Autogenous Tissue Breast Reconstruction in the Silicone-Intolerant Patient

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1 440 Autogenous Tissue Breast Reconstruction in the Silicone-Intolerant Patient Lu-Jean Feng, M.D.,* Kate Mauceri, R.N.,* and Bruce E. Berger, M.D.t Background. Concerns regarding the safety of silicone gel breast implants have motivated many patients with complications from their silicone breast implants to search for alternatives for breast reconstruction. Although autogenous tissue has been used for primary breast reconstruction after mastectomy, few studies have described its use in the patient in whom silicone-implant breast reconstruction has failed. Methods. Between 1988 and 1993, 33 patients who had previous unsuccessful breast reconstruction with silicone breast implants underwent implant removal and autogenous tissue reconstruction. Preoperative evaluation included implant-related problems, such as capsular contracture, pain, and loss of implant shell integrity. Systemic symptoms that developed after implantation also were evaluated. Three types of myocutaneous flaps were used for breast reconstruction: the latissimus dorsi pedicle flap, the transverse rectus abdominis free flap, and the superior gluteus maximus free flap. Follow-up evaluation was done for both implant-related problems and issues related to patient satisfaction after autogenous tissue reconstruction. Results. The overall flap survival rate for 33 women who underwent flap reconstruction was 94%. All flap losses occurred in the first nine flaps. Ninety-two percent of patients felt their autogenous tissue reconstructions were aesthetically superior to their previous implant reconstruction. All but one patient felt complete resolution in their chest wall discomfort and pain. Eighty-one percent of patients with systemic symptoms also felt improvement in their systemic symptoms. Conclusions. Autogenous tissue reconstruction from multiple areas of the body is an effective and aesthetically superior alternative for the patient who no longer desires the silicone implant option. Cancer 1994; 74: Presented at the National Conference on Breast Cancer, Boston, Massachusetts, August 26-28, From the *Division of Plastic Surgery and the tdepartment of Medicine, The Mount Sinai Medical Center, Case Western Reserve University, Cleveland, Ohio. Address for reprints: Lu-Jean Feng, M.D., Division of Plastic Surgery, Mount Sinai Medical Center, One Mount Sinai Drive, Cleveland, OH Accepted for publication January 31, Key words: silicone, surgery, plastic, surgical flaps, breast, mastectomy. Recent public attention on the possible health hazards of the silicone gel breast implants has brought forth many patients with concerns over their implants to their plastic surgeons. Although the complications of silicone gel breast implants have been documented well in the plastic surgery literature, ',' most have concentrated on complications such as capsular contracture, implant infection, and extrusion. Long-term complications, such as recurrent capsular contracture to multiple types of implants, as well as development of connective tissue disease-like symptoms that may be associated with silicone implants, have yet to be addressed. Media accounts of the various symptoms that women with breast implants develop have motivated many patients with implants and similar symptoms to question whether their implants can be the cause of their various ailments. Uncertainty over the safety of breast implants and the discovery that implants can rupture and leak over time have stirred many patients to look to the use of autogenous tissue for breast reconstruction. Although autogenous tissue from the abd~men,~ back,4 b~ttock,~ and thigh6 has been used for immediate and delayed breast reconstruction in the patient who has undergone a mastectomy, few studies have described its use in the patient who has had multiple complications with silicone and who no longer desires the silicone implant. This paper describes the preoperative evaluation and results of 33 patients who, because of multiple complications from their silicone gel implants, underwent removal of their implants and scar capsules, and reconstruction of their mastectomy deformity with autogenous tissue. Materials and Methods Pa tien t Population Thirty-three patients were seen from 1988 through August 1993 by the plastic surgeon (L.J.F.) for problems

