Subcutaneous implant breast reconstruction: Time to reconsider?

Improvements in breast surgery techniques such as skin and nipple preserving mastectomy and innovative prosthetics (implants, acellular dermal matrices and meshes) is renewing interest in subcutaneous (pre-pectoral) implant reconstruction. The aim of this paper is to review the current literature in an attempt to provide a rationale that may support a return to subcutaneous implant placement, so minimising the pain and functional problems resulting from submuscular breast reconstruction.

Improving postoperative pain management in subpectoral tissue expander implant reconstruction of the breast using an elastomeric pump.

INTRODUCTION: Postoperative pain after breast surgery is one of the major factors contributing to delay in mobilisation and prolonged hospital stay. A retrospective analysis was performed of patients undergoing skin sparing mastectomy and insertion of a subpectoral implant. The aim was to determine whether the use of an elastomeric local anaesthetic pump improved pain control and length of stay. METHODS: Twenty-five consecutive patients undergoing the above procedure were sited with an elastomeric local anaesthetic infusion pump intraoperatively, in addition to standard regular and pro re nata analgesia. The control group comprised 25 patients undergoing the same procedure in the same year who received standard analgesia alone. Visual analogue scale scores were recorded for the duration of inpatient stay, as was any further analgesic requirement. RESULTS: The median age was 51 years (range: 26-75 years) in the intervention group and 50 years (range: 28-70 years) in the control group. The mean visual analogue scale score was 0.28 (standard deviation [SD]: 0.61) at 24 hours for the intervention group and 1.84 (SD: 0.37) for the control group (p<0.0001). The mean length of stay was 1.8 days (SD: 0.71 days) for the intervention group and 2.28 days (SD: 0.94 days) for the control group (p=0.15). There were no complications involving catheter placement, leakage or toxicity relating to use of the local anaesthetic. CONCLUSIONS: There was significantly reduced pain with the use of the local anaesthetic infusion pump. The elastomeric pump is a step towards enhanced patient recovery after breast surgery in the case of skin sparing mastectomy and subpectoral tissue expander reconstruction.

Interferon gamma release assay in the diagnosis of tuberculous mastitis.

Tuberculous mastitis is rare, especially in Western countries. We describe a case where the interferon gamma release assay blood test led to diagnosis and successful treatment of the disease.

Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study.

INTRODUCTION: Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction, but recent evidence suggests complication rates may be higher when ADM is used. We retrospectively compared early complications and implant loss in implant-based breast reconstruction (BR) with and without ADM to evaluate the safety of the procedure in our centre. METHODS: Case-notes of consecutive women undergoing implant-based BR from May 2011 to November 2012 were retrospectively reviewed. Data were extracted using a standardised pro-forma and the rate of early complications, major complications and implant loss compared between procedure groups. RESULTS: Forty-six implant-based reconstructions were performed for malignancy (n = 31, 67.4%) or prophylaxis (n = 15, 32.6%) in 31 women over the 18-month study period. ADM (Tecnoss Protexa(®), Tecnoss S.r.l.) was used in 31 (67.4%) cases. There were no differences in patient age, BMI, co-morbidities, smoking or chemotherapy between groups, but patients receiving ADM were more likely to have received radiotherapy prior to their reconstruction (n = 6, 30% vs. n = 0, 0%, p = 0.043). The overall rate of early complications was 26.1% (n = 12) but there was no significant difference between procedure groups (standard-n = 4, 27.7% vs. ADM-n = 8, 25.8%; p = 0.950). There were 2 (4.3%) major complications none of which were associated with ADM use (standard-n = 2, 13.3% vs. ADM-n = 0, 0.0%; p = 0.038). There were 6 (13.0%) implant losses of which 4 were in the ADM group (standard-n = 2, 13.3% vs. ADM-n = 4, 12.9%; p = 0.968). All of these were associated with pre-reconstruction radiotherapy. CONCLUSIONS: ADM-assisted implant-based reconstruction with Tecnoss Protexa(®) is safe and may improve outcomes for women by facilitating a single-stage procedure. Robust prospective evaluation is now needed to definitively evaluate the role of ADM in implant-based BR.

Why should breast surgeons use ultrasound?

