Saline-filled breast implant safety and efficacy: a multicenter retrospective review.

Our center undertook an industry-funded, outcomes-based, multicenter, retrospective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre-market approval review process mandated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previously conducted by our center. For this study, several significant changes were made to our previous protocol, including improved patient tracking, stronger biostatistical support, and a mandatory 10-year minimum patient follow-up period. Physician-reported and patient-reported data on 450 patients with 882 saline-filled breast implants placed between January 1, 1980, and June 30, 1986, were obtained. Mean patient follow-up period was 13.0 years. Most implants (93.9 percent) were placed for breast augmentation. Seventy-four percent were placed in a submammary position; 25.6 percent, subpectorally; and 0.2 percent, subcutaneously. The overall complication rate was 20.2 percent. Reoperation for capsular contracture or implant deflation was necessary in 104 of 450 patients (23.1 percent). Deflation occurred in 73 implants (8.3 percent) and was underreported according to the physicians' record review alone. This deflation rate is higher than the 5.5 percent previously reported by our center. However, 26 of these 73 deflations (35.6 percent) occurred in a single cohort of patients at one center using Surgitek saline implants. If this cohort is excluded, the deflation rate drops to 5.8 percent, a figure more consistent with data published in the literature and found in our previous study. Of the 73 deflations, spontaneous deflation was reported for 50 (74.6 percent), and the remainder were iatrogenic. Actuarial survival of the non-Surgitek implants was 98.4 percent to 99.8 percent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent confidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heyer-Schulte and Mentor model 1800 implants (odds ratio = 3.0, p < 0.01), and implant size greater than 450 cc (odds ratio = 1.01, p < 0.02). Risk factors for capsular contracture included submammary implant position (odds ratio = 2.05, p = 0.03) and implant size greater than 450 cc (odds ratio = 1.01, p < 0.01). Overall, satisfaction was high: 93 percent of patients were "satisfied" or "very satisfied" with their implants. As in our earlier study, risk factors for patient dissatisfaction were reconstruction after mastectomy (odds ratio = 7.6, p = 0.011), significant breast firmness (odds ratio = 6.2, p < 0.001), and patient desire for smaller implants (odds ratio = 3.0, p = 0.020). In conclusion, our review provides additional outcomes-based evidence that saline-filled breast implants remain a safe, effective alternative to silicone gel-filled models.

Effects of capsular contracture on ultrasonic screening for silicone gel breast implant rupture.

Unlike computed tomography and magnetic resonance imaging, ultrasound is an inexpensive test of potential use in detecting silicone gel breast implant (SBI) rupture. However, periprosthetic capsular contracture can make ultrasonic diagnosis of rupture difficult because the contracture-related radial folds inside the SBI can lead to a false-positive diagnosis of rupture. This study was conducted to determine the effects of capsular contracture on the ability of ultrasound to diagnose SBI rupture. Preoperative ultrasonic results of 122 SBIs were compared with surgical findings at the time of implant removal. The sensitivity and negative predictive values of ultrasound were lower in the presence of a contracted capsule (41.2% vs. 68.7%, p = 0.062; and 58.3% vs. 79.6%, p = 0.056 respectively). Ultrasound should be considered reliable in diagnosing SBI rupture only in the absence of a contracted capsule.

Saline-filled breast implants: a Plastic Surgery Educational Foundation multicenter outcomes study.