2 Autogenous Tissue Breast Reconstruction/Feng et al. 441 related to their implants. The mean age of patients was 47 years, with a range of years. Seventeen (52%) patients underwent subcutaneous mastectomy and implant reconstruction for prophylaxis against breast cancer, 14 (42%) patients underwent modified radical mastectomy and implant reconstruction for treatment of breast cancer, 1 (3%) had implant reconstruction for congenital hypoplasia of the breast caused by Poland s syndrome, and 1 (3%) had implant reconstruction for severe deformity of the breasts after several large breast biopsies. None of the initial implant reconstructions were done by the author. The average duration from the time of initial implantation to explantation was 8.3 years, with a range of 1-19 years. Evaluation of Implant Problems Three main types of problems were found to be associated with implants. The first was capsular contracture, which was considered present when the implant felt hard to palpation. Any pain or discomfort in the chest wall was noted. Any previous replacements of implants were also recorded. The second type was implant integrity, which was assessed preoperatively by xeromammography and examined intraoperatively after the implant and scar capsule had been removed from the operative field. After the scar capsule was removed, the implant was examined under loupe magnification to detect any small perforations in the shell. The third problem encountered was implant infection, and any previous implant infections also were noted. Evaluation of Systemic Symptoms A systemic symptom was noted when it occurred at least weekly for more than 3 months and was unrelated to another disorder. Fatigue was noted when it resulted in at least a 30% reduction of daily activity. Arthralgia and myalgia were noted when they occurred in more than two joints or muscle groups. The sicca complex was assessed by observation of dry mucous membranes and/or by history of dry eyes or dry mouth. All patients with systemic symptoms had extensive medical evaluation by either internists, rheumatologists, or other medical specialists. Technique of Implant Removal At the time of implant removal, the scar capsule was removed in addition to the implant. The capsule is a morphologically distinct band of fibrosis that surrounds breast implants. Total capsulectomy was performed through an extracapsular dissection to avoid contamination of the surgical field with implant-derived mate- rial. The 1985 Dow Corning (Midland, MI) product summary of its Silastic I1 gel implants warned that if sensitization is suspected and the response persists, removal of the prosthesis is recommended along with removal of the surrounding capsule tissue. Because many patients had systemic symptoms that might possibly have been related to their implants, and because silicone is known to be present in the scar capsule, the scar capsule was removed to minimize the amount of residual silicone left behind in patients suspected of having reacted to the silicone. Removal of the implant enclosed within the scar capsule also allowed a more accurate diagnosis of implant integrity, because the implant would be protected by the scar capsule against possible damage to the implant during the explantation procedure. Preoperative Evaluation of Operative Risks Because autogenous tissue breast reconstruction was frequently a lengthy procedure, patients with a major system disease, such as significant chronic lung disease or severe cardiovascular disease, were discouraged from undergoing the procedure. Any patient with an unstable emotional state or who was unable to accept the donor site scar also was dissuaded from undergoing the operation. Other risk factors, such as a history of smoking, obesity, diabetes, or autoimmune disease, were considered individually to determine a patient s overall risk. Timing of Tissue Reconstruction Due to the presence of systemic illness in 22 patients, most of these patients (20 of 22) elected to have the implant removal and capsulectomy performed first, before the more major breast reconstruction with autogenous tissue. The majority of these patients were either initially unsure about whether they needed to have breast reconstruction or desired some improvement in their health status before a more major surgery. All patients without systemic illness had simultaneous implant removal, capsulectomy, and autogenous-tissue breast reconstruction. Choice of Flaps for Breast Reconstruction Three types of myocutaneous flaps were used for both unilateral and bilateral breast reconstruction: the latissimus dorsi pedicle flap, the transverse rectus abdominis free flap (free TRAM), and the superior gluteus maximus free flap. Because reconstruction was done without the use of any implant, the choice of flap was dependent on whether sufficient skin and subcutaneous