Portable ultrasound is now used in a variety of clinical settings by specialties outside of radiology. Despite increased accessibility to ultrasound, the overall performance of ultrasound by breast surgeons is consistently low. We discuss the reasons why this is unacceptable for future patient care and answer the question, 'Why should breast surgeons use ultrasound?' We reviewed the literature for evidence assessing the outcomes of breast surgeon-performed ultrasound both intra-operatively and in the outpatient department. Intra-operative ultrasound performed by surgeons reduces re-excision rates in breast-conserving surgery. Outpatient-based ultrasound performed by surgeons frees up the resources of radiology departments, allowing them to focus upon patients requiring more complex diagnostic and interventional procedures. For surgeons to competently perform intra-operative and outpatient-based ultrasound, a period of formal ultrasound training is necessary to acquire knowledge of ultrasound skills and techniques. This should be followed by a period of mentorship and supervised training with an experienced breast radiologist. Breast surgeon-performed ultrasound is beneficial to the multi-disciplinary care of breast cancer patients. To further improve multidisciplinary care, breast surgeons and radiologists should work more collaboratively to optimise imaging applications both in the operating theatre and outpatient department. Current advances in therapeutic percutaneous techniques are of interest to both surgeons and radiologists. In future, a hybrid specialisation should be considered to incorporate accreditation in both specialties for breast interventional procedures.

Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study.

BACKGROUND: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after mastectomy for breast cancer but currently, few women opt for surgery. Reasons for this are unclear. The aim of this qualitative study was to explore access to care and the provision of procedure choice to women seeking reconstructive surgery. METHODS: Semi-structured interviews with a purposive sample of patients who had undergone BR and professionals providing specialist care explored participants' experiences of information provision before BR. Interviews were transcribed verbatim and analysed using the constant comparative technique of grounded theory. Sampling, data collection and analysis were performed concurrently and iteratively until data saturation was achieved. RESULTS: Both patients and professionals expressed concerns about the provision of adequate procedure choice and access to care. Lack of information and/or time, involvement in decision making and issues relating to the evolution and organisation of reconstructive services, emerged as potential explanations for the inequalities seen. Interventions to improve cross-speciality collaboration were proposed to address these issues. CONCLUSION: Inequalities in the provision of choice in BR exist, which may be explained by a lack of integration between surgical specialities. Pathway restructuring, service reorganisation and standardisation of training may enhance cross-speciality collaboration and improve the patient experience.

The association of waiting times from diagnosis to surgery with survival in women with localised breast cancer in England.

BACKGROUND: Survival from breast cancer in the United Kingdom is lower than in other developed countries. It is unclear to what extent waiting times for curative surgery affect survival. METHODS: Using national databases for England (cancer registries, Hospital Episode Statistics and Office of National Statistics), we identified 53 689 women with localised breast cancer, aged ≥ 15 years, diagnosed between 1996 and 2009, who had surgical resection with curative intent within 62 days of diagnosis. We used relative survival and excess risk modelling to determine associations between waiting times and 5-year survival. RESULTS: The median diagnosis to curative surgery waiting time among breast cancer patients was 22 days (interquartile range (IQR): 15-30). Relative survival was similar among women waiting between 25 and 38 days (RS: 93.5%; 95% CI: 92.8-94.2%), <25 days (RS: 93.0%; 95% CI: 92.5-93.4%) and between 39 and 62 days (RS: 92.1%; 95% CI: 90.8-93.4%). There was little evidence of an increase in excess mortality with longer waiting times (excess hazard ratio (EHR): 1.06; 95% CI: 0.88-1.27 comparing waiting times 39-62 with 25-38 days). Excess mortality was associated with age (EHR 65-74 vs 15-44 year olds: 1.23; 95% CI: 1.07-1.41) and deprivation (EHR most vs least deprived: 1.28; 95% CI: 1.09-1.49), but waiting times did not explain these differences. CONCLUSION: Within 62 days of diagnosis, decreasing waiting times from diagnosis to surgery had little impact on survival from localised breast cancer.

Sentinel lymph node biopsy following prior augmentation mammaplasty and implant rupture.