In 1993, the Plastic Surgery Educational Foundation commissioned the senior author (Cunningham) to design an 11-center retrospective cohort outcomes study to obtain physician- and patient-reported data on saline-filled breast implants. Data were obtained from 504 patients with 995 saline-filled breast implants placed between January 1, 1980 and December 31, 1989, with a mean follow-up of 6 years. Most (93.8 percent) saline-filled breast implants were placed for breast augmentation. Of the 504 patients, 104 (20.6 percent) required reoperation for open capsulotomy or for replacement or removal of a deflated implant. Complications occurred in 22 patients (4.4 percent), with hematoma being most common. Implant deflation occurred in 55 implants (5.5 percent) and affected 51 patients (10.1 percent) but was underreported by chart abstraction alone. Risk factors for implant deflation included underfilling the implant by more than 25 cc (odds ratio 3.3, p = 0.0400), the use of model 1800 saline-filled breast implants (odds ratio 3.1, p = 0.0010), intraluminal antibiotics (odds ratio 2.6, p = 0.0183), and intraluminal steroids (odds ratio 2.4, p = 0.0711). Based on 44 of 55 saline-filled breast implants with known deflation dates, actuarial survival is 95.7 to 98.0 percent at 5 years and 90.2 to 95.2 percent at 10 years (95 percent confidence interval). Significant periprosthetic capsular contracture affected 103 patients (20.4 percent) during follow-up. Risk factors for capsular contracture included omitting intraluminal antibiotics (odds ratio 16.7, p = 0.0001), omitting intraluminal steroids (odds ratio 12.5, p = 0.0001), submammary placement of the saline-filled breast implant (odds ratio 7.8, p = 0.0001), and use of antibiotics in the implant pocket (odds ratio 6.1, p = 0.0001). Overall patient satisfaction with saline-filled breast implants was rated as high by 94.2 percent, and 94.8 percent of patients would choose saline-filled breast implants again. Dissatisfaction with their saline-filled breast implants was more frequent in patients with significant breast firmness (odds ratio 22.9, p = 0.0001), those undergoing prophylactic mastectomy (odds ratio 8.2, p = 0.0005), and those desiring smaller implants (odds ratio 6.9, p = 0.0001). In conclusion, saline-filled breast implants are a safe alternative to silicone gel-filled breast implants and demonstrate a high rate of patient satisfaction. Underfilling of saline-filled breast implants should be avoided because it contributes to deflation. Although intraluminal antibiotics and steroids protect against capsular contracture, they also contribute to saline-filled breast implant deflation. The incidence of capsular contracture is decreased by placing the saline-filled breast implant in the subpectoral position. Finally, patients should be aware of the possible need for reoperations related to their implants.

A study of the outcome of the American Society for Aesthetic Plastic Surgery research grant program.

Since 1974, the American Society for Aesthetic Plastic Surgery has funded a competitive research grant program jointly administered by the Plastic Surgery Educational Foundation. The grant program was initiated to provide "seed money" to researchers in aesthetic surgery. A written survey of all recipients over a 6-year period from 1985 to 1990 was conducted to assess the productivity of the grant program. The survey suggests that seed money grants are effective and that there is a high rate of peer-reviewed publication and national presentation of completed projects. Suggestions for improvement of the grant program are also presented.

Magnetic resonance imaging of the nose with surface coils: a new technique to evaluate functional and aesthetic problems.

Determining the preoperative functional and aesthetic anatomy has been of critical importance to surgeons planning nasal procedures. Beyond skilled clinical examination, few objective studies exist to aid the surgeon. Magnetic resonance imaging (MRI) represents a potentially excellent method for precise anatomic imaging of the nose. Unlike computed tomography (CT) and conventional x-rays, MRI involves no radiation. Similar to CT, however, MRI can provide computer-enhanced three-dimensional and quantitative airway data. Full-head MRI has proven sensitivity in evaluation of tumors of the brain and sinuses and is the imaging modality of choice for many soft-tissue tumors. Due to the relatively high cost of conventional full-head MRI scanning ($600 to $1200 per scan), MRI of the nose utilizing full head scanning technique has been limited. The recent development of small field of view surface coils has enabled higher-resolution nasal scans at a fraction of the scanner time and cost ($200 to $500) of conventional MRI scans. We have developed a protocol utilizing a small field of view coil which results in reproducible high-resolution nasal scans requiring less than 6 minutes of scanner time. This protocol has been used in both the diagnosis and follow-up of patients with traumatic and congenital nasal and septal deformities. Image resolution obtained using the protocol is significantly better than with conventional coils. This technique is excellent for both diagnosing and documenting nasal anatomy and pathology.

Quantitative analysis of lidocaine hydrochloride delivery by diffusion across tissue expander membranes.

Permeability of Silastic tissue expander shells to lidocaine was studied to investigate the feasibility of intraluminal lidocaine injection for pain relief during soft-tissue expansion. Both intact expanders and an apparatus using isolated Silastic membrane segments were used to partition solutions of various lidocaine concentrations, and the rate of diffusion was quantitatively measured using a fluorescence polarization immunoassay. Lidocaine flux was found to follow Fick's law of passive diffusion with respect to time, surface area, and concentration gradient for the first 9 hours, with a permeability coefficient of 10.3 +/- 2.6 micrograms (h.cm2.percent)-1 (mean +/- SD) and diffusion coefficient of 7.5 x 10(-7) cm2/min for an average membrane thickness of 473 +/- 23 microns. After 9 hours, the lidocaine flux decreased exponentially, although the concentration gradient across the membrane remained essentially the same order of magnitude. Plasma proteins in the outer bathing solution and methylparaben used as a preservative in the standard lidocaine formulation had no influence on the change in transport flux with time. At the end of the linear portion of the diffusion curve, less than 2 percent of the total intraluminal lidocaine had crossed the membrane. Potential toxicity in the event of implant rupture limits the maximum total lidocaine dose to approximately 500 mg within an expander at any one time. Within these limits, the capacity for lidocaine delivery of 500 mg lidocaine by a 640-cc tissue expander would be only 6 mg during the first 9 hours after administration.(ABSTRACT TRUNCATED AT 250 WORDS)

Intraluminal lidocaine for analgesia after tissue expansion: a double-blind prospective trial in breast reconstruction.