3 442 CANCER Supplement July 1,1994, Volume 74, No. 1 tissue existed in the respective donor area of the midback, abdomen, or buttock to allow an aesthetically pleasing result in the breast. Because the latissimus flap was a shorter procedure with a shorter recovery time, this flap was used for patients who desired a less major procedure and who also had sufficient tissue in the mid-back region. Although the TRAM flap can be transposed to the breast either as a pedicle or free flap, the free flap was used because the blood supply to the flap is better and less rectus muscle is sacrificed with this method.8 Contraindications to the TRAM flap were previous abdominoplasty or multiple paramedian incisions. The superior gluteal free flap must be transplanted to the breast as a free flap. Major indications for this flap were patients with a thin abdomen or patients with previous abdominal surgeries that disrupted the blood supply to the TRAM flap. Both the free TRAM and pedicle latissimus flaps can be used for bilateral reconstructions in one operation; however, for the superior gluteal free flap, due to the necessity that patients lie in the lateral decubitus position, bilateral reconstructions must be done in two stages, one side at a time. Follow-up Evaluation Follow-up evaluation of both local and systemic symptoms was done with a questionnaire answered through telephone interviews by a nurse practitioner (K.M.). There was at least a 4-month follow-up time after implant removal for the evaluation of local and systemic symptoms that developed following implantation. Evaluation of issues related to patient satisfaction also was done for patients with at least 3 months of followup after successful completion of the tissue reconstruction. Issues explored included aesthetic improvement, change in body image, breast sensation, and whether the implant removal and tissue reconstruction were worthwhile endeavors. Results Implant-Related Problems Local symptoms. Preoperatively, all 33 patients had either pain or discomfort on the chest wall or breast. Twenty-seven patients (82%) had capsular contracture. Sixteen patients (48%) had more than one set of implants due to previous severe or recurrent capsular contracture. The average number of previous replacements of implants in this group of patients was two, with a range of one to eight replacements. Thirty-one patients underwent removal of implants with capsulectomy. Two other patients had their im- Table 1. Type and Frequency of Systemic Symptoms After Implantation (N = 22) Symptoms YO of patients No. of patients Fatigue Arthralgia Sensory peripheral neuropathy Neurocogni tive Sweats/chills M yalgia Shortness of breath Sicca Rash 36 8 Nausea 27 6 Lymphadenopathy 27 6 Alopecia 14 2 Ra ynaud's 14 3 Arthritis 5 1 plants removed elsewhere. Twenty-two patients (71 YO) had intact implants, and nine (29%) had ruptured implants. Of the patients with intact implants, five had a history of rupture in previous implants. Of these five patients, three had extravasated silicone gel left in the tissue adjacent to the intact implant from the previous rupture. Two patients (6%) had documented bacterial infection around their implants at the time of removal. Two others had a history of implant infection in previous implants. Of the 29 patients with at least 4 months of followup after capsulectomy and implant removal, all but one felt complete resolution of discomfort and pain in their chest wall and breast. The other patient felt improved in terms of decreased intensity and frequency of pain. Systemic symptoms. In the preoperative evaluation, 22 of 33 patients (68%) developed systemic symptoms after implantation. One patient, who had rheumatoid arthritis before implantation, was excluded from the group of patients with systemic symptoms. Ten patients had no systemic symptoms. Table 1 documents the type and frequency of systemic symptoms reported by the patients with systemic illness. Fatigue was present in all 22 patients. Over half of the patients had, in addition, arthralga (95%), sensory peripheral neuropathy (73%) in terms of numbness and tinghg in a stoclung-and-glove distribution, neurocognitive problems such as short term memory loss (73%), night sweats and chills (68%), and myalgia (64%). Fifteen patients sought rheumatologic evaluation. The other seven patients sought other medical specialists for evaluation of their symptoms. Fourteen patients were seen by the same rheumatologist in our institution. Of this group, eleven patients were diagnosed with fi-

