Neal Handel

A long-term study of outcomes, complications, and patient satisfaction with breast implants.

Background: Breast implants have been used worldwide for more than 40 years. Despite extensive clinical experience, there is continued concern about the safety of these devices. The purpose of this study was to compare the efficacy, complication rates, frequency of reoperation, and degree of patient satisfaction with different types of implants. Methods: This is a consecutive, population-based study consisting of all patients receiving implants at a multidisciplinary breast center between 1979 and 2004 (25 years). A prospective implant database was constructed and maintained in Excel, and statistical analysis was performed using SAS 8.2. Various outcomes, including infections, hematomas, undesirable waviness, capsular contracture, deflation, rupture, reoperation, and patient satisfaction, were monitored. Results: Data were collected on 3495 implants in 1529 women. The longer implants were in place, the greater the cumulative risk of developing contracture; hematoma significantly increased the risk of contracture; smooth and textured implants had similar contracture rates; polyurethane foam–covered implants had a reduced risk of contracture persisting for at least 10 years after implantation. There was a relatively high rate of reoperation and a relatively short interval between primary surgery and reoperation; the most common indication for reoperation was capsular contracture. Implant recipients expressed a high overall level of satisfaction. Conclusions: Breast implants are associated with a significant rate of local complications and reoperation. There are marked differences in outcomes as a function of implant surface type and surgical indication. Despite relatively frequent complications and reoperations, implant recipients are largely satisfied.

The fate of breast implants : a critical analysis of complications and outcomes

Complications and outcomes were monitored following the implantation of 1655 breast implants over a 15-year period. Smooth, polyurethane, and textured implants were used in a variety of clinical settings. The time course of capsular contracture was analyzed by the Kaplan-Meier method. Regardless of implant type or indication for surgery, the probability of contracture increased with time. Polyurethane-covered implants were associated with a significant reduction in the risk of contracture for at least 7 years following implantation. Smooth and textured silicone implants had contracture rates similar to each other, and the particular type of surface texturing (Biocel versus Siltex) was of no consequence. Contracture was more common following breast reconstruction and implant replacement than after augmentation mammaplasty and was not affected by filler material or implant size. Implant position did not alter the risk of contracture after augmentation; tissue expansion did not affect the risk of contracture after breast reconstruction. Infections were unusual but most common after reconstruction and unrelated to surface texture or filler material. Skin wrinkling was more frequent with saline implants and in the presence of surface texturing. Implant rupture was rare, with an incidence of 1 per 760 implant-years. Implant-associated connective-tissue disease was noted in only one individual, an incidence of 1 per 3801 implant-years.

Reasons Why Mastectomy Patients Do Not Have Breast Reconstruction

Breast reconstruction after mastectomy is valuable, yet only a small percentage of eligible patients ever have reconstruction. Little has been done to determine why so few patients proceed with reconstructive surgery. A homogeneous population of mastectomy patients, some of whom underwent breast reconstruction while others did not, were surveyed regarding their attitudes about breast reconstruction. A total of 245 women were surveyed. One-hundred and fifty-eight (64 percent) responded, 71 of whom had been reconstructed while 87 had not. Comparison of the responses of the two groups suggests factors that play a role in determining whether the mastectomy patient will accept or decline the option of breast reconstruction. Considerations that made it less likely that a woman would pursue reconstruction included advanced age at the time of mastectomy, concern about complications from further surgery, uncertainty about outcome, and fear about the effect of reconstruction on future problems with breast cancer. Marital status, receiving chemotherapy, or knowing a patient who had a bad result from reconstruction did not affect the decision. An awareness and understanding of these factors may be helpful to physicians in counseling patients and in increasing the number of women who enjoy the benefits of breast reconstruction.

