The relationship of human acellular dermal matrix thickness on complication rate and patient-reported outcomes in implant-based immediate breast reconstruction.

BACKGROUND: As it can be said that prosthetic breast reconstruction has been increased by the use of acellular dermal matrices (ADMs), ADMs are widely used in implant reconstruction. A large variety types of ADMs are now produced, but there is a paucity of data comparing the ADM products directly. We evaluated the effects of ADM thickness on complication rates and patient satisfaction after dual-plane subpectoral ADM-assisted implant breast reconstruction. METHODS: A retrospective study of patients who underwent immediate implant breast reconstruction using ADM was performed. We compared clinical course and postoperative outcomes for two ADM groups with different thicknesses [thin ADMs, 0.6-1.5 mm (group 1) vs. thick ADMs, 1.5-3.0 mm (group 2)] based on the incidence of complications and the duration of drainage. Patient satisfaction was also evaluated using the Breast Questionnaire (BREAST-Q), 6 months after surgery. RESULTS: A total of 51 patients were included in the study (group 1, n=21; group 2, n=30). Patient demographics were similar between the two groups, and no difference in postoperative complication rate (P>0.05) and Jackson-Pratt (JP) drainage durations (P>0.05). On regression analysis, ADM thickness was not an independent factor for any complication subtype. There were also no significant differences in BREAST-Q results, across all metrics, between the study groups. CONCLUSIONS: In dual plane subpectoral implant placement breast reconstruction with an inferior ADM-sling, the thickness of ADM was not a factor in determining postoperative complications and patient satisfaction. Therefore, it is possible to select the thickness according to the surgeon's preference.

A Comparative Analysis between Subpectoral versus Prepectoral Single Stage Direct-to-Implant Breast Reconstruction.

Background and objectives: Until now subpectoral breast reconstruction (SBR) has been the predominant form; however, it can present with pectoralis muscle contraction and animation deformity. To avoid these complications, surgeons have begun placing breast implants in the same anatomic space as the breast tissue that was removed. We report a comparative analysis of prepectoral breast reconstruction (PBR) versus subpectoral breast reconstruction to analyze their differences. Materials and Methods: Direct-to-implant (DTI) reconstruction using acellular dermal matrix (ADM) performed from February 2015 to February 2020 were retrospectively reviewed. We then compared the clinical course and postoperative outcomes of the two groups (prepectoral vs. subpectoral) based on the overall incidence of complications, pain scale, and the duration of drainage. Results: A total of 167 patients underwent unilateral DTI, with SBR 114 (68.3%) and PBR 53 (31.7%). Patient demographics were similar between the two groups. There was no statistically significant difference in rates of seroma, infection (requiring intravenous antibiotics), hematoma, and skin necrosis. Implant loss rates in the SBR 6.1% (n = 7) and PBR 9.4% (n = 5) were also not statistically significant (p = 0.99). The hemovac duration period was significantly longer in the SBR (14.93 ± 5.57 days) group than in the PBR group (11.09 ± 4.82 days) (p < 0.01). However, post-operative pain scores are similar between two groups, although it is not clear whether this was due to the effect of postoperative patient-controlled analgesia. Conclusions: A SBR is a commonly used procedure with various advantages, but there are many problems due to damage to the normal pectoralis major muscle. According to the results of our study, the PBR group had a shorter hemovac duration period compared to the SBR group, although there was no significant difference in complication rate. A PBR is a simple and safe technique allowing early discharge without increasing the incidence of long-term complications.

Funnel usefulness in direct-to-implant breast reconstruction using periareolar incision with prepectoral implant placement and complete coverage with acellular dermal matrix.

BACKGROUND: The funnel has been used in esthetic breast surgery that requires a small incision. Recent advances in minimally invasive surgical techniques have led to more cases of nipple-sparing mastectomy (NSM) through periareolar incision. However, prepectoral implant placement and complete coverage with acellular dermal matrix (ADM) is almost impossible with the periareolar approach. Funnels can also be useful for direct-to-implant breast reconstruction. METHODS: NSM with periareolar incision and direct-to-implant breast reconstruction were performed with prepectoral implant placement between January 2017 and July 2019. The ADM full-wrapped anatomic textured implant was inserted using a funnel without additional incisions during surgery. RESULTS: A total of 21 patients were enrolled, including 2 who received bilateral breast reconstruction. All operations were successfully performed using funnels with minimal periareolar incisions. Anatomic textured implants (mean: 251.7 cc, range: 90-450 cc) wrapped in ADM can be effectively inserted in the prepectoral plane using a funnel. Two patients experienced delayed wound healing of the areola that was treated by conservative wound management. Patients also experienced less pain overall, and the cosmetic result was very good. Patient satisfaction scores were also very high. CONCLUSIONS: While the periareolar incision is esthetically pleasing, additional resection is often necessary. However, the use of funnels ensured that no additional incision was needed even in large implants. This subsequently led to better results in terms of pain and scarring. Prepectoral breast reconstruction involving complete implant coverage with ADM using a funnel through the periareolar approach represents a good alternative to the traditional dual plane subpectoral method. This method provides good patient satisfaction without adverse outcomes.

