A new chin implant for microgenia.

We describe our experiences with a new silicone bag-gel chin implant, developed in two phases over a 4-year period. Fifty patients received the Phase I implant, and such complications as internal and external soft tissue erosion, indentation, slippage, asymmetry, infection, andd late bone resorption (two cases) were seen. Subsequently 28 patients received the Phase II implant, and have been followed up to one year. So far, the only complication has been asymmetry in one case.     

Prospective evaluation of late cosmetic results following breast reconstruction: I. Implant reconstruction

The long-term cosmetic outcome of breast implant reconstruction is unknown. The morbidity and cosmetic outcome of 360 patients who underwent immediate postmastectomy breast reconstruction with various types of implants have been analyzed prospectively over a 9-year period. Of these patients, 334 who completed their reconstruction were suitable for evaluation of their cosmetic outcome. The early complication rate (< 2 months) was 9.2 percent, with an explantation rate of 1.7 percent. The late complication rate (> 2 months) was 23 percent, with a pathological capsular contracture rate of 11 percent at 2 years and 15 percent at 5 years and an implant removal rate of 7 percent. The revisional surgery rate was 30.2 percent.The cosmetic results were assessed prospectively using an objective five-point global scale. Every patient was scored at each visit once surgery was completed. The overall cosmetic outcome deteriorated in a linear fashion, from an initial acceptable result of 86 percent 2 years after patients completed their reconstruction to only 54 percent at 5 years. This decline in cosmetic outcome was not associated with the type of implant used, the volume of the implant, the age of the patient, or the type of mastectomy incision employed. Radiotherapy was not a significant factor because only 28 patients were irradiated. Upon Cox model analysis, pathological capsular contracture was the only factor that contributed significantly to a poor cosmetic outcome in which p < 0.0001 (relative risk 6.3). Despite a high revisional surgery rate, deterioration still occurred, suggesting that other unaccounted for variables were responsible. On photographic retrospective review of the patients without capsular contracture who demonstrated deterioration in their cosmetic scores, it became clear that a possible reason for their poor results was late asymmetry produced by the failure of both breasts to undergo symmetrical ptosis with aging.     

Delayed ectopic pregnancy following vaginal hysterectomy

A patient with ectopic pregnancy occurring a considerable interval after vaginal hysterectomy is reported. She presented with recurrent lower abdominal pain and the correct diagnosis was only established at laparotomy. Although 14 cases of this late complication of hysterectomy have been reported in the literature no fatalities have been recorded.     

Optimizing autologous breast reconstruction in thin patients

Breast reconstruction with a transverse rectus abdominis myocutaneous (TRAM) flap plus an implant has been proposed as an option for women with a thin body habitus who do not have sufficient abdominal tissue to permit reconstruction with a TRAM flap alone. The standard autologous tissue reconstructive procedure in these women is a combined latissimus dorsi myocutaneous flap and breast implant. We reviewed our experience performing TRAM flap/implant and latissimus dorsi flap/implant breast reconstruction to compare complication rates and aesthetic outcomes between these two types of reconstruction. Between 1992 and 1999, 88 breasts were reconstructed at our institution using an autologous tissue flap combined with a breast implant (44 with a TRAM flap/implant and 44 with a latissimus dorsi flap/implant). Recipient-site and donor-site complications for the two procedures were compared using Fisher's exact test; a panel of unbiased, blinded judges compared the aesthetic outcomes. The recipient-site complication rate was lower for the TRAM flap/implant group than for the latissimus dorsi flap/implant group (18 percent versus 34 percent, p = 0.09). Most recipient-site complications in the TRAM flap/implant group were related to fluid collection around the implant. In the TRAM flap/implant group, complications occurred in 37 percent of the reconstructions that had immediate implant placement and in none of the reconstructions with delayed implant placement (p = 0.01). In the TRAM flap/implant reconstructions with immediate implant placement, the recipient-site complication rate was 50 percent when implants were completely filled with saline, but no complications occurred with incompletely filled, postoperatively adjustable implants (p = 0.03). No microvascular complications occurred with immediate placement of breast implants under TRAM flaps. Donor-site complications included a hematoma, a seroma, and an umbilical necrosis in the TRAM flap/implant group and six cases of seroma formation in the latissimus dorsi flap/implant group. The comparison of aesthetic outcome was statistically significant for the TRAM flap/implant group, which had a higher overall mean score than the latissimus dorsi flap/implant group did (3.29 versus 2.85, p = 0.01). The results of this study suggest that the TRAM flap/implant breast reconstruction should be considered as an alternative to the latissimus dorsi flap/implant breast reconstruction in women with a thin body habitus.     