We report the case of a 44 year old lady with bilateral cosmetic silicone breast implants who had previously undergone a change of her right implant following extracapsular rupture. She presented 4 years later with a new lump in her right breast and underwent subcutaneous mastectomy for a grade 3 invasive ductal carcinoma. Sentinel lymph node biopsy demonstrated axillary silicone lymphadenopathy but nil evidence of metastatic disease. We present this as the first described case of successful sentinel lymph node biopsy in the context of prior augmentation mammaplasty and ipsilateral implant rupture with silicone lymphadenopathy.

Gynaecomastia: a decade of experience.

BACKGROUND: Gynaecomastia is the most common benign condition of the male breast and accounts for up to 80% of male breast referrals. We sought to identify any changes in the number of patients referred with the condition and assess its impact on clinical practice. METHODS: Patients were identified from two prospectively maintained databases. Diagnosis of gynaecomastia was based on clinical findings, ultrasound scan (USS) assessment and/or histology. RESULTS: There was a significant increase in the number of men referred to a specialist unit and diagnosed with gynaecomastia. Gynaecomastia was more prevalent in the under twenties age group. Core biopsy (CB) became the histological investigation of choice for men with unilateral disease and there was no change in the percentage of men undergoing surgery. CONCLUSION: Most men are looking for reassurance that their condition is benign and that no intervention is required. Thus it is important to offer these men psychological support as part of their treatment.

Reporting clinical outcomes of breast reconstruction: a systematic review.

BACKGROUND: Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. METHODS: We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. RESULTS: Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. CONCLUSIONS: The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

Does limiting long-term follow-up for breast cancer allow all referrals to be seen in 2 weeks?

INTRODUCTION: The UK National Institute for Health and Clinical Excellence (NICE) recommends that breast cancer follow-up should be limited to 2-3 years stating this will 'release resources' making it 'possible for all women with breast symptoms to be seen within 2 weeks'. In 2000, breast cancer follow-up services in North Bristol were redesigned to reflect evidence-based best practice. The aim of this paper is to assess the impact of this policy on numbers of follow-ups, clinic capacity and waiting times. PATIENTS AND METHODS: Data regarding the numbers of new and follow-up patients seen in breast clinic between January 2000 and December 2005 were collected from the hospital Patient Administration System. New patients were categorised as either 'routine' or 'urgent' according to '2-week wait' rule guidelines. Median waiting times were calculated for each group and nominal appointment times assigned in an attempt to assess the effect of any changes on clinic capacity. RESULTS: The number of follow-ups decreased by 33% as a result of the new policy. Numbers of referrals over the same period, however, increased by 14%. Routine referrals declined, but there was a 27% increase in '2-week wait' patients. Waiting times for routine appointments initially decreased in response to reduced follow-up, but then rose as the number of '2-week wait' referrals increased. CONCLUSIONS: Reducing long-term follow-up is a simple and effective method of increasing clinic capacity but its effects are inadequate and transient in the face of increasing service demand. Additional innovative and creative strategies will be required if all breast patients are to be seen within 2 weeks.

Accuracy of sonographic localisation and specimen ultrasound performed by surgeons in impalpable screen-detected breast lesions.

The National Breast Screening Programme had dramatically impacted surgical practice. Up to 50% of all newly diagnosed cancers are now impalpable creating increased demand for image-guided localisation. Wire-guided localisation (WGL) is the current gold standard, but USS-guided localisation by radiologists is a well-documented and effective technique. Increasing numbers of surgeons are proficient in using ultrasound and may be as accurate as radiologists in localising lesions intra-operatively. Of 68 patients with screen-detected impalpable lesions referred to one surgeon in our unit between January 2005 and February 2006, 32 had mass lesions, which were well seen on ultrasound and underwent intra-operative USS-guided localisation performed by a surgeon. All lesions were correctly identified and 87.5% (n=28) were fully excised. Those lesions not fully excised were lobular cancers. Intra-operative sonographic localisation performed by surgeons is an accurate and effective technique. It may produce less patient anxiety and discomfort than WGL and allow more effective and efficient use of resources and theatre time.

Patient satisfaction and time-saving implications of a nurse-led nipple and areola reconstitution service following breast reconstruction.

