siltex implants from the prospective MemoryGel Core Study were evaluated by Kaplan-Meier analysis for the most frequently occurring postoperative complications in augmentation and reconstruction leading to subsequent reoperation. RESULTS: The overall average surface roughness for Siltex MemoryGel and MemoryShape implants was 29.5 and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex compared with smooth devices over 10 years was observed for both capsular contracture in subglandular primary augmentation patients (4.21% vs 19.84%) and for asymmetry in primary reconstruction patients (3.88% vs 11.1%). CONCLUSIONS: Surface analysis demonstrated that Siltex implants fall within the ISO 14607 category of "microtexture" breast implants. These devices exhibited a rare risk of BIA-ALCL (0.0012%) based on the most extensive data available. Relative to smooth implants, these Siltex devices provided risk-reduction benefits for the most common reason of reoperation in patients who underwent primary augmentation (capsular contracture) or primary reconstruction (asymmetry) in the Core Study. These findings provide valuable risk-benefit information for surgeons and their patients.

Breast Implant Engineering and Performance.

The engineering of breast implants for both augmentation and reconstruction is centered on facilitating optimal aesthetic results pleasing to the patient, while minimizing both short- and long-term complications. Some of the key individual design elements that have been the primary focus over time have included gel cohesivity, shell thickness, shell surface, and implant gel fill. A review of these separate elements points to the potential benefits of increased focus on a combined overall performance perspective for engineering of new implants as exemplified in the recently introduced MemoryGel Xtra Breast Implants. Such an approach is expected to provide an improved and expanded range of options to facilitate obtaining desired aesthetic outcomes and long-term clinical performance.

Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years.

BACKGROUND: Contour Profile Gel/MemoryShape breast implants consist of a textured silicone elastomer shell filled with silicone gel. The objective of this clinical study was to assess the safety and effectiveness of Contour Profile Gel/MemoryShape breast implants in women who were undergoing primary breast augmentation, primary breast reconstruction, or revision surgery (revision-augmentation or revision-reconstruction). METHODS: This was a prospective, open-label, multicenter clinical study involving Contour Profile Gel/MemoryShape breast implants in 955 female subjects, including 572 primary augmentation, 124 revision-augmentation, 190 primary reconstruction, and 69 revision-reconstruction subjects. Safety was assessed based on the incidence, severity, and method of resolution of all complications. Endpoints were examined on both a per-subject and a per-implant basis. RESULTS: For the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, the Kaplan-Meier estimated 10-year cumulative incidence rates for the key complications at the subject level were as follows: Baker grade III/IV capsular contracture, 3.6 (primary augmentation), 15.5 (revision-augmentation), 14.3 (primary reconstruction), and 16.4 (revision-reconstruction) percent; infection, 0.7 (primary augmentation), 1.9 (revision-augmentation), 1.6 (primary reconstruction), and 2.9 (revision-reconstruction) percent; explantation with or without replacement, 9.2 (primary augmentation), 25.9 (revision-augmentation), 34.1 (primary reconstruction), and 49.0 (revision-reconstruction) percent; explantation with replacement with study device, 4.0 (primary augmentation), 10.8 (revision-augmentation), 16.7 (primary reconstruction), and 27.9 (revision-reconstruction) percent; and any reoperation, 22.3 (primary augmentation), 35.0 (revision-augmentation), 52.7 (primary reconstruction), and 59.7 (revision-reconstruction) percent. CONCLUSION: The results of this study demonstrate that Contour Profile Gel/MemoryShape breast implants are safe and effective for primary and revision breast augmentation and reconstruction for women at least 22 years old.

Over Troubled Water: An Outbreak of Infection Due to a New Species of Mycobacterium following Implant-Based Breast Surgery.