Salvage of infected expander prostheses in breast reconstruction

Periprosthetic infection is a devastating complication following breast reconstruction with prostheses. Traditional surgical principles dictate removal of the prosthesis to control infection. Although successful salvage of prostheses in the presence of periprosthetic infections has been reported in the plastic and other surgical literature, salvage procedures remain seldom practiced. Reports in the plastic surgery literature have been limited to implant salvage following cosmetic breast augmentation and subcutaneous mastectomy with implants. Salvage of saline-filled expander prostheses used in breast reconstruction following mastectomy for cancer has not been previously reported. The authors review their experience with implant salvage in patients with periprosthetic infections following breast reconstruction for a 6-year period. Fourteen patients (13 with saline-filled expander prostheses and one with silicone prosthesis) underwent implant salvage. Salvage of the breast reconstruction was successful in nine patients. Staphylococcus aureus infection was associated with poorer salvage rate (p = 0.023). Previous radiotherapy to the chest wall did not affect the salvage outcome (p = 0.50). In selected patients, immediate salvage of a breast reconstruction in the presence of prosthesis-related infection remains an alternative to implant removal followed by delayed reconstruction.     

Femoral neck fracture after removal of the standard gamma interlocking nail: a cadaveric study to determine factors influencing the biomechanical properties of the proximal femur

We retrospectively analyzed 1334 patients who were implanted standard gamma interlocking nails^® (SGN) to stabilize trochanteric femoral fractures over the years 1992–1998. Reoperation to remove the nails was performed in 37 patients, in 9 of them purely because of pain. Three out of these 9 patients with removed SGN suffered femoral neck fractures in the early postoperative course after having been mobilized to full weight-bearing capacity. This complication was not observed with other implant systems and, considering the notoriously high complication rate of femoral neck fractures, severely reduces the value of the SGN concept per se. These findings in combination with other known shortcomings of SGNs prompted us to conduct an experimental study on the fracture force of excavated femurs addressing the hypothesis that the specific design of the SGN is responsible for the occurrence of fatigue fractures of the femoral neck. Eighteen matched pairs of fresh human cadaveric proximal femurs, which were treated by insertion and removal of (i) SGNs or (ii) dynamic hip screws^® (DHS) or (iii) by excavation in the absence of an implant, were subjected to incremental loading cycles and compared to the untreated contralateral femurs. Overall, the fracture force was found to be significantly lower among the treated than among the untreated bones. However, the fracture force required after removal of the DHS system was still significantly higher than for SGN or excavation alone. In this way, our findings demonstrate that removing relatively big implants such as SGN can cause serious complications such as femoral neck fractures. We therefore recommend to leave this type of device in place even after fracture healing except in cases of deep and chronic infection.     

Finite element analysis of an additional implant for intramedullary nailing]

In the surgical treatment of fractured femurs, the fracture is bridged by a medullary nail fixed in the bone with interlocking screws. Failure of bone substance in the region of the interlocking screws is the most common complication in the treatment of osteoporotic bone. With the aim of preventing this complication, an additional implant was developed. A finite element analysis of an ideal bone/implant system was carried out to investigate the role of the additional implant. Three defined finite element models were generated, and the associated stress situations compared. The first model is a standard fixation without the additional implant. In the second model, the additional implant is integrated within the bone/implant system. The third model uses a modified form of the additional implant. The results show that both additional implants reduce the stresses occurring, both in the bone substance and at the screws. The modified form of the additional implant proved to be the most favorable version. In the case of the original additional implant, the negative effect of the sharp edges of the thread was demonstrable.     

