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1 Hello. I m Melissa Crosby. I m an Associate Professor at The University of Texas MD Anderson Cancer Center in the Department of Plastic Surgery. I d like to discuss with you the Late Effects of Breast Reconstruction. On completion of this lecture, participants will be able to describe long-term sequelae of implant reconstruction; describe the long-term sequelae of autologous reconstruction; understand how adjuvant therapies may affect reconstruction long-term; determine how reconstruction may affect breast cancer recurrence. As with any surgery or where a surgical incision has been made, scarring can occur. Abnormal scarring often is the result of tension as well as patient genetics. When I find a patient that has a widened scar, we may need to revise the scar by excising the scar and re-closing it because maybe there is tension on the closure. Hypertrophic scarring means raised scars within the boundary of the original incision that was made. Again, we may want to res --- revise the scar by excising it and re-closing it under less tension. There re pressure dressings that you can place as well as silicone sheeting, massage, and scar creams. But often times, it s patients genetics that determine how they will scar, as well as technique at the time of the surgery. You can also perform steroid injections --- injections involving different steroids for decreasing the amount of scar. Keloid is a raised scar that grows beyond the boundaries of the original wound. So, your incision is not only elevated but it also goes outside of that. This is very common in darker-skinned patients. Often times, you can try to revise the scar by excising it. However, there s a high recurrence rate involved with this. Again, pressure dressings have been tried as well as silicone sheeting, massage as well as scar creams, different steroid injections as well as radiation therapy. However, this is rarely indicated and often when this is brought forward to patients, they re not too excited about having radiation therapy for a scar. However, some patients has extensive keloiding and do require radiation therapy to decrease the inflammatory response. Again, aging and weight change may affect the results from reconstruction. We know with aging that the epidermis and subcutaneous fat do thin. Our skin strength and elas - -- elasticity decrease due to decreases in the amount of connective tissue over time. And our blood vessels become more fragile. As a result, any patient that --- that has had a reconstruction may notice maybe more rippling with their implant. If they ve had an implant-based reconstruction, their breast may become more ptotic. And what I mean by that is more droopy or they may bottom out. And scars also may become more fragile over time. Also, if a patient gains weight or loses weight, they may notice changes in their reconstruction, especially those that maybe they used their own tissue. So revisional surgeries may be required. Their natural breast with an implant reconstruction may also change and there may be requirement for a symmetry procedure. Also, may be an increased risk of abdominal complications with weight gain if they ve had an abdominalbased reconstruction.

2 Looking specifically at implant reconstruction and the late effects of implant reconstruction: Some of the late --- late effects are listed here. Asymmetry, implant rippling as well as wrinkling, implant malposition, implant deflation, capsular contracture which is a scar surrounding the implant, and infection. I m going to go through each of these individually. Asymmetry: This is most common with a unilateral breast reconstruction, meaning one breast is reconstructed and the patient has their natural breast, so it s often difficult to match a natural breast over time with aging and weight changes, especially to an implanted breast. We may need to perform a symmetry procedure on the nonreconstructed breast. And again, this may involve cosmetic procedures that we perform including breast mastopexy or lifts; breast reduction, which reduces the size of the breast; or breast augmentation, which involves placing an implant to enlarge the size of a breast. Patient may request --- also, due to the differences in size, they may request surgery. Implant Rippling and Wrinkling: This is very different than an augmentation when you have the overlying breast tissue to cover the implant. So in an implant-based reconstruction we have the overlying skin and pectoralis major muscle. Over time, this does thin and some of the compliance of the implant may be transmitted through the skin. And this appears as a ripple. So, again, minimal coverage over an implant-based reconstruction; this is often seen in the upper pole of the breast because gravity will pull the majority of the implant to the lower pole of the reconstructed breast. And, therefore, the rippling will be seen on the upper pole. Sometimes, we have to overfill an implant to fill this out. Maybe use a different type of implant that has a smooth-wall rather than a textured wall. Other options include fat grafting and dermal substitutes but may add extra coverage over that implant that isn t there, with an implant-based reconstruction. Implant Malposition: This may be related to scarring around the implant or skin laxity over time. This may require revisional surgery to reposition the implant. Around each implant, there is a scar capsule so, to reposition the implant, we may need to release that capsule, or we may need to put sutures in that capsule to help position that implant in the right position. Implant Deflation and Rupture: So, saline implant rupture, the patient will know right away because the saline will be absorbed by the body. And, therefore, they will get a flattened breast. This is easily detected on physical examination. This does require replacement with a new implant. Most manufacturers report about a 1-7% over a one to three [year] period. Silicone Rupture: There re different generations of silicone implants. And the trend has been towards making more of the viscous cohesive silicone gel. Often, these ruptures are silent and may not be noticed. Patients may come to me with a notice of a change in shape or maybe some hardening of the breast. The ruptures can occur intracapsular, which means that within that scar capsule, the implant can rupture. Usually, the silicone stays within that capsule. So that makes about 80-90% of the ruptures that I see. Extracapsular means that that silicone may go outside of the scar capsule that s formed, again, very are --- rare, less common. However, in patients that have extracapsular