4 ~ ~~ Autogenous Tissue Breast Reconstruction/Feng et al. 443 Table 2. Type and Frequency of Improved Systemic Symptoms in 21 Patients With More Than 4 Months Follow-up After Implant Removal and Capsulectomy Total no. of No. of patients with patients with % Patients Improved symptoms symptom improvement improved Fatigue Sensory peripheral neuropathy Rash Sweats/chills Arthralgia Sicca Neurocognitive Myalgia bromyalgia and three with chronic fatigue syndrome. There was no definitive diagnosis in the other eight patients with systemic symptoms. None of the patients who developed systemic illness after implantation had a documented autoimmune disease. Twenty-one of 22 patients with systemic symptoms had at least 4 months of follow-up after capsulectomy and implant removal. Seventeen patients (81%) felt improvement in at least two systemic symptoms. Of these 17 patients, improvement of fatigue was noted in 16 patients (76%), of sensory peripheral neuropathy in 12 patients (71%), of rash formation in 5 patients (71%), of night sweats and chills in 10 patients (67%), of arthralgia in 12 patients (60%), and of sicca symptoms in 5 patients (56%) (Table 2). Results of Autogenous Tissue Reconstruction Of the 33 patients who underwent autogenous tissue reconstruction, 7 were at least 15% above their ideal body weight. Eleven patients (33%) were smokers. Two patients had diabetes mellitus, of whom one was insulin-dependent. One patient had rheumatoid arthritis, and three patients had Raynaud's phenomenon. There were a total of 52 flaps performed on 33 patients. Thirty-two flaps were free TRAMS; of these, 10 were bilateral and 12 were unilateral. Eleven flaps were free superior gluteal flaps; of these, four were bilateral, and three were unilateral. Nine flaps were latissimus flaps; of these, four were bilateral and one was unilateral. Forty-nine of the 52 flaps were completely successful, without any partial flap losses. The overall flap survival rate was 94%. The three flap losses occurred in two patients: one patient who underwent a superior gluteal free flap reconstruction and another who underwent a bilateral free TRAM reconstruction. These three flap losses occurred before June and were in the first nine flaps. In the subsequent 43 flaps, there has been 100% flap survival. One patient who had a superior gluteal free flap reconstruction developed venous thrombosis in the microsurgical anastomosis, requiring emergent revision of the anastomosis in the first 24 hours postoperatively. This complication also occurred before June There were no donor-site complications, such as shoulder weakness from the removal of the latissimus muscle, hip weakness from removal of the superior portion of the gluteus maximus, or abdominal weakness from removal of the lower rectus muscle (as in the unilateral TRAM flap). Two patients who had bilateral free TRAM reconstruction developed lower abdominal weakness. Both of these patients required additional repair of the abdominal wall fascia with prolene mesh. At surgery, both patients were found to have suture failure as a cause for the abdominal weakness. It also is of note that both patients were obese, with one being 23% above her ideal body weights and the other being 50% above ideal weight. This suture failure in obese patients has resulted in a change of suture material to a heavier, double-stranded suture. Only one patient (3%) required transfusion from the blood bank in addition to the transfusion from donated autogenous blood (Table 3). All patients were asked to donate at least one autogenous unit (up to two) for reconstruction. Eighteen of 33 patients (55%) required no transfusion, and 14 (42%) were transfused Table 3. Need for Transfusion in 33 Patients With Autogenous Tissue Reconstruction No. of patients % of Patients Transfusion None Au tologous 1 3 Homologous

5 444 CANCER Supplement Jury 2, 2994, Volume 74, No. 1 Figure 1. A 56-year-old patient who developed painful capsular contracture, limitation of right shoulder motion, and deformity after a modified radical mastectomy, silicone gel implant reconstruction, and nipple-areolar reconstruction in with autogenous blood. The patient who was transfused with homologous blood needed the additional blood because of additional reexploration surgery for thrombosis of the venous anastomosis, as noted above. As a result of meticulous hemostasis and the use of closed suction drains, there were no complications of hematomas or seromas. There were no postoperative infections. Patient Evaluation of Autogenous Tissue Reconstruction All 25 patients with at least 3 months of postoperative follow-up completed the questionnaire designed to Figure 2. Result after the removal of ruptured implant and total capsulectomy, breast reconstruction with a right free TRAM flap, and later re-do of the nipple reconstruction with tattoo. Figure 3. Appearance of the abdomen flap harvest with preoperative markings marking the abdominal incisions and location of musculocutaneous perforators. evaluate the results of the autogenous tissue reconstruction. Twenty-three of 25 patients (92%) felt their autogenous tissue reconstruction was aesthetically better than their previous implant reconstruction. Twentytwo patients (88%) felt they had improved sexual and body image after the autogenous tissue reconstruction. Most patients with capsular contracture felt very selfconscious when engaged in close physical contact with another person. They did not feel the hard breast belonged to them. The transformation of a hard breast to a soft breast made from their own tissue allowed most patients to feel more normal with their body image. Sixteen patients (64%) are able to feel sensation in the reconstructed breast, in terms of deep pressure and light touch, usually in the medial and lateral aspects. All 25 patients felt the surgery was a worthwhile endeavor, would do it again if needed, and would recommend it to others. Figure 1 shows a patient with capsular contracture

