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

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1 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 about the late effects of breast reconstruction. Upon completion of this lecture, participants will be able to describe the long-term sequelae of implant-based reconstruction; describe the long term sequelae of autologous reconstruction; understand how adjuvant therapies may affect reconstruction; and determine how reconstruction can affect breast cancer recurrence. We ll jump right in with scarring. This is what patients see as a result of their surgery. As with any surgery, anywhere a surgical incision has been made, we often see scarring. Abnormal scarring can result with tension and patient genetics. Typically this presents as a widened scar. If the scar is widened we can revise it by excising it directly and closing primarily to reduce tension. If the scar goes beyond widened and is actually raised within the boundary of the original wound, we consider that hypertrophic. This can also be revised by excising. We can apply pressure dressings or silicone sheeting. Oftentimes massage and scar cream are able to alleviate. Sometimes we need to inject steroids directly into the scar as it is healing to disrupt the process. Beyond that we can sometimes see keloids. These are raised scars that grow beyond the boundary of the original wound. This can also be addressed through revision with excising and --- and repairing primarily. However, there s a high recurrence rate. Just like the hypertrophic scars we typically apply pressure dressings or silicone sheeting, massage, and scar cream, or steroid injections. In rare cases do we --- do we provide radiation therapy. Patients aren t typically excited about radiation directly applied to their scar but in some cases this is our only option. We also find that aging and weight changes can affect the tissue which can also affect scarring. With aging we see that the epidermis and the subcutaneous fat tend to thin out. The skin strength and elasticity decrease and this is decreased in connective tissue. We see that the blood vessels become more fragile and we may notice this has an impact on the reconstruction. Oftentimes patients will notice more rippling with their implant-based reconstruction. The breast can become more ptotic or what we call bottom out, and that basically just refers to a droop or a drop in the breast shape. And specifically related to the scars, they can become more thin and more fragile-appearing. With weight changes, this can affect the shape and the size of the reconstructed breast. We might notice more changes when one side is reconstructed and the other is a natural breast and this may commonly be cau --- the cause of revisional surgeries to provide better symmetry. Additionally in certain operations we may see that an increase in weight can cause an increase in abdominal complications. Next I m going to talk specifically about the types of reconstruction that we ve addressed in the previous lecture. Specific to implant-based reconstruction we

2 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 rippling, which refers to a change in the contour of the breast based on that thinning or effects of aging. Sometimes we can see implant malposition, where it actually changes position on the chest wall. You can see implant deflation or rupture which usually changes the size of the breast. We see what s called capsular contracture which is a scar that forms around the implant and then contracts down against it. And oftentimes you can see late infection. Asymmetry is more common in unilateral breast reconstruction. It s difficult to match a natural breast with an implant, specifically referring to those effects that we see with aging and weight changes over time. This is probably the most common need for a symmetry procedure after implant-based reconstruction to match one side to the non-reconstructed breast. This is typically a mastopexy, a reduction, or potentially an augmentation where we place an implant under the natural breast as well. Sometimes patients will request a revision due to the size or the shape of the breast. Implant wrinkling refers to a change in the contour of the overlying skin over the implant. With time and aging, as I said, the connective tissue can decrease and the compliance of the implant is transmitted through the skin and this presents as a ripple or a shape in the --- [excuse me] --- a change in the shape. There s minimal coverage over the tissue --- there s minimal tissue coverage over the implant. This is typically skin, a small amount of subcutaneous fat, and the pectoralis major muscle, and sometimes the capsule which is that scar that may form. As the weight of the implant lowers to the lower part of the breast we can often see rippling at the upper pole of the breast due to gravity. Sometimes we are able to overfill the implant in order to hide this. Sometimes we change the shape or the --- the contour of the implant. And sometimes we offer fat grafting or filling with dermal substitute in order to actually improve the contour and to add more tissue to that layer between the skin and the muscle. Implant malposition is where the implant actually changes position on the chest wall. This can be due to scarring around the implant, that capsular contracture, or it could be related to skin laxity and a natural drop. But this can often require surgery to reposition. Sometimes we see implant deflation or rupture. This is different between saline and silicone implants so I ll address both. Saline implant rupture is typically known to the patient right away because the saline leaks into the system and the body absorbs it. It s natural salt water. The breast appears flattened and you can usually see this by physical examination. This requires a replacement surgery --- [excuse me] --- a surgery to replace the implant. Manufacturers report different rates depending on different implants but on average over a one to three-year period it s approximately 5%. With silicone rupture it s a little different. Over the last several decades there have been three generations of silicone-based implants and there s a trend