3 rupture, you may notice silicone in their lymph nodes on radiographs. This may be seen and help us detect that there is a rupture. Recent data over a six-year study shows that rupture rates in reconstructed patients ranges from about 4-9%, depending on each manufacturer. How do you determine if a rupture has occurred? Really, the gold standard is performing an MRI. The sensitivity and specificity are greater than 90%. There is a special linguine sign that they look for. And it allows basically radiologists to let us know that the patient does has --- have a rupture. They also may notice inverted teardrops to determine this. Capsular Contracture: Each implant that is placed, your body notices it as a foreign body. So it will form a scar around that implant. So we do have encapsulation of a breast prosthesis. At times, it can form a firm, fibrous shell. So this can be not noticeable to the patient. There are different grades of that. And, depending on the grade and the extent of scarring that forms around that implant, may cause us to perform a revisional surgery. So as you can see here, Grade IV, this is severe contracture where the patient has a very firm, visibly obvious scar capsule around that implant. It s often painful. These are more of the patients that we may move to do a revisional surgery. Some of the literature thinks that it may be related to a foreign body reaction or to an infection, or some of the bacteria got into the capsule --- or to the pocket when we were placing the implant. So, therefore, some of the studies do show that irrigating the pocket when we do place that implant with antibiotics, placing it under the muscle, is helpful in preventing significant capsular contracture. More commonly, this is found, however, in reconstructed patients. And it is reported at a rate of about 80-36% [speaker intended to say 8-36%] over a one to six-year period. Oftentimes, patients that have maybe had radiation therapy, they may see a more significant contracture. This also can be a ca --- the most common cause of revisional surgery as well for these patients. Often, treatment for this involves a capsulotomy which basically means just making a hole in this fibrous capsule, so releasing that scar around that implant. It also may involve removing that entire scar, so a capsulectomy, removing that fibrous capsule. Also, may be replacing that implant if it s not underneath the muscle. However, often and most commonly in reconstructed patients, the implants are placed under the pectoralis major muscle. Some patients have such significant scarring that we may need to use their own tissue. So we do remove the implant, may be use a latissimus dorsi flap with an implant, or use their own tissue only. There is question that if a different implant is used, meaning a different saline versus silicone, or a different kind of texturing, they felt in the past that maybe textured implants cause less contracture. However, recently, this has not been shown to be true. Infection: As any kind of foreign body, this can become infected. This is usually an early complication, four to six weeks, maybe, after surgery within, you know, postoperative period. Again late infection, really a low incidence of that, may be related to bacteremia. The patient gets an infection from another cause and it seeds the implant. We do show that there s really no indication for routine antibiotic prophylaxis so many patients come

4 to me saying, I have a dental procedure. I have an implant in. Do I need to have prophylaxis with antibiotics? There re no studies to show that this is warranted. Treatment for this is based on the suspected organism. So you want to try to identify the organism that s causing the infection and focus your antibiotic therapy on this. In severe infections, removing the implant may be required to help the patient heal from this and cure the infection. With implant reconstruction, patient satisfaction is usually significantly higher in those patients that have had silicone implants, and bilateral versus unilateral reconstruction. This is most likely due to the fact that it s very difficult again to recreate a breast that mimics a natural breast, especially in an implant-based reconstruction which is more perky-looking. Satisfaction over time is diminished with both kinds of implants. Post mastectomy radiation, again, has a significant negative effect on breast satisfaction for both types of implants, mostly related to the capsular contracture. Implant reconstruction is also assodi --- associated with higher revision rates than other types of reconstruction, opting for replacement, you know, making it more symmetric, changing that pocket, as we discussed. Looking at a latissimus dorsi breast reconstruction: Some of the late effects of this reconstruction can involve scarring, asymmetry, persistent seroma, muscle contraction, fullness under the arm along the chest, implant issues, because often the implant is placed under the latissimus dorsi flap, and shoulder biomechanical changes. And I ll go through each one of these individually. Again, as mentioned with implant reconstruction, there is scarring involved in this, and the scar is often in a different location than where the mastectomy was performed. So on the back --- so, you have both a scar on the back as well as the chest. There may be required revisions of this scar once it s healed and the skin relaxes. So there may have been tension on the closure. You get a widened scar and this may need to be revised in a secondary surgery. Also, asymmetry: As with any type of reconstruction, you can have changes with aging, weight gain, effects from the implant that s underlying it, and this may require revision or symmetry procedures. Persistent seroma: this is probably the most common early complication of a latissimus dorsi flap due to the large surface area of the back where the donor site is. So placing may require serial drainage, a drain replacement if, you know, you can t remove the fluid with just serial drainage. Also, there s been use of sclerosing agents to scar down that pocket that s in the back to assist with getting rid of that seroma. Over time, there is a bursa or scar capsule in a sense, that does form when a chronic seroma exists. And, therefore, this may require surgical removal, mattress sush --- suturing and different techniques to try to close down this cavity. Also, patients notice some fullness under the arm along the chest. Again, when we perform this flap reconstruction, the flap is rotated under the arm and that muscle underlies the arm on the side of the axilla. So most of the time, we tell patients that it will atrophy over time because they aren t using it as much as they would if they had it in its normal anatomical location. So it will atrophy over time. Also, we can perform