The influence of contralateral breast augmentation on the development of complications in direct-to-implant breast reconstruction.

BACKGROUND: Simultaneous contralateral augmentation in direct-to-implant (DTI) breast reconstruction may increase the risk of skin flap necrosis on the reconstruction side due to increased tension on the skin flap when implants are larger than the original breast size. The purpose of this study was to evaluate whether the contralateral augmentation procedure affects complications in unilateral DTI breast reconstruction. METHODS: Patients who underwent immediate unilateral DTI breast reconstruction from January 2013 to July 2017 were included in this study. Data were collected through retrospective review of individual medical records. The primary outcome variable was the development of perioperative complications including skin flap necrosis. Univariable and multivariable logistic regression analyses were performed to identify risk factors for complications. RESULTS: A total of 121 patients who underwent unilateral immediate DTI breast reconstruction were included in this study. Twenty-one patients (17.4%) underwent simultaneous contralateral augmentation mammoplasty and 100 patients (82.6%) underwent DTI without contralateral augmentation. Overall complications were not different between the contralateral augmentation and no-augmentation groups (23.8% vs. 31%, respectively, p = 0.512). The frequency of skin flap necrosis in the augmentation group (14.3%) was not significantly different from that in the no-augmentation group (18.0%, p > 0.999). In multivariable analysis, mastectomy weight was the only predictor for complications (p = 0.053) and contralateral augmentation was not associated with development of complications. CONCLUSION: Contralateral breast augmentation in DTI breast reconstruction is not a risk factor for complications and can be safely performed in selected patients.

Nipple-sparing mastectomy through periareolar incision with immediate reconstruction.

PURPOSE: Nipple-sparing mastectomy (NSM) has become increasingly popular due to improved cosmesis without compromising oncologic safety. Radial and inframammary incisions are usually used to achieve NSM, with periareolar incisions usually being avoided because of the risk to nipple-areola complex viability. In an attempt to maximize esthetic effects, we performed NSM through periareolar incision with immediate reconstruction. We report our initial experience. METHODS: This case series consisted of all consecutive patients (n = 34) who underwent NSM through a periareolar incision in our institution between August 2017 and December 2018. All patients underwent NSM through periareolar incision followed by immediate reconstruction with an implant or deep inferior epigastric perforator flap. Patient demographics, tumor and treatment characteristics, and short-term postoperative outcomes were reviewed. RESULTS: The mean patient age was 46.74 ± 6.69 years (range, 38-62 years), and the mean operation time was 96.68 ± 28.00 minutes. Indications included in situ cancer in 12 cases and invasive cancer in 22 cases. There was 1 major complication (postoperative hematoma) requiring operative reintervention. No other complications including fistula, implant exposure, or reconstruction failure was observed. At the time of writing, no case of local recurrence has been observed. CONCLUSION: Our initial report shows that NSM with immediate reconstruction may successfully be performed through periareolar incision. This method maximizes esthetic effects and may be an appropriate surgical option for NSM.

Effect of Human Placental Extract Treatment on Random-Pattern Skin Flap Survival in Rats.

Background: Human placental extract (HPE), prepared from the placentas of healthy, postpartum females, displays various physiological activities, including antioxidative properties. In this study, a dorsal skin flap model was used to investigate the effect of HPE on flap viability in rats. Materials and methods: Forty male Sprague-Dawley rats underwent random-pattern skin flap surgeries. The animals were randomly divided among a control group and three treatment groups (localized injection (LI), 10 mg/kg/d localized HPE injections; low-dose treatment (LT), 10 mg/kg/d systemic HPE injections; high-dose treatment (HT), 40 mg/kg/d systemic HPE injections). Surviving skin flap areas were measured 7 days after surgery and tissue samples were stained with hematoxylin and eosin; vascular endothelial growth factor expression was determined immunohistochemically. To evaluate the antioxidant and antiapoptotic effects of HPE, malondialdehyde, glutathione peroxidase, and caspase-3 levels were examined. Results: Seven days after surgery, HPE-treated animals had significantly reduced necrotic areas, rats receiving the highest HPE dose demonstrated the greatest flap survival. In the HPE groups, the histopathological scores were lower than for the control group. Immunohistochemistry showed markedly more numerous vascular endothelial growth factor-positive cells in the HT group than in the C group. Malondialdehyde levels were significantly lower and glutathione peroxidase levels were higher in the HT group than in the C group. HPE treatment significantly inhibited apoptosis by lowering caspase-3 activity. Conclusions: HPE treatment yielded positive effects on flap survival, due to its antioxidant and antiapoptotic properties. These results suggest a new therapeutic approach for enhancing flap viability and accelerating wound repair.