Mycobacterial infection is a rare complication associated with breast surgery using implants. Over the course of 5 months, one center experienced 12 such cases, 10 of which were linked to a single surgeon. Most presented 3 to 6 weeks postoperatively with clear serous drainage from the incision, minimal local redness, no fever or other systemic signs of infection, and negative standard bacterial cultures. Patients were given empiric broad-spectrum oral antibiotic therapy. In eight cases, implants were removed and exchanged for new devices after irrigation of the pocket with antibiotics; these patients nonetheless experienced recurrent infection, which led to explantation (without immediate exchange for new implants). The last two patients proceeded straight to explantation. Because mycobacteria grow in water, the water supply and air-conditioning system were initially suspected as the source, and both were disinfected. However, this did not stop the outbreak. Eventually, the source was traced to a new species of mycobacteria isolated from a garden hot tub. These bacteria had then been unwittingly transferred to patients during surgery. A Triclosan-containing shampoo effectively ended the outbreak. This series is unique in several respects: the novelty of the pathogen, the heavy colonization of the surgeon, and the mechanism of transmission (the first occurrence of human-to-human mycobacterial transfer published in the plastic surgery literature). Surgeons who perform breast surgery with implants should be aware of the possibility of mycobacterial infection. Proactive culturing of the organism, use of antibiotics, and reoperation are essential to good outcomes.

Risk of breast implant bacterial contamination from endogenous breast flora, prevention with nipple shields, and implications for biofilm formation.

BACKGROUND: Capsular contracture (CC) is a common complication of breast augmentation that is thought to arise from bacterial contamination and subsequent biofilm formation on the implant. Endogenous breast flora expressed through the nipple may contaminate the sterile field during breast augmentation, acting as a possible source for initiation of biofilm formation. OBJECTIVES: The authors investigate the incidence of nipple bacterial contamination with endogenous breast flora after standard chest wall sterilization during breast augmentation. METHODS: Bacterial contamination of nipples and nipple shields was assessed in a series of 32 consecutive patients presenting for breast augmentation (63 breasts: 31 bilateral procedures and 1 unilateral procedure). After standard sterilization of the chest wall, occlusive nipple shields were applied and breast augmentation was performed. At the conclusion of breast augmentation, the nipple shields were removed and, using the same swab, both the nipple/areolar area and occlusive dressings were cultured. RESULTS: Data from 63 cultured nipples and nipple shields revealed that 22 nipples/nipple shields (34.9%) were positive for bacterial contamination. Three patients, all of whom had negative cultures, developed CC after augmentation. CONCLUSIONS: The exposed nipple is a potential source of implant contamination during breast augmentation. An improved understanding of biofilms and related risk factors for CC can provide surgeons with insights for addressing this common complication. Meticulous hemostasis, use of nipple shields, and submuscular device placement may contribute to a lower incidence of CC.

Approaching temporomandibular disorders from a new direction: a randomized controlled clinical trial of the TMDes ear system.

TMDes (Registered Trademark of Ascentia Health, Inc., Rockford, Illinois), custom-fit ear inserts to aid in reducing temporomandibular disorder (TMD) pain, were evaluated in a prospective, three-month, open-label, three-arm, randomized, unblinded clinical trial, which included patients with TMD diagnoses (RDC/TMD) of myofascial pain, arthralgia, and/or disc displacement with reduction; and a screening VAS pain score of > 4. The three treatment groups included: TMDes (n = 60), stabilization splint (n = 64), and jaw exercise regimen (n = 28). The mean change in Craniomandibular Index (CMI) scores (reductions reflecting improvement) from baseline to one month were -27% (TMDes), -20% (stabilization splint), -12% (jaw exercise regimen), and from baseline to three months were -45%, -41%, -36%, reflecting statistically significant noninferiority (p = 0.0096) of the TMDes to the stabilization splint (primary efficacy endpoint). The TMDes produced significant (p < 0.0001) mean changes in VAS pain scores from baseline of -46% at one month and -58% at three months and demonstrated comparable efficacy and safety to the stabilization splint.

Silicone breast implants and platinum.

Platinum, in a specific form, is used as a catalyst in the cross-linking reactions of the silicone gel and elastomer in breast implants. After manufacture, it remains in the devices at low-parts-per-million levels. Potential concerns have been raised as to whether this platinum might diffuse from silicone breast implants into the body and result in adverse health effects. The weight of evidence indicates that the platinum present is in its most biocompatible (zero valence) form, and the very minute levels (<0.1 percent) that might diffuse from the implants do not represent a significant health risk to patients.