A double-blind prospective placebo controlled trial of intraluminal lidocaine for pain relief after tissue expansion was performed in 18 women undergoing breast reconstruction. In contrast to others' claims of effective analgesia, no difference in the incidence of immediate or late pain after expansion could be demonstrated between 100 mg of lidocaine and placebo. The overall incidence of early pain was 8%. This was significantly less frequent than late pain, which occurred after 36% of all expansions. Postexpansion pain (early or late) was reported after nearly one-half of all expansions, most of which was ascribed to late pain. The incidence of pain did not significantly depend on the temporal progression of breast expansion, nor was there a difference in the incidence and prevalence of pain for patients undergoing unilateral versus simultaneous bilateral expansion.

Malignant melanoma with evidence of maturation arising from a giant congenital nevocellular nevus.

The association between melanoma and giant congenital nevocellular nevus has been well documented, although controversy still exists regarding the precise incidence. The following patient report illustrates the excision of malignant melanoma arising from a giant congenital nevocellular nevus in a 4-month-old infant. The child had malignant melanoma with deep dermal involvement diagnosed by incisional biopsy with positive margins. She underwent subsequent en bloc resection of the original biopsy site and nevus. The reexcision specimen showed no evidence of malignancy. No adjuvant chemotherapy was used. The child is disease free at 5 years. It is possible that very young children (infants) with melanoma arising in a giant congenital nevocellular nevus may have a good prognosis.

Popliteal-based filleted lower leg musculocutaneous free-flap coverage of a hemipelvectomy defect.

A 33-year-old man suffered from locally recurrent malignant fibrous histiocytoma of his left thigh unresponsive to previous excision, radiation therapy, chemotherapy, and hyperthermic treatment. He underwent radical hemipelvectomy for cure. Because of extensive tumor involvement, a free flap consisting of his distal left leg based on the popliteal artery was utilized to close the defect. Both the tibia and fibula were removed from their periosteal sheaths, and the foot was excised from the flap. The popliteal artery and vein were anastomosed to the iliac vessels. The flap survived, and the patient was discharged home after physical rehabilitation. We suggest that uninvolved portions of the distal leg may be utilized as a free flap to successfully close hemipelvectomy defects in selected patients when conventional pedicle flaps are unavailable.

Chest-wall deformity after tissue expansion for breast reconstruction.

A prospective longitudinal study of chest-wall deformity after tissue expansion for breast reconstruction was performed in 19 women. CT imaging was a sensitive method for detecting occult deformity. Using a semiquantitative scale for measuring deformity, all patients and 94 percent of expanders had some thoracic abnormality after tissue expansion. Rib and chest-wall contour changes were observed under 81 and 68 percent of the expanders, respectively. Routine chest roentgenograms were not a sensitive method for evaluating these deformities. The magnitude of deformity after unilateral expansion was not significantly different from that after bilateral expansion. Linear regression analysis indicated that early periprosthetic capsular contracture was negatively correlated with chest wall deformity. Only one patient experienced a clinically noticeable complication from chest compression--transient postexpansion exertional dyspnea. After removing the expanders and placing permanent implants along with capsulotomy, the mean deformity index decreased by 57 percent after 10.5 months median follow-up, which was highly significant (p less than 0.001). Our findings suggest that chest-wall deformity is a common occurrence after tissue expansion in patients undergoing breast reconstruction and is usually of minor clinical significance.

Postmastectomy brachial plexus injury exacerbated by tissue expansion.

A neurapraxic injury to the brachial plexus was seen after modified radical mastectomy and immediate tissue expander placement. Neurological recovery proceeded until a sudden deterioration 42 hours after the fourth expansion. Deflation of the expander from an initial pressure of 18 mm Hg to 8 mm Hg led to relief from all acute symptoms, which were primarily in the distribution of the nerve most severely involved at the time of the initial injury, the median nerve. The history of previous neurapraxia and anatomical relationships between the tissue expander, pectoralis minor tendon, and neurovascular structures suggest that impairment of nerve function occurred through a compressive mechanism resembling a double-crush phenomenon.