Is the "ghost surgery" the subject of legal punishment in Korea?

PURPOSE: Recently a controversy has arisen about so-called "ghost surgery" practices, and people have voiced their opinions for legal sanction against such practices, which clearly undermine the foundation of medical ethics. However, there has been a lack of legal basis for punishing those actions. The present study aims to examine which pre-existing legal provisions could be applied to regulate ghost surgery. METHODS: The Korean Medical Service Act has a provision relating to informed consent to inhibit ghost surgery but does not include penalty provisions prohibiting ghost surgery itself. Also, the Korean Supreme Court precedents on this issue have not been settled as of yet. Therefore, this study referred to U.S precedents, law books, and related papers. RESULTS: With respect to ghost surgery, we expect the charges of bodily harm, assault and battery, and fraud could be applied under Korean law, in addition to charges regarding the violation of medical law, such as the omission of entries or false entries in medical records. A patient provides consent to bodily harm prior to surgery, and only the person who is entrusted with such permission can become the operating surgeon in the operating room. CONCLUSION: In other words, even if other medical professionals are present in the operating room, the operating surgeon who received consent must take overall responsibility for the whole process of the surgery. A surgeon should bear in mind that a violation of such duty can constitute a criminal offense.

Judicial Precedent-Based Clinical Practice Guidelines of Propofol in Sedative Esthetic Surgery.

BACKGROUND: Propofol is has been widely used for sedation in the field of esthetic surgery because of its favorable pharmacokinetic profile. Propofol sedation-induced side effects are rare. However, when present, they can be serious. The number of malpractice claims associated with propofol sedation has increased in recent years. This study aims to show which procedures lead to the most claims in the field of esthetic surgery through a review of Korean precedents. METHODS: Thirteen precedent cases of propofol sedation in the field of esthetic surgery were collected between 2000 and 2016. We analyzed the type of procedure, administration route, anesthesia provider, complications, timing of damaging events, average indemnification, plaintiff's (patients) winning rate, ratio and the reason of limitation of liability and the key factors affecting the judgement in these cases. RESULTS: Most plaintiffs were women, and in most cases (11/13, 73.3%), the times of the damaging events were in maintenance and the anesthesia provider was the surgeon. The most common complication related to propofol sedation was hypoxic brain damage. Among the 13 cases, 12 were won by the plaintiff. The mean claim settlement was 339,455,814 KRW (USD 301,792.15). The key factors affecting the judgement were administration method and staff, monitoring method, preparation of emergency kit, response to emergencies, transfer to a higher-level hospital, detailed medical recording about event and informed consent. CONCLUSION: The number of claims owing to propofol sedation after esthetic surgery is increasing. Close monitoring during the operation, immediate reaction to an event and thorough medical records were main key factors that influenced the judgement. Preoperative explanation about the possibility of complications was important. The findings will help surgeons achieve high patient satisfaction and reduce liability concerns. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Analysis of the Legal Effect of Settlement Agreements Prepared in Medical Litigation Following Plastic Surgery in Korea.

BACKGROUND: Settlements between doctors and patients provide a solution to complicated disputes. However, some disputes may be renewed as a result of negligence by both parties. The purpose of this study was to review the legal issues that may potentially arise during the preparation of settlement agreements and to propose a list of requirements for ensuring the effectiveness of these settlement agreements. METHODS: Data from 287 civil cases concerning aesthetic surgery that took place between 2000 and 2015 were collected from a court database in South Korea. Factors that influenced the effectiveness of settlement agreements were analyzed. RESULTS: Among the 287 court precedents, there were 68 cases of covenant not to sue. Eighteen cases were dismissed because the settlement agreements were recognized as effective, and 50 cases were sent forward for judgment on their merits because the agreements were not recognized as effective. The types of surgery and types of complications were classified by frequency. We evaluated the geographical distribution of the precedents, the settlement timing, and the effectiveness and economic impact of the settlements. We found that there was no statistically significant relationship among these factors. Four major factors that made a settlement agreement legally effective were identified, and the data showed that fee-free reoperations were not considered by the court in determining the compensation amount. CONCLUSIONS: When preparing a settlement agreement, it is advisable to review the contents of the agreement rather than to take the preparation of a settlement agreement per se to be legally meaningful.