5 liposuction of the overlying tissue to reduce the bulk. Again, because there is an implant in place, there are implant issues as discussed prior. And, these issues may result in revisional surgeries for patients having a latissimus dorsi flap. Shoulder Biomechanical Changes: So the latissimus dorsi muscle is one of 26 muscles that make up the shoulder joint. As you can see here, it involves multiple functions including medial rotation, backward extension, adduction. It helps depress a raised arm. And it s an accessory cough and squeeze muscle for us. There are six other muscles that also act in extension, adduction, and internal and external rotation. So when a patient loses the latissimus muscle, there is a synergistic action of the teres major muscle, which leads to hypertrophy and compensation. When looking at patients that have had the latissimus dorsi muscle, there s usually improvement over about a six to 12 months. They don t loo lose any range of motion, both active and passive. It s really unchanged from most studies. We do find that patients may have a faster rate of fatigue with certain activities that use extension and adduction, so ladder-climbing, swimming, or pushing up in a chair. Again, most patients don t complain of any fatigue or any problems having this procedure. Physical therapy may be necessary, however, just to increase the strength and range of motion, and assist patients with having less fatigue in certain activities if they do those activities often. When we look at reconstructions that involve autologous tissue from the abdomen, so the TRAM flaps, the DIEP, the SIE flaps, there are effects from this surgery as well. Some late effects include scarring again, asymmetry, fat necrosis, and abdominal weakness including bulges and hernias. Scarring: So when we perform this procedure, again, an incision is made in another location in the body, so the patients have a scar both on their abdomen as well as their chest. Depending on how that scar heals, we may need to revise the scar again. At the time of surgery, there is swelling so there may be more tension on closure so later we want to revise that scar when there is less tension and swelling. Patients do mak --- complain of paresthesias, so some numbness, a belt-like sensation. So I often tell my patients that if they get bloated or they eat a full meal, they may feel like they have a belt on, giving them tightness in that area. So also issues of asymmetry once again. This is their own tissue so if they have weight gain or weigh loss, then this tissue is going to change with them. So they ll gain weight in that breast reconstruction, or may lose weight in that breast reconstruction, so the size of that breast may change. In addition, if they gain weight, they may have increased pressure intra-abdominally where that tissue was closed, so leading to increased laxity and maybe risk of hernias and bulges, or that increased feeling of tightness and that belt-like sensation. So I often tell my patients to try to maintain a constant weight so that they don t have to deal with these issues.