Nipple tattooing is a safe and effective technique for restoration of the nipple-areola complex following breast reconstruction and has a positive impact on patient well-being and body image. This procedure is usually performed by a surgeon, but following appropriate training, a nurse-led nipple tattooing service was established in our unit in December 2005. All 14 patients who had undergone nipple tattooing over a 6 month period were contacted by telephone and questioned about their cosmetic results and satisfaction with the service. Hundred percent of patients were 'satisfied' with their tattoo and all patients rated the nurse-led service as 'excellent'. It was estimated that 20h of consultant time was saved. Our study demonstrates that a nurse-led service is associated with both excellent cosmetic outcomes and high levels of patient satisfaction. It also results in a significant saving of consultant time allowing more effective use of clinic and theatre resources.

Sonographically guided mammotome excision of ducts in the diagnosis and management of single duct nipple discharge.

AIM: To describe our experience in the use of ultrasound guided mammotome in the diagnosis and management of single duct nipple discharge. METHODS: Patients for whom surgical excision of the single duct had been advised for single duct nipple discharge were offered ultrasound guided mammotome excision of the duct as an alternative to surgical excision. The procedure was performed in the breast clinic by a surgeon or a breast clinician who had interventional ultrasound skills. RESULTS: Seventy-seven patients had 81 procedures. Follow-up at a mean time of 16 months revealed resolution of the presenting problematic discharge in 95% of patients. Nipple discharge recurred in four patients. Two patients had microdochectomy and two had a repeat mammotome for recurrence of symptoms. Complications were mild and infrequent. CONCLUSION: Ultrasound guided mammotome excision is a new tool in the work up and management of single duct nipple discharge. It can be performed under local anaesthetic by a surgeon/breast clinician or radiologist with interventional ultrasound skills. It has the potential to replace surgical excision (microdochectomy) as a treatment for nipple discharge.

Preoperative mammotome biopsy of ducts beneath the nipple areola complex.

AIM: To evaluate the role of ultrasound guided mammotome biopsy of the ducts beneath the nipple areola complex (NAC), as a new technique in detecting the occult involvement of the NAC in breast cancer patients prior to nipple preserving subcutaneous mastectomy. METHOD: A prospective study where 33 women requesting nipple preserving mastectomy for invasive or in situ disease were offered the procedure to determine if leaving the nipple was safe. A 5 mm skin incision was made after infiltration with local anaesthetic and the 11G mammotome needle was positioned beneath the nipple under ultrasound guidance which was turned through 360 degrees as the biopsies were taken. The procedures were performed by trained non-radiologists. RESULTS: Thirty-three women had 36 procedures. Seven out of the 36 had a positive mammotome biopsy. Twenty-three patients had 26 NAC preserving mastectomies with immediate reconstruction. Three had bilateral procedures. Ten patients had NAC sacrificed. The histopathology of the mastectomy specimen correlated 100% with the mammotome biopsy. CONCLUSION: Preoperative ultrasound guided mammotome biopsy of the ducts beneath the NAC is a safe, reliable and accurate technique and is evolving as an oncologically safe procedure. The large mammotome needle can be visualized easily under high resolution, near field high frequency scanners and this increases the accuracy of the biopsy. It can replace the traditional frozen section and be used as an alternate. It can be performed safely by an appropriately trained non-radiologist (surgeon/breast clinician).

Expression of prolactin receptor mRNA in oestrogen receptor positive breast cancers pre- and post-tamoxifen therapy.

AIM: Previous in vitro studies have shown that tamoxifen down-regulates prolactin receptors in breast cancer cells. The aim of this study was to determine whether similar changes might provide the basis for a predictive test in patients. METHODS: Biopsy specimens were obtained from 28 post-menopausal women immediately before initiation of treatment with tamoxifen (20 mg daily) and after treatment for 7 days. Prolactin receptor mRNA, determined by reverse-transcription polymerase chain reaction, was then expressed relative to 18S ribosomal RNA. RESULTS: There was good evidence for a decline in receptor expression in response to treatment with tamoxifen in the whole group (p = 0.036) but with a particularly marked decrease (>60%) in a sub-group of 11 patients. No clear correlation with tumour type or grade, or with several other markers (progesterone receptor, c-erb B-2, pS2, or Bcl-2) was apparent. CONCLUSION: Tamoxifen reduces expression of mRNA encoding the prolactin receptor in a sub-group of breast tumours and might provide the basis for a predictive test for tamoxifen therapy.