3 moving towards higher viscosity or cohesive gel. This means that a rupture or deflation can be silent or not even noticed. Typically what happens is there s a crack in the shell of the implant and your body forms scar over it. So what typically --- what patients typically see is a change in the shape or hardening of the breast rather than a true deflation. This can be intracapsular, so within that capsule or within that scar or, if long enough --- have gone on long enough, can be extracapsular. As I said, intracapsular rupture is within the shell, it does not macroscopically extend beyond the capsule, and it s approximately 80-90% of the ruptures that we see. Extracapsular actually ruptures beyond that fibrous capsule and you see macroscopic lea --- leakage of the silicone within the surrounding tissue and it s very rare. Sometimes you can actually see silicone in lymph node sampling. There s been recent data over the last --- the last six-year study period which shows that rupture rates of silicone implants range from about 4% to 10%, depending on the manufacturer. The gold standard to detect this is MRI. As I said, it s not necessarily known through direct deflation and so typically there s a change in the shape or the contour of the breast that presents patients to the clinic. Then we confirm this with an MRI. This is greater than 90% sensitivity and specificity. And typically what they look for is called a linguine sign, where the silicone appears to --- as a ripple within the tissue. In newer generations where we don t see that leakage, you see inverted teardrops, which refers to the contour of the scar around the implant. Capsular contracture is another potentially late effect of breast reconstruction using an implant. This is where there s scar that build up around the breast prosthesis and encapsulates it as a fibrous shell. There are varying degrees of this which have been labeled by the Baker Classification System and I ll just go through that briefly. Grade I is essentially normal. We do expect to see a small amount of scar that builds up around the implant as with any foreign body, so this is normal. Grade II is where there s minimal actual capsular contracture but the patient doesn t really notice the difference, there s no complaint. It s just something that you may detect if you do a revision surgery. Grade III is where there s actual moderate contracture of the breast and change in the shape. Patients typically feel firmness or complain of firmness along the chest wall. And Grade IV is pathologic or severe contracture. This is visibly obvious in the change in shape on the chest wall and there s often firmness that s painful to the patient. We re not entirely sure what causes this but it s typically thought to be because of a foreign body reaction and there are some studies that indicate that perhaps contamination with Staph epidermidis at the time of surgery within the implant placement is --- is a culprit. So we deci --- we discussed irrigating the pocket with antibiotics at the time of mastectomy. Placing the tissue expander or the implant under the muscle at the time of mastectomy gives extra tissue coverage. It s more common in patients that have had reconstruction rather than cosmetic implants, with a rate ranging from [excuse me] --- eight to 36%

4 over one to six years. This is typically a cause of revisional surgery if patients are presenting with that Grade III or Grade IV capsular contracture. Treatment is typically like I said, surgery where we do --- where we perform what s called a capsulotomy, where we open the fibrous capsule and remove some of that scar, or a capsulectomy, where we remove the capsule entirely. If the position of the implant isn t already under the muscle then placing it under the pectoralis major muscle is definitely helpful. Sometimes we need to use autologous tissue from the patient s back or from their belly in order to help with this. Sometimes we can typically perform the capsulectomy and place a different implant, a different type, or texture. There s likely no difference in capsular contracture rates between silicone and saline implants. Historically it s felt that the textured surface will cause less contracture. However, this has actually not been proven to be true in more recent studies. So again, no --- really no difference between the silicone or the saline and the type of texturing that we use. Infection can also be a potentially late effect. Typically, we would see this earlier and something that we would address while they are undergoing their reconstruction. But with time we can see sort of slow growing or indolent infection. As I said, usually it s within four to six weeks postoperative but there s a low incidence of later infection. There s no indication for routine antibiotic prophylaxis for dental procedures but sometimes patients do request this or a dentist actually requests this. There s no data to support this at this time. Typically we would give antibiotics if the patients do have a low grade infection but often we require implant removal and replacement. When we study patient satisfaction following breast reconstruction we see that it s higher in patients that have had silicone-placed implants compared to saline. And I think this is because they re a little bit lighter and less dense and more naturally appearing --- [excuse me] --- natural feeling because of the cohesive gel. We also see that patients are more satisfied who ve had bilateral reconstruction versus unilateral reconstruction and this is because there s a better match or better symmetry. We do find that satisfaction actually decreases over time with both types of implants used and this is likely related to the effects that we see with aging and weight changes, as I spoke about earlier. Postmastectomy radiation has a significant negative effect on breast reconstruction satisfaction and that s true with both types of implants that we see. And it s likely related to a much higher rate of capsular contracture. Implantbased reconstruction is associated with higher revision surgery rates than any type of reconstruction. Breast implant associated ALCL, or Anaplastic Large Cell Lymphoma, is a unique finding that has only come to light in the past several years. In 2011, the US FDA statement said that women with breast implants have a very small risk of developing a very rare type of ALCL within the scar capsule directly adjacent