Hooked‐wire‐directed breast biopsy and overpenetrated mammography

Six hundred fifty‐three biopsies were performed for clinically occult, mammographically detected breast abnormalities. One hundred forty‐seven cancers (22.5%) were found. Eighty‐nine of those cancers (60.5%) were noninvasive. None of the in situ lesions had involved axillary lymph nodes. Of the 58 invasive cancers, only six (10.3%) had metastases to axillary nodes. Fifty‐four patients (36.7%) were treated by mastectomy while 93 patients (63.3%) were treated conservatively, 20 by biopsy only, and 73 by lumpectomy, axillary node dissection, and radiation therapy. Only four patients (0.7%) had significant complications. Cancer 59:715‐722, 1987.

Psychosocial outcomes of breast cancer therapies: lumpectomy versus mastectomy.

The psychological status of 50 patients who had been treated for breast cancer was assessed an average of 21 months after treatment. The patients were grouped according to major treatment modalities: mastectomy with breast reconstruction, mastectomy without breast reconstruction, or lumpectomy. Lumpectomy patients had a significantly more intact body image (p less than .008) and a greater sense of sexual desirability (p less than .009) than patients in the other groups. The patients did not differ on frequency of sexual relations or on emotional symptomatology. The results of this study generally validate those found in comparable studies showing that lumpectomy promotes a more intact body image but that no surgical procedure either produces or inhibits psychological symptomatology.

Breast cancer diagnosis and prognosis in women following augmentation with silicone gel-filled prostheses

62 healthy women were studied mammographically before and after augmentation mammoplasty. Postaugmentation mammograms were done using both the implant compression and implant displacement technique. The amount of visualisable tissue was measured in all films before and after augmentation. We concluded: State-of-the-art film-screen mammography is extremely difficult to obtain in most patients augmented with silicone-gel-filled prostheses. On average, there is a decrease in measurable visualised breast tissue after augmentation mammoplasty with silicone-gel-filled prostheses. The area of mammographically measurable tissue is no different whether smooth or textured implants are used. Textured implants are less likely to form an early capsular contracture and are therefore preferred. However, the cancer-causing potential of polyurethane in humans is currently unknown. Anterior breast tissue is generally seen better with displacement mammography; posterior breast tissue with compression mammography. Better films are generally obtained when the implant is in the subpectoral position rather than subglandular. The more severe the capsular contracture, the poorer the mammogram. In addition 42 previously augmented patients developed breast carcinomas an average of 8.4 years after augmentation with silicone-gel-filled implants; 95% had palpable lesions (only 60% of which could be seen on mammography), 90% had infiltrating carcinomas, 45% had metastases to axillary nodes, and 7 patients have recurred, 5 of whom have died. We concluded: Augmented women who develop breast cancer are similar, in terms of tumour size and nodal positivity, to non-augmented breast cancer patients who present with palpable masses. When compared with non-augmented women whose breast cancers are found with screening mammography, augmented patients with breast cancer present with a higher percentage of invasive lesions and involved axillary lymph nodes, resulting in a poorer prognosis. The 40% false negative rate for mammography in this series is unduly high and alarming. Augmentation mammoplasty with silicone-gel-filled implants should be discouraged in women with a high risk of developing breast cancer.

Breast conservation therapy after augmentation mammaplasty : Is it appropriate ?

&NA; Breast conservation therapy, consisting of lumpectomy, axillary node dissection, whole‐breast irradiation, and a boost to the tumor bed, is an increasingly popular option for the treatment of breast cancer. Among patients with stage I and stage II disease, breast conservation therapy yields survival rates equivalent to those for mastectomy. The cosmetic results of radiotherapy are usually good, and this approach preseryes an intact, sensate breast. Most studies on breast conservation therapy, however, have been performed in nonaugmented patients. Relatively little has been published regarding breast conservation therapy in the presence of silicone implants. Between 1981 and 1994, we treated 33 augmented patients with breast conservation therapy. Among 26 individuals for whom complete follow‐up data were available, 17 (65 percent) developed significant capsular contracture on the irradiated side. Thus far 8 patients with radiation‐induced contracture have undergone corrective surgery. In our experience, augmented breast cancer patients treated with breast conservation therapy have less satisfactory cosmetic results than nonaugmented women. In addition, mammographic follow‐up, critical for identifying local recurrence, may be impaired by the presence of an implant and capsular contracture. On the basis of these considerations, breast conservation therapy may be less than optimal in augmented cancer patients unless explantation is performed before treatment.