Locally administered ketorolac and bupivacaine for control of postoperative pain in breast augmentation patients

With recent developments in the field of analgesia, the question arises whether there is a role for placing local anesthetics, nonsteroidal anti-inflammatory drugs, or both into the breast implant pocket. The objective of this study was to test the effectiveness of locally administered intraoperative ketorolac and bupivacaine with epinephrine at reducing pain in the postoperative period. The study was a prospective, randomized, double-blind clinical trial. One hundred consecutive retropectoral breast augmentation patients were enrolled, and informed consent was obtained. A standard anesthetic protocol and surgical procedure were followed. Normal saline, ketorolac alone (30 mg), bupivacaine alone (150 mg), or ketorolac and bupivacaine (30 mg and 150 mg respectively) were placed into the implant pocket before implant insertion. All patients completed the study. The power of this study to detect a 20 percent difference with respect to the primary outcome was 0.90 and confidence intervals of 95 percent were used to determine significance. The primary outcome was pain as measured by the visual analogue pain scale. The secondary outcome was time spent in the recovery room. Intraoperative placement of ketorolac combined with bupivacaine reduced pain in the postoperative period. It did not appear that anesthesiologist, anesthesia time, surgeon, operating room time, difficulty of dissection, breast incision, or implant size had a significant effect on postoperative pain. There was a trend that the ketorolac and bupivacaine patients spent less time in the recovery room and used fewer analgesics postoperatively than the other patients. There were no hematomas requiring reoperation and no complications. Locally administered intraoperative ketorolac and bupivacaine with epinephrine significantly reduced pain in the postoperative period.     

Prediction of lubrication regimes in wrist implants with spherical bearing surfaces

The wrist joint is frequently affected by rheumatoid arthritis, resulting in wrist pain, deformity and ultimately loss of function. Artificial wrist implants have been introduced to treat the rheumatoid wrist, to attempt to alleviate pain and restore some function to the joint. The aim of this study was to predict the likely lubrication regimes that occur in wrist implants with spherical bearing surfaces. The implant was modelled as an equivalent ball-on-plane. Elastohydrodynamic lubrication theory was used to determine the minimum film thickness for the implant under different load, entraining velocity, lubricant viscosity, size of implant and material combinations. The results show that the highest film thickness is found in large implants, with high viscosity, high entraining velocity and low load. Hard-on-soft material combinations will operate with a boundary lubrication regime. Material combinations involving ceramic bearing surfaces have the potential to operate with a mixed lubrication regime.     

Contraception with intrauterine devices

A review of the history of contraception with intrauterine devices, characteristics of present devices, and directions of current research is presented. The serious need for population control is not yet being met by today's inconvenient, ineffective, or unsafe methods. Intrauterine devices have been best for international family planning programs because they are cheap, easily installed, and provide continuous protection. There are many different models that have been and are being used, with different effectiveness and complication rates. The most commonly used today is the Lippes Loop, with a pregnancy rate of 2.8/100 years of woman use and an expulsion rate of 10.4. Most of these failures occur in the first few months of use, after which these rates are greatly reduced. The removal rate because of bleeding or pain for the Lippes device is 14.0. Other devices commonly used have pregnancy rates ranging 1.3-4.7, expulsion rates of 2.6-25.8, and removal rates of 13.5-22.1. Expulsion is directly related to the size and design of the IUD and the age and parity of t,e recipient. It is important to match the size of the device used to the individual characteristics of the patient. Research is seeking a design that will implant itself in the endometrium to resist expulsion, but not too deeply so that it is covered. Removal for bleeding and pain remains the most frequent complication of the IUD, and it partly depends on the skill of the inserting physician and how well the patient is psychologically prepared for side effects in the first months of use. Pregnancy is the most significant IUD complication. The key to an effective IUD is an understanding of its antifertility mechanism, which has thus far eluded researchers. The IUD prevents implantation of the blastocyst in the uterine wall, which may be due to a foreign-body reaction in the endometrium. IUDs with copper cause a greater reaction than plastic devices and provide hope for a very effective device; particularly the T-shaped design, which resists expulsion. The most promising new IUD is the Dalkon Shield. It has small projections that imbed in the endometrium and a broad surface for contact with the uterine wall. In preliminary experiments the pregnancy rate with this device was 1.1, the expulsion rate 2.3, and the removal rate 2.0, much lower than that with any other device yet developed. It is concluded that IUDs such as the Dalkon Shield can provide safe contraception with high effectiveness.     