6 Autogenous Tissue Breast Reconstruction/Feng et al. 445 Figure 7 shows the result after bilateral breast manstruction using the bilateral TRAM free flaps. Figure 6. Appearance of the breasts after implant removal and total capsulectomy, and appearance of the abdomen before flap harvest.

7 446 CANCER Supplement July 1,1994, Volume 74, No. 1 after implant removal and capsulectomy. Because she had sufficient tissue on her back, we performed reconstruction with bilateral latissimus dorsi flaps, as shown in Figure 13. Figure 14 shows her back scars. Discussion Because of current unresolved questions over the safety of silicone breast implants, more patients are looking for alternatives to the silicone implant. This paper addresses a very timely issue of the option of autogenous tissue reconstruction for the patient who has faced a number of complications from the silicone implant, and for the patient who has significant doubts about the silicone implant. Although the issue of whether the silicone implant can cause disease may not be resolved for a long time, this paper does point out two potential problems associated with the silicone implant. Figure 7. Appearance of the breasts after bilateral reconstruction with the bilateral free TRAM flaps, later deepithelialization of the flaps behind the breasts, and appearance of the abdomen after flap harvest. Figure 8 shows a patient after implant removal after bilateral breast reconstruction after subcutaneous mastectomy. She had had a history of multiple complications with her silicone gel implants, including capsular contracture, implant infection, and extrusion. As a result of these complications, she had more than eight replacements of implants. Due to her thin body habitus, she could be reconstructed only from her buttock. Figure 9 shows the result after bilateral breast reconstruction using the bilateral superior gluteal free flaps done in two stages. Figure 10 shows the donor site scar on the superior buttock, which is concealed easily in clothing. Figure 11 shows a patient who required bilateral implant reconstruction after several large breast biopsies in both breasts for fibrocystic masses. The patient developed recurrent capsular contracture, pain, and the chronic fatigue syndrome after replacement of one set of implants because of capsular contracture and rupture. Figure 12 shows the breast deformity that occurred Figure 8. A 45-year-old patient, who had received more than eight sets of implants because of complications, after bilateral silicone gel implant reconstruction subsequent to subcutaneous mastectomy. Because of her thin body habitus, the only available tissue for reconstruction was that in her buttock.

8 Autogenous Tissue Breast Reconstruction/Feng et al. 447 Figure 9. Appearance of the breasts after bilateral reconstruction with bilateral superior gluteal free flaps done in two stages, one side at a time. First, local problems such as pain, recurrent capsular contracture, and rupture of the implant exist and can be treated successfully with removal of the implant and scar capsule, as shown in the uniform improvement in local symptoms in this small group of patients. Second, it is possible that a systemic illness that resembles fibromyalgia and chronic fatigue syndrome may develop in certain patients after implantation. Nearly all the patients reported in this paper manifested these systemic symptoms for many years. The similarity in symptom presentation in patients who have developed illness after implantation has been noted also by others. Figure 11. A 48-year-old patient who developed recurrent capsular contracture with pain after receiving two sets of implants. She also developed chronic fatigue syndrome after her first implants were replaced. The improvement in various systemic symptoms noted in these patients after implant removal and capsulectomy is an important observation. Although one cannot state for certain whether this improvement is the result of silicone implant removal, we believe that the symptom complex of fatigue, arthralgia, myalgia, sensory peripheral neuropathy, rash, sweats/chills, sicca, and neurocognitive changes may be the systemic manifestation of silicone implant exposure in certain individ- Figure 10. Appearance of the buttock donor site after harvest of the superior gluteal free flaps. Figure 12. Appearance of the breasts of the patient in Figure 11 after implant removal and total capsulectomy. She was left with excess skin with minimal breast volume.