The Effect of Silicone Implants on the Diagnosis, Prognosis, and Treatment of Breast Cancer

Background: Because of the prevalence of breast cancer, many augmented women eventually will develop the disease. This article reviews what is known about the effect of implants on the detection, prognosis, and treatment of carcinoma of the breast. Methods: Observations were made on 4082 breast cancer patients (3953 nonaugmented and 129 augmented) treated over a 23-year time span. Findings in the two groups were compared and differences analyzed statistically. Mammograms of all women with palpable lesions were reviewed to assess mammographic sensitivity in patients with and without implants. Cosmetic outcomes in augmented patients treated with breast conservation therapy were reviewed. Results: Augmented patients presented more frequently with palpable lesions, invasive tumors, axillary nodal metastases, and false-negative mammograms. However, there was no significant difference in stage of disease, tumor size, recurrence rates, or survival between the two groups. Augmented patients treated with breast conservation therapy often experienced poor cosmetic results and frequently required reoperation. Conclusions: Despite the diminished sensitivity of mammography in women with implants, augmented and nonaugmented patients are diagnosed at a similar stage of disease and have a comparable prognosis. Implants may impair mammography but appear to facilitate tumor detection on physical examination. Magnetic resonance imaging and breast ultrasound may be useful adjuncts, but conventional mammography remains the most reliable tool for diagnosing early breast cancer in augmented patients. Breast implants do not interfere with mastectomy or breast reconstruction but may compromise the outcome of breast conservation therapy.

The effect of silicone‐gel–filled implants on mammography

Fifty‐four women who had previously undergone breast augmentation underwent film‐screen mammography using both the standard implant compression technique and, when possible, the implant displacement technique. All had preaugmentation mammography available for evaluation. The area of mammographically visualized breast tissue before and after augmentation mammoplasty was measured using a transparent grid. Patients with subglandular implants had a mean 44% decrease of measurable tissue area with compression mammography and 36% decrease with displacement mammography. Patients with submuscular implants had a mean 25% decrease in measurable tissue area with compression mammography and 15% decrease with displacement mammography. Anterior breast tissue was seen better with displacement mammography, and posterior breast tissue was seen better with compression mammography. Most patients had some degree of parenchymal scarring and lower image quality after augmentation. State‐of‐the‐art mammography was not possible in most patients whose breasts were augmented with silicone‐gel–filled implants. Cancer 68:1159–1163, 1991.

Long-term safety and efficacy of polyurethane foam-covered breast implants

BACKGROUND Polyurethane foam-covered silicone gel-filled breast implants, introduced in the 1970s, were used in more than 110,000 American women. Because of concerns about possible toxicity, they were withdrawn from the US market in 1991. These implants remain popular in many parts of the world. OBJECTIVE The goal of this study was to evaluate long-term experience with polyurethane foam-covered implants and compare outcomes and complication rates with other types of implants. METHODS This population-based study was comprised of all individuals receiving either polyurethane breast implants (n = 568) or other types of silicone gel-filled breast implants (n = 963) for augmentation, reconstruction, or secondary revision surgery between 1981 and 2004 (23 years). A prospective implant database was established and maintained in Microsoft Excel (Redmond, WA). Data were extracted from chart review and questionnaires mailed to 719 patients (response rate, 48%). Various parameters, including infections, hematomas, excessive waviness, capsular contracture, rupture, systemic side effects, reoperation rates, and patient satisfaction were monitored. Statistical analysis was performed using SAS 9.1 (SAS Institute, Cary, NC). RESULTS The incidence of capsular contracture was dramatically lower with polyurethane foam-covered implants compared to smooth or mechanically textured implants; this beneficial effect persisted at least 10 years after implantation. Aside from a transient skin rash, there was no increase in morbidity or complications associated with polyurethane implants. CONCLUSIONS Polyurethane foam-covered implants result in long-term reduction in the risk of capsular contracture and appear to have a safety profile similar to other silicone gel-filled devices.