The rectus abdominis muscle in difficult problems of hand soft tissue reconstruction.

When soft tissue losses in the hand require flap reconstruction, local tissue is preferred. Distant flaps should be reserved for major or unusually complex tissue losses which preclude the use of local flaps. We have used the rectus abdominis muscle as either a pedicled or a free flap with an overlying split thickness skin graft for several such complex soft tissue problems. Functional and cosmetic results have been excellent with minimal donor site morbidity. While not the initial choice for distant tissue used in hand reconstruction, the rectus abdominis muscle can solve several complex soft tissue problems in the hand.

Composite in situ vein bypass for upper extremity revascularization.

Chronic upper extremity arterial insufficiency is rare. Consequently, major reports specifically limited to the topic are scarce, and the clinical experience is small. In addition, symptomatology, diagnostic criteria, and guidelines for surgical management remain ill-defined. In the lower extremities, however, in situ vein bypass has been attempted for nearly three decades. This technique offers many advantages over traditional revascularization methods. Although the procedure has become popular for the lower extremity, no report of its use in the upper extremity is found in the literature. We report what may be the first case in which in situ bypass was used in the upper extremity for a threatened limb secondary to diabetic occlusive vascular disease complicated by a previous shunt used for hemodialysis. Revascularization of the upper extremity using the in situ vein bypass technique may offer a new alternative to traditional methods of revascularization.

Scalping injuries: new technique for stabilization of flaps to the skull.

Extensive scalping injuries offer a unique challenge for tissue coverage because of the wide expanse of bone and lack of deep soft tissue or significant perforating vessels. For smaller injuries, pedicle flaps offer ideal coverage. Larger defects can be covered by omental flaps. Coverage with a free muscle flap followed by split-thickness skin grafting offers optimal long-term coverage. Two new techniques are introduced. The wire-button technique offers stabilization, and the halo frame provides good support and protection for a new free-flap graft and may increase the success rate of flaps in patients with scalping injuries.

Use of the labial artery for replantation of the lip and chin.

A 12-year-old boy suffered from a full-thickness traumatic amputation of his lower lip and chin following a horse bite. Microsurgical technique was used to reanastomose the inferior labial artery and a vein of the chin. The replanted flap remained viable, and the patient has done well despite some early problems with eating and drooling. The patient is now able to purse his lips and has regained sensation and the use of his orbicularis oris and musculus mentalis, even though no attempt was made to repair the motor nerves or sensory nerves. Because of the potential superior cosmetic and functional results following replantation, we recommend aggressive microsurgical attempts at arterial and venous anastomosis not previously described following traumatic amputation. The inferior labial artery may be considered for use as a nutrient artery for replantation and in future elective maxillofacial reconstruction and free-flap transfer.

Use of streptokinase for the salvage of a free flap: case report and review of the use of thrombolytic therapy.

This is the first case report of the clinical use of intraoperative streptokinase to promote free flap salvage. A latissimus dorsi free flap was mobilized to cover a scalping type injury. After 4 1/2 hours of ischemia and recurrent thrombosis, streptokinase was perfused into the thoracodorsal artery (7,500 units of streptokinase in 30 cc of normal saline). The free flap was exposed to this concentration of streptokinase for 10 minutes followed by drainage of the venous effluent in order to avoid possible deleterious systemic effects of the streptokinase. Good flow throughout the free flap resulted, and the flap remained viable, providing good coverage for the patient's skull. Controversies regarding the no-reflow phenomena and the use of various thrombolytic agents are discussed.

Patient acceptance of dissociative anesthetics.

A prospective study was undertaken to evaluate the efficacy, safety, and patient acceptance of low-dose ketamine when used to diminish the pain of local anesthetic injections. The role of diazepam in preventing the untoward psychological effects of ketamine was also investigated. Our findings, derived from a postoperative questionnaire, reinforce the assertions of others, that ketamine is safe and effectively prevents pain in 85 percent of patients. While 13 percent of our patients hallucinated, most found the experience pleasant, and there were no "bad trips" or emergence reactions. Adequate premedication appears to be important in the successful use of ketamine. Whether sedation is augmented with diazepam or achieved with other medications does not appear to matter. A close supportive relationship with the surgeon and operating room personnel is probably as important as any pharmacologic manipulation in avoiding psychological mishap with low-dose ketamine.