9 448 CANCER Supplement July 1,1994, Volume 74, No. 1 Figure 13. Appearance of the breasts of the patient in Figure 1 I after bilateral reconstruction with bilateral pedicled latissimus dorsi flaps that were deepithelialized. uals. This study does not address the prevalence of these symptoms in the general population of patients with silicone implants; however, it should inform physicians who care for patients with silicone implants that such an association should be considered in a patient who has a similar unresolved illness. Future studies with larger patient sample sizes and more objective criteria for diagnosis will have to be done to characterize this illness further. Autogenous tissue reconstruction, especially with the free flap, is an excellent and viable alternative for many patients. Although free flap reconstruction is technically more difficult than the use of implants, with experience, excellent results can be achieved with minimal complications. This study also demonstrates the potential advantages of the free TRAM flap over the pedicle TRAM flap. Whereas prior studies have shown patients with small vessel disease to be at possible increased risks for complications in the pedicle TRAM flap, this was not the case in our patient populatior.. Because of the more robust blood supply of the free TRAM flap, patients in this study with small vessel disease from smoking, diabetes, or autoimmune disease tolerated the procedure well and without increased complications. This study also illustrates the importance of a third alternative to the TRAM and latissimus dorsi flaps. The superior gluteal free flap offers the thin patient the option of total autogenous tissue reconstruction. In addition, this flap is an important option for the patient who has multiple scars in the abdomen, which may have disrupted the blood supply of the TRAM. Autogenous tissue reconstruction, when compared to implant reconstruction, is a permanent procedure, without future need for replacement. As shown by us and many others, the reconstruction can closely resemble a natural breast in appearance, shape, and feel. Autogenous tissue reconstruction undoubtedly will become a more desirable option for many patients with a mastectomy deformity. With proper experience with the various flaps, we believe that this procedure can be done safely with minimal complications. It is therefore an important alternative to offer to every patient desiring breast reconstruction. References Figure 14. Appearance of the back of the patient in Figure 11 after harvest of the latissimus dorsi flaps. 1. Gylbert L, Asplund 0, Jurell G. Capsular contracture after breast reconstruction with silicone-gel and saline-filled implants: a 6- year follow-up. Plast Reconstr Surg 1990; 85: Gibney J. Use of a permanent tissue expander for bkeast reconstruction. Plast Reconstr Surg 1989; 84: Hartrampf CR. The transverse abdominal island flap for breast reconstruction: a 7-year experience. CIin Plast Surg 1988; 15: McCraw JB, Papp CT. Latissimus dorsi myocutaneous flap: fleur-de-lis reconstruction. In: Hartrampf CR. Hartrampf s breast reconstruction with living tissue. New York: Raven Press, 1991: Shaw WW. Breast reconstruction by superior gluteal microvascular free flaps without silicone implants. Plast Reconstr Surg 1983; 72: Elliott LF, Beegle PH, Hartrampf CR. The lateral transverse thigh free flap: an alternative for autogenous tissue breast reconstruction. Plast Reconstr Surg 1990; 85: Baker JL, Levier RR, Spielvogel DE. Positive identification of sil-

10 Autogenous Tissue Breast Reconstruction/Feng et al. icone in human mammary capsular tissue. PIast Reconstr Surg 1982; 69: Grotting JC, Urist MM, Maddox WA, Vasconez, LO. Conventional TRAM flap versus free microsurgical TRAM flap for immediate breast reconstruction. Plnst Reconstr Surg 1989; 83: Bridges AJ, Conley C, Wang G, Bums DE, Vasey FB. A clinical and immunologic evaluation of women with silicone breast im- 449 plants and symptoms of rheumatic disease. Ann Intern Med 1993; 118~ Hartrampf CR, Bried JT. General considerations in TRAM flap surgery. In: Hartrampf CR. Hartrampf's breast reconstruction with living tissue. New York: Raven Press, 1991: Amez AM, Bajec J, Bardsley AF, Scamp T, Webster MHC. Experience with 50 free TRAM flap breast reconstructions. Plast Reconstr Surg 1991; 87:470-8.

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