Long-term stability of Teflon orbital implants

Teflon orbital floor implants have become controversial owing to reports of implant-related complications. To determine the actual incidence of Teflon implant-related complications and factors associated with complications, we conducted a long-term follow-up study of 77 selected patients. We obtained data on 35 implants in 31 patients with a mean follow-up period of 16 years, representing an experience of 528 patient-implant years. The short-term complication rate (within 1 month of surgery) was 3.9 percent. The long-term complication rate was 2.8 percent. Concomitant antral packing and implantation of Teflon sheet were associated with a markedly higher risk of implant pocket infection. There was no case of implant migration with proper fixation. Facial growth was normal in three children in the series. We conclude that Teflon sheet is well-tolerated in the orbit in the long term. The low complication rate can be further reduced with proper fixation of the implant and avoidance of antral packing at the time of implantation.     

Porous, block hydroxyapatite as an interpositional bone graft substitute in orthognathic surgery

Forty-six nonconsecutive patients undergoing orthognathic surgery in whom blocks of coralline, porous hydroxyapatite (Interpore-200) were used in lieu of interpositional bone grafts are the subjects of this report. Surgical procedures included inferior repositioning of the maxilla (7) and chin (12), maxillary advancements in cleft (4) and noncleft individuals (13), and transverse maxillary expansions (12). Patients included in this study were only those in whom bone grafts would have been harvested had hydroxyapatite not been available. A total of 93 anatomic sites were implanted. The complication rate attributable to the use of the implant was 4.3 percent. Follow-up period ranged from 6 to 20 months, with a mean of 9.3 months. At this time, osseous stability was confirmed cephalometrically in all but two patients undergoing maxillary expansions. The biologic behavior and mechanical properties of coralline-derived, porous, block hydroxyapatite are discussed. These implant characteristics make it a feasible bone graft substitute for interpositional use in orthognathic surgery. Proper indications for its use as well as technical details to minimize complications are stressed.     

Intraductal extension of silicone from a ruptured breast implant.

Silicone rupture is a known complication of closed capsulotomy. Imaging of silicone within breast tissue after rupture of an implant is not uncommon. Intraductal extension of silicone on mammography is a very rare finding. This case report described the imaging features of silicone within the breast tissue and ducts that necessitated subcutaneous mastectomy for definitive treatment.     

Air entrapment as a cause of early inappropriate shocks after subcutaneous defibrillator implant: A case series

Inappropriate shock (IAS) is the most frequent device-related complication among patients with subcutaneous implantable cardioverter-defibrillator (S-ICD). Air entrapment (AE) has been described as an underdiagnosed cause of early postimplant IAS. We report 6 consecutive cases of early IAS after S-ICD implant, in whom the electrogram analysis (EGM) and/or chest radiography (CXR) were consistent with AE.     

Prognosis in giant-cell arteritis.

In a study to assess the natural history of giant-cell arteritis, 90 patients with proved disease were followed up from the time of diagnosis. Early mortality was low and most commonly due to vertebral arteritis, but cerebral infarction did not appear to be a late complication. High maintenance dose steroids and visual loss were associated significantly with a shortened life span (p=0.0003 and p=0.0024). One-third of the patients developed chronic relapsing disease, but serious late complications were not encountered. After the initial attack has been controlled steroid dosage should be reduced to the minimum needed to alleviate symptoms.     