Legal issues related to postoperative pulmonary thromboembolism in Korea.

PURPOSE: Currently, development of pulmonary thromboembolism (PTE) after surgery is frequently being followed by legal action in Korea, as consequences may be fatal. In the current study, we assessed possible countermeasures that medical teams can take when faced with conflicting opinions on responsibility for PTE. METHODS: A retrospective analysis of claims handled by the Supreme Court and subordinate courts, from 1999 to 2015, was performed. We analyzed the type of procedure, associated complications, and critical legal points from the recorded judgments along with any liability limitations on surgeons. RESULTS: After reviewing cases between 1999 and 2015, a total of 18 cases were analyzed. There were no cases in which the surgeon was held accountable between 1999 and 2002. From 2003, there were instances of the surgeon being held accountable, with a peak of cases in 2013. Legal standards applied in judicial decision-making related to appropriate use of preventive measures, operation characteristics, doctor's reaction towards symptom occurrence, obligation of postoperative medical care, and duty of explanation. CONCLUSION: The courts in Korea have changed their position from one of denying doctors' liability to one of enforcing responsibility for PTE. Surgeons are therefore being held responsible with greater frequency, depending on the details of the case. Lessons can be learnt from precedents that can be incorporated into medical education and training programs with the aim of reducing both major PTE complication rates and litigation costs.

Analysis of Malpractice Claims Associated with Surgical Site Infection in the Field of Plastic Surgery.

Postoperative infections are rare after plastic surgery; however, when present, they can affect the aesthetic outcome. Currently, many malpractice lawsuits are associated with surgical site infection. The present study aimed to analyze malpractice claims associated with surgical site infection in the field of plastic surgery through a review of Korean precedents. We analyzed the type of procedure, associated complications, and legal judgment in these cases. Most claimants were women, and claims were most often related to breast surgery. The common complications related to surgical site infection were deformity, scar, and asymmetry. Among the 40 cases, 34 were won by the plaintiff, and the mean claim settlement was 2,832,654 KRW (USD 2,636.6). The reasons for these judgements were as follows: 1) immediate bacterial culture tests were not performed and appropriate antibiotics were not used; 2) patients were not transferred to a high-level hospital or the infection control department was not consulted; 3) surgical site infection control measures were not appropriate; and 4) surgical procedures were performed without preoperative explanation about surgical site infection. The number of claims owing to surgical site infection after surgery is increasing. Infection handling was one of the key factors that influenced the judgement, and preoperative explanation about the possibility of infection is important. The findings will help surgeons achieve high patient satisfaction and reduce liability concerns.

Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents.

BACKGROUND: In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. METHODS: We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. RESULTS: Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. CONCLUSIONS: Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers.

Effects of neodymium-yttrium-aluminum garnet (Nd:YAG) pulsed high-intensity laser therapy on full thickness wound healing in an experimental animal model.

OBJECTIVE: Wound healing can be aided by the use of low- and medium-intensity lasers. The use of pulsed neodymium-doped yttrium aluminum garnet (Nd:YAG) high-intensity laser therapy (HILT) with a 1064-nm wavelength laser provides deeper and more efficient penetration into tissue as it is being less absorbed by chromophores in tissue, e.g., hemoglobin, melanin, and water, thereby enhancing the wound-healing process. In this study, we examined the effect of HILT on wound healing with a Q-switched pulsed Nd:YAG laser in an animal model. DESIGN: Sixty SKH1 hairless male mice (seven weeks old) were randomly divided into four groups according to the amount of laser fluence: control, group 1 (0.8 J/cm2), group 2 (1.6 J/cm2), and group 3 (2.0 J/cm2). Laser treatment was provided to groups 1, 2, and 3 with a 1064-nm Q-switched Nd:YAG laser. Histological analysis was performed with hematoxylin and eosin staining, Masson's Trichrome staining, and Ki-67 staining. RESULTS: Statistically significant increases in the accumulation of collagen fibers, thickness of granulation tissue, and numbers of fibroblasts were observed in group 2 (treated with 1.6 J/cm2) as compared with the control (no laser treatment), group 1 (treated with 0.8 J/cm2), and group 3 (treated with 2.0 J/cm2). CONCLUSION: Nd:YAG HILT stimulated fibroblast proliferation and increased extracellular matrix production. We expect that this therapy could accelerate the wound-healing process.