First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial.

BACKGROUND: Three clinical trials on the use of tamoxifen to prevent breast cancer have reported mixed results. The overall evidence supports a reduction in the risk of breast cancer, but whether this benefit outweighs the risks and side-effects associated with tamoxifen is unclear. METHODS: We undertook a double-blind placebo-controlled randomised trial of tamoxifen, 20 mg/day for 5 years, in 7152 women aged 35-70 years, who were at increased risk of breast cancer. The primary outcome measure was the frequency of breast cancer (including ductal carcinoma in situ). Analyses were by intention to treat after exclusion of 13 women found to have breast cancer at baseline mammography. FINDINGS: After median follow-up of 50 months (IQR 32-67), 69 breast cancers had been diagnosed in 3578 women in the tamoxifen group and 101 in 3566 in the placebo group (risk reduction 32% [95% CI 8-50]; p=0.013). Age, degree of risk, and use of hormone-replacement therapy did not affect the reduction. Endometrial cancer was non-significantly increased (11 vs 5; p=0.2) and thromboembolic events were significantly increased with tamoxifen (43 vs 17; odds ratio 2.5 [1.5-4.4], p=0.001), particularly after surgery. There was a significant excess of deaths from all causes in the tamoxifen group (25 vs 11, p=0.028). INTERPRETATION: Prophylactic tamoxifen reduces the risk of breast cancer by about a third. Temporary cessation of tamoxifen should be considered and the use of appropriate antithrombotic measures is recommended during and after major surgery or periods of immobilisation. Prophylactic use of tamoxifen is contraindicated in women at high risk of thromboembolic disease. The combined evidence indicates that mortality from non-breast-cancer causes is not increased by tamoxifen. The overall risk to benefit ratio for the use of tamoxifen in prevention is still unclear, and continued follow-up of the current trials is essential.

Knowledge of cancer symptoms among patients attending one-stop breast and rectal bleeding clinics.

AIM AND METHOD: The aim of this questionnaire study was to identify knowledge of breast and colorectal cancer symptoms among 100 patients attending one-stop breast clinics and rectal bleeding clinics and to determine the source of the information. RESULTS: Seventy-five breast clinic (mean age 46 years, all female) and 78 colorectal clinic patients (mean age 59 years, 51% male) responded. Knowledge of breast was significantly greater than bowel cancer in both groups (P<0.0001, McNemar's chi(2)). There was no difference in knowledge of symptoms of breast cancer or bowel cancer between patients attending either clinic. There was a positive association between cancer knowledge, family history and female gender but no association with age. Knowledge of Bowel Cancer Awareness Week was positively associated with colorectal cancer knowledge. CONCLUSION: Knowledge of colorectal cancer is much less than breast cancer in clinic attenders. Seventy-five per cent of women attending breast clinic could name a breast cancer symptom whereas only 37% of patients attending colorectal clinic could name a bowel cancer symptom. These findings have implications when considering patients' anxiety, expectations of a cancer diagnosis and breaking bad news.

A prospective audit of the use of a buttress suture to reduce seroma formation following axillary node dissection without drains.

A prospective audit of seroma formation following breast-conserving surgery for carcinoma with axillary dissection was carried out. Ninety-seven consecutive patients were studied. The post-operative formation of fluid within the axilla (seroma) was recorded on a computerised data collection system. From August 1998 to December 1998, no drain or other axillary restriction was used. The seroma rate in 27 of these patients who had at least seven nodes in the axillary sample was 14/27 (52%). From December 1998 to June 1999, an additional suture was inserted between the axillary skin and the chest wall (buttress suture). This was designed to obliterate the axillary space after dissection. There were 37 patients with seven or more nodes in the axillary dissection in this study and of these, nine patients developed a seroma (24%) (P=0.007). The use of the buttress suture reduces the seroma rate following axillary dissection without axillary drainage.