6 Fat Necrosis: This basically means when there is inadequate blood supply to the fat that we transfer with the flap. So you can have death of the fat as well as scarring. It s basically a sterile inflammatory process that results in saponification of the fat by both blood and tissue lipases. So what results and how would you identify fat necrosis? Basically, it s a hardened area in the reconstruction so when you palpate the reconstructed breast, you feel a hardened area. Well, of course, with patients that have had a history of breast cancer, any kind of lump or bump is very concerning. So if there is a concern, an ultrasound can be performed. And often, just with an ultrasound, you can distinguish between cancer recurrence and fat necrosis. If there s any concern, then confirmation with a biopsy may be necessary. Oftentimes, I have my patients do massage, monitoring of this area, making sure it doesn t get any larger, and then confirmation with further studies. Sometimes, I may have to excise the area if it s in an area that is disturbing to the patient or aesthetically not pleasing. I can also break this up with liposuction cannulas often times as well, to make it a softer area on the breast reconstruction. Probably, more importantly, there s a risk of abdominal weakness and this is when we talk about the trend towards preserving that abdominal muscle, that rectus muscle, when we perform abdominal tissue transfer. This is why the trend towards those perforator flaps, meaning preserving that muscle, taking just the overlying skin and fat, and not taking that muscle. The important part is, is even with remee --- leaving that muscle behind, we still go through the fascia which is the strength layer of the abdomen. So as a result, there may be laxity of that abdominal fascia which is called a bulge. So it s not really a true herniation of bowel contents. It s more an aesthetic concern, so they may notice a bulge on their abdomen. And it s related to abdominal laxity. This can really occur with any type of flap that s harvested. So even if you leave muscle behind, it could get denervated so it allows laxity of the abdomen, as well as the fascia may become lax and weak, resulting in a bulge. Patients that may have had a pedicled TRAM, so mean --- leaving it on its blood supply, may see a bulge because the muscle has been transferred. So they may see a bulge kind of near their chest region where that muscle is. So similar to the latissimus flap where they see that kind of extra fullness under their arm, you may also see a bulge in muscle on their chest, or maybe some laxity in the upper abdomen where the flap is transferred. A true hernia is more concerning, and this is where the bowel contents basically strewed through that fascia layer. Again, this is more concerning. You can distinguish between a bulge and a hernia, based on CT scan. If a patient does have a hernia, then this may need surgical treatment because there can be risk of strangulation or incarceration of the bowel contents; again, pretty rare. The abdominal weakness: Basically, we worry about this more with bilateral reconstruction because we re entering two portions of the abdomen, making two incisions through the fascia and potentially taking --- weakening the muscle on both sides. The SIEA flap, which is the superficial inferior epigastric artery flap, that flap lies about the fascia so we don t have to take any fascia muscle. So it really has the lowest risk as --- of abdominal weakness as well as hernias and bulges. The rate of abdominal wall complications ranges from about 3%-48% and depends upon the type of flap,

7 unilateral versus bilateral reconstructions. That DIEP flap, the deep inferior epigastric perforator flap, so basically leaving that muscle behind and just taking the perforator, has about one-half the risk of abdominal bulge or hernia, as compared to taking a free muscle flap, so taking that entire rectus muscle with your skin and overlying fat. It does also, however, have an increased risk of the fat necrosis that we spoke about easi --- earlier because there s not as much muscle and maybe blood supply to that overlying skin and fat. However, we did find no difference in fat necrosis between what we call a muscle-sparing flap and a DIEP flap, muscle-sparing meaning that we have left some muscle behind and, again, the perforator flap. Functional Deficits: There re been studies looking at the physiotherapy and deficits caused by taking these flaps. Obviously, with a pedicled TRAM, patients may experience more deficit on a physical therapy evaluation because of removing that rectus muscle and having decreased oblique muscle function. A free TRAM, meaning taking it off its blood supply but still taking the entire muscle, has really shown no minimal deficit in rectus muscle function. However, the perforator flaps are much better in the sense of abdominal weakness, their function return to baseline. But most patients will tell you that have gone through many of these procedures, especially in unilateral reconstructions, that subjectively they don t notice any weakness in their abdominal wall because other muscles are available to help with normal daily function. So what we found is that subjective measures of abdominal wall function are pretty similar across unilateral pedicled flaps as well as free TRAM flaps and those perforator flaps, DIEP flap procedures. Muscle-sparing flaps, compared to the DIEP in a lun --- unilateral setting, again, likely no difference in abdominal wall weakness. But again, it depends on the amount of muscle taken and the denervation of the muscle when you re performing these procedures. Patient satisfaction: When you compare all reconstructive groups including implant, latissimus dorsi and abdominal-based flaps, we do know that using the patient s own tissue has basically --- has a significantly higher general, as well as aesthetic satisfaction, than implant-based reconstructions. We also know that abdominal-based flaps had significantly higher generally and aesthetic satisfaction over latissimus dorsi flaps. However, we found no difference in satisfaction between patients receiving a pedicled TRAM and those having perforator flaps. So again, using the patient s own tissue over time probably has greater patient satisfaction. When you look at reconstruction and possible interference with adjuvant therapies, when you look at chemotherapy, studies have shows that after immediate bree breast reconstruction compared to mastectomy alone, there is an increased incidence of wound complications, however, no delay in initiation of adjuvant therapy. The incidence of overall major postoperative complications are higher in the immediate breast reconstruction group. But on multivariate analysis, there were no significant relationships determined. Immediate breast reconstruction is, again, associated with a moderate increase in time to chemotherapy. However, this was not statistically