A Legal Analysis of the Precedents of Medical Disputes in the Cosmetic Surgery Field.

BACKGROUND: Disputes regarding medical malpractice occur between practitioners and patients. As patients have become increasingly aware regarding medical care, an increase in the unexpected side effects of procedures has been observed, thereby leading to an increase in disputes regarding medical malpractice. In this study, we reviewed trends in precedents involving cosmetic surgery-related medical disputes, with the goal of helping to prevent unnecessary disputes in the future. METHODS: We conducted a search of the judgments made in South Korean courts between 2000 and 2013 that were related to the field of plastic surgery. A total of 54 judgments were analyzed, and the selected precedents were reviewed and classified according to the kind of negligence involved. RESULTS: The claim amounts ranged from under 8 million KRW (6,991 USD) to 750 million KRW (629,995 USD). The most common ratio of the judgment amount to the claim amount was 20%-30%. The judgments were classified according to the following categories: violation of the duty of explanation in 17 cases (29%), violation of the duty of care in 10 cases (17%), violation of both duties in 20 cases (35%), and no violation of duty in six cases (10%). CONCLUSIONS: Cosmetic surgery-related suits require different approaches than general malpractice suits. The Supreme Court requires plastic surgeons to determine the type, timing, methods, and scope of their treatments when considering possible results. Therefore, practitioners should be educated on their rights and responsibilities to enable them to cope with any possible medical dispute that may arise.

The Effect of Botulinum Toxin on an Iatrogenic Sialo-Cutaneous Fistula.

A sialo-cutaneous fistula is a communication between the skin and a salivary gland or duct discharging saliva. Trauma and iatrogenic complications are the most common causes of this condition. Treatments include aspiration, compression, and the administration of systemic anticholinergics; however, their effects are transient and unsatisfactory in most cases. We had a case of a patient who developed an iatrogenic sialo-cutaneous fistula after wide excision of squamous cell carcinoma in the parotid region that was not treated with conventional management, but instead completely resolved with the injection of botulinum toxin. Based on our experience, we recommend the injection of botulinum toxin into the salivary glands, especially the parotid gland, as a conservative treatment option for sialo-cutaneous fistula.

The Legal Doctrine on 'Limitation of Liability' in the Precedent Analysis on Plastic Surgery Medical Malpractice Lawsuits.

This study intended to review the precedents on plastic surgery medical malpractice lawsuits in lower-court trials, classify the reasons of 'limitation of liability' by type, and suggest a standard in the acknowledgement of limitation of liability ratio. The 30 lower-court's rulings on the cases bearing the medical negligence of the defendants acknowledged the liability ratio of the defendants between 30% and 100%. Ten cases ruled that the defendants were wholly responsible for the negligence or malpractice, while 20 cases acknowledged the limitation of liability principle. In the determination of damage compensation amount, the court considered the cause of the victim side, which contributed in the occurrence of the damage. The court also believed that it is against the idea of fairness to have the assailant pay the whole compensation, even there is no victim-side cause such as previous illness or physical constitution of the patient, and applies the legal doctrine on limitation of liability, which is an independent damage compensation adjustment system. Most of the rulings also limited the ratio of responsibility to certain extent. When considering that the legal doctrine on limitation of liability which supports concrete validity for the fair sharing of damage, the tangible classification of causes of limitation of liability suggested in this study would be a useful tool in forecasting the ruling of a plastic surgery medical malpractice lawsuit.

Unusual Bilateral Impalement Injury with Rusted Iron Bars on Face and Neck.

Impalement injury is the subset of penetrating trauma, defined as fixed, elongated objects penetrate and remain in the human body cavity or region by relatively low velocity. We report an unusual case of facial and neck impalement where two dirty rusted iron bars penetrated forehead bilaterally and exited neck and ear respectively without causing major organ injuries. After thorough radiologic and physical evaluation, the patient got medical and surgical treatment. The patient was discharged without complication after four day of delayed wound closure. There have been no complications and sequelaes related with trauma, wound infection and scar contracture at 3-year follow-up. According to affected organs and pattern of impalement, individualized and multidisciplinary surgical approach should be considered. Following these guidelines as in this case, it was possible to achieve excellent clinical outcome in impalement injury.