5 to the implant. There are only 115 reported cases worldwide, which gives an incidence of one in 300,000 patients. We find that this may be associated with textured implants. However, it does occur in both cosmetic and reconstructive patients and is seen in both silicone and saline implants. It is something that we do make our patients aware about --- aware of, however, it s such a rare incidence that it doesn t preclude breast reconstruction with implant. It s usually seen as a late onset seroma. A seroma refers to a fluid collection around the implant. Ultrasound is actually our best way to find this. Sixty percent of these patients will actually have an effusion or fluid collection and only 30% have a mass. Less than 20% end up presenting with symptoms within the lymph nodes. The definitive treatment is removal of the implant and a complete capsulectomy where we remove all of that scar tissue as well as the associated fluid. It there s unresectable or positive margins within that tissue patients may actually receive chemotherapy or local radiation therapy. Additional information is provided at the web sites here for anyone who s interested. Next I will talk about latissimus dorsi breast reconstruction. This is a combination of autologous tissue from the patient s back as well as the placement of an implant. So again the late effects that we see are those related to implant pla --- implant-based reconstruction such as scarring, asymmetry, seroma, and implant issues. And then specific to use of the muscle from the back, which can be muscle contraction, a fullness under the arm along the chest wall, and changes in shoulder biomechanics. Again scarring and asymmetry are true with every type of surgery or every type of reconstruction that we do. Specific to the latissimus dorsi, you may see an increase in the scar or widening of the scar along the donor site of the back. This may require revision once the skin is healed and the tissue has relaxed. Asymmetries are often seen with changes in aging, weight gain, and implant contracture, and again, may require a symmetry procedure. Persistent seroma typically refers to the back donor site and again, as I said, is a fluid collection that can happen at any type during the --- the reconstruction or healing. It s most commonly an early complication in the back given the large surface area of the donor site. This will typically require drainage or placement of a drain and, if persistent, can require the use of sclerosing agents to actually form scar in that back donor site. With time a bursa or capsule can form within that pocket and require surgical removal just like a capsulectomy would require surgical removal. Muscle contraction specific to the latissimus dorsi-based reconstruction depends on the placement of the muscle and whether or not the thoracodorsal nerve has been involved in the surgery. There s always a question of whether or not to cut this. As we re moving the tissue from the back to the front to the chest reconstruction, we re disrupting a lot of the shoulder mechanics or the mechanics of the latissimus dorsi muscle. And so people think that without cutting the --- even without cutting the nerve it will atrophy with time. If you cut the nerve the

6 muscle will atrophy and become so thin that it might not cam --- camouflage the implant and might not provide that extra tissue that you need. However, if you don t cut the muscle --- [excuse me] --- don t cut the nerve, you could potentially continue to have contractions of the muscle over time. Some patients request that the nerve be cut during surgery but this would require a separate procedure. It s often difficult to do due to the scarring after the original reconstruction as well as the location of the nerve directly related to the blood supply of the muscle. The safer answer is to not cut the nerve and have the muscle atrophy with time. There is a possibility of injecting Botox or botulinum toxin to that area but, again, given the proximity to the blood supply requires a very skilled hand. Patients often complain about fullness under the arm and along the chest where the muscle is pedicled or tunneled through from the back to the front. The location of the flap is directly within this tunnel and with time should atrophy and reduce the amount of fullness that they feel. But usually there s always a little bit of asymmetry from one side to the other. If this is true we can often provide liposuction in order to thin out that tissue and reduce the bulk. And then again with the placement of implants there are all of the potential complications or late effects that we discussed just previously. Typically this procedure is performed with an implant in order to improve the shape and the volume of the --- the reconstructed breast. When we refer to shoulder biomechanics there are potentially some changes that can be seen with the latissimus dorsi reconstruction. The latissimus dorsi or the LD is one of 26 muscles that affect the shoulder joint. It typically functions in medial rotation, backward extension, adduction, depressing a raised arm, and is an accessory cough or squeeze muscle. There are six other muscles that act in these similar motions of extension, adduction, internal and external rotation, and they can usually accommodate for removal of the latissimus. With the loss of latissimus muscle there s a synergistic action specifically of the teres major muscle that will lead to hypertrophy and compensation. So there s improvement in time over six to 12 months in the symptoms that patients may see. Typically the actual range of motion, both active and passive, is unchanged. What patients may notice or complain of is faster fatigue on one side to the other in those activities that use extension and adduction. So climbing up a ladder, swinging, doing pull-ups or push-ups from a chair. Physical therapy is definitely helpful to increase strength and range of motion over time. Next I ll talk about autologous tissue from the abdomen and this refers to the TRAM flap, the Transverse Rectus Abdominis Myocutaneous flap; the DIEP flap, DIEP, Deep Inferior Epigastric Perforator flap; or the SIEA, the superior --- [excuse me] --- the Superficial Inferior Epigastric Artery flap. Late effects that we

7 see specific to this type of reconstruction are more commonly seen in the abdominal donor site. Again with any procedure, we see scarring and asymmetry. Specific now to the move --- movement of autologous adipose tissue or fat tissue we can potentially see fat necrosis. And specifically to the abdominal donor site we may see weaknesses such as bulges or hernias. Here the scar that patients are more commonly concerned above is actually along the abdomen from the donor site. This may require revision of the scar once it has healed and the skin tissues have relaxed and there s less tension. Oftentimes patients have paresthesia or sort of a tingling or numbness around the abdominal skin and complain of a belt like sensation at the scar which goes from hip to hip. Typically if they eat a full meal or if they become constipated