8 significant. So the data shows that patients may extend out before they start their chemotherapy, possibly about two weeks longer if they have an immediate reconstruction, only because they are possibly at higher risk for complications. When we look at radiation therapy, both pre- and post-mastectomy radiotherapy will have effects on reconstruction regardless of the method we perform. Therefore, it s very important to determine if the patient is going to need radiation therapy. And it will help us determine what type of reconstruction we perform and the timing of the reconstruction. Implant-based reconstruction have higher rates of that pathologic capsular contracture. So when I discuss the different grades of contracture, these are the patients that we may see more of that Grade III and Grade IV, where you have a firm capsule that becomes painful that may require revisional surgery. Autologous reconstructions: When they are radiated, they become contracted and tightened, and may have volume loss and contracture of that flap as well. So we see flaps that shrink in size, that become harder. We get volume loss. So it s really important to determine if a patient is going to need radiation. Reconstruction can also potentially impact the delivery of radiotherapy. So we found that radiation treatment in one study after immediate breast reconstruction were com --- was compromised and many patients, almost 52% of patients, had a compromise in their radiation treatment planning, with the largest compromise on left-sided breast cancers. So this is important to consider when a patient is going to need radiation therapy, if we should perform an immediate reconstruction because we don t want to impact their radiation therapy and their cancer care. Looking at Radiated Flaps: So, when a patient does undergo immediate reconstruction and unfortunately does have radiation to that flap, about 28% of our patients required an additional flap reconstruction for increasing the contour and volume correction. Or they may need to wear an external prosthesis to help with symmetry. So delayed reconstruction is recommended for patients who are likely to require post mastectomy radiation therapy. In certain patients, a babysitting procedure, what we mean by that is placing a tissue expander at the time of a mastectomy to kind of preserve that skin envelope, may be possible. Oftentimes, however, because of the inflated tissue expander may interfere with radiation therapy delivery, we may need to remove that expander or deflate it during radiation therapy. Again, looking at reconstruction and cancer recurrence: So many patients may come to me and ask, Well, if I have a reconstruction, how will I know if my cancer comes back? Or will it interfere with detection of breast cancer recurrence? What we found is that immediate reconstruction, even over a ten-year period, that it did not delay detection of chest wall recurrence. Most recurrences will occur within the skin or subcutaneous tissue, compared to the chest wall. Another study looked at immediate reconstruction patients with all forms of reconstruction as well as comparing those to patients that underwent mastectomy alone without reconstruction, and found that reconstruction did not adversely affect the incidence or time to detection of recurrent breast cancer. And there was no difference

9 between immediate breast reconstruction and mastectomy alone, patients and survival, time to distant metastases or local recurrence. However, the importance of physical exams and symptoms is very important because, really, we don t have any definitive screening tool to look for recurrence in patients that have had a reconstruction. So when patients come to me, examining their skin envelope, asking them for any symptoms, then we can direct our physical exam findings towards more foc --- focused exams. For example, if a patient has a nodule on their skin or subcutaneous tissue that is above our reconstruction, then we can perform an ultrasound or biopsy the area. If there re symptoms, for example, patient may be complaining of chronic pain in that area, soreness. Then, we may want to pursue that further with an ultrasound, a biopsy, or maybe CT scans or MRIs may be warranted to look at deeper structures that may be hidden by the reconstruction. If a recurrence does occur, then treatment may involve surgical excision, the patient may require further chemotherapy, and if they had not had radiation therapy from their prior breast cancer diagnosis, then patients may go on to have radiation therapy. In summary, all forms of reconstruction are associated ris ris --- with risk --- [excuse me] --- and long-term sequelae. Common implant reconstruction late effects include capsular contracture, which is that scar that forms around the implant; implant failure and malposition and rippling. Common latissimus flap reconstruction late effects include implant-related complication, --- complications because an implant is placed oftentimes under the flap, can also have scarring, seromas in the donor site in the back, and potential temporary shoulder weakness that may require physical therapy. Common abdominal flap reconstruction late effects may include abdominal weakness, scarring as well as fat necrosis. We do know that radiotherapy will impact reconstruction more than chemotherapy both in an immediate fashion and delayed. And reconstruction has been found to not interfere with detection of cancer recurrence. Thank you for your attention, and we do welcome any feedback.

can see several late effects. Asymmetry is probably the most common and the thing that patients notice the most. We can also see implant wrinkling or

can see several late effects. Asymmetry is probably the most common and the thing that patients notice the most. We can also see implant wrinkling or Hello, I am Summer Hanson. I m an assistant professor with the Department of Plastic and Reconstructive Surgery at the University of Texas MD Anderson Cancer Center. And today I m going to talk to you

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