Pain Perception Is Increased in Congenital but Not Late Onset Blindness

There is now ample evidence that blind individuals outperform sighted individuals in various tasks involving the non-visual senses. In line with these results, we recently showed that visual deprivation from birth leads to an increased sensitivity to pain. As many studies have shown that congenitally and late blind individuals show differences in their degree of compensatory plasticity, we here address the question whether late blind individuals also show hypersensitivity to nociceptive stimulation. We therefore compared pain thresholds and responses to supra-threshold nociceptive stimuli in congenitally blind, late blind and normally sighted volunteers. Participants also filled in questionnaires measuring attention and anxiety towards pain in everyday life. Results show that late blind participants have pain thresholds and ratings of supra-threshold heat nociceptive stimuli similar to the normally sighted, whereas congenitally blind participants are hypersensitive to nociceptive thermal stimuli. Furthermore, results of the pain questionnaires did not allow to discriminate late blind from normal sighted participants, whereas congenitally blind individuals had a different pattern of responses. Taken together, these results suggest that enhanced sensitivity to pain following visual deprivation is likely due to neuroplastic changes related to the early loss of vision.     

Randomized Clinical Trial Comparing Ultrasound-Guided Procedure with the Seldinger’s Technique for Placement of Implantable Venous Ports

The aim of this randomized controlled study was to compare ultrasound-guided procedure with the Seldinger’s technique for placement of implantable venous ports. A total of 214 patients were randomized to receive TIAP placement by either ultrasound-guided procedure or the Seldinger’s technique. Complications and pain perception were compared between these two groups. No severe perioperative or periinterventional complication occurred. Significantly (P < 0.05) lower pain perception was observed in the ultrasound-guided group. Seldinger’s technique group showed higher rate in incidence of early and late complications including catheter dislocation, catheter occlusion, venous thrombosis, fever of unknown origin, skin necrosis, and sepsis. In conclusion, both techniques, the TIAP implantation via ultrasound-guided jugular vein puncture and via Seldinger’s technique subclavian vein puncture, are feasible and safe. Regarding intrainterventional pain perception and implantation-related complications, the jugular vein puncture under ultrasound guidance seems to be advantageous.     

Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study

In this study, the effects of procedure type, timing, and other clinical variables on complication rates in mastectomy reconstruction were prospectively evaluated. Using a prospective cohort design, women undergoing first-time, immediate or delayed breast reconstruction were recruited from 12 centers and 23 plastic surgeons. Complication data for expander/implant, pedicle transverse rectus abdominis musculocutaneous (TRAM) flap, and free TRAM flap procedures were evaluated 2 years after surgery in 326 patients. For each patient, the total number of complications was recorded and the complication data were dichotomized in two ways: (1) total complications and (2) major complications (those requiring reoperation, rehospitalization, or nonperioperative intravenous antibiotic treatment). The effects of procedure type, timing, radiotherapy, chemotherapy, age, smoking, and body mass index on complication rates were analyzed using logistic regression. Immediate reconstructions had significantly higher total as well as major complication rates, compared with delayed procedures (p = 0.011 and 0.005, respectively). Furthermore, higher body mass indexes were associated with significantly higher total and major complication rates (p = 0.005 and p < 0.001, respectively). No significant effects on complication rates were noted for procedure type or for the other independent variables, although there was evidence of trends for higher total and major complication rates in implant patients who received radiotherapy and a trend for higher major complication rates in TRAM flap patients who received chemotherapy. It was concluded that (1) immediate reconstructions were associated with significantly higher complication rates than delayed procedures, and (2) procedure type had no significant effect on complication rates.     

Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants

Concern has been expressed over the long-term integrity of silicone gel breast implants. There are no large series representing experience with these implants outside of the United States. A retrospective case note review of explanted silicone breast implants was performed; 478 implants have been explanted during the past 11 years and relate to the use of these devices since 1971. Loss of implant integrity was not simply related to its age in vivo. Failure was more likely with implants of the late 1970s and early 1980s (second generation) and with subpectoral placement. Implant failure was independent of capsular contracture as the indication for removal (p = 0.09). There is no evidence that the currently used textured silicone gel breast implants are subject to the same loss of integrity as previous examples of these devices. The life span of these implants, the first of which are approaching 10 years in vivo, is at present unknown. Information concerning the integrity of silicone gel breast implants is essential in the current climate for counseling of both new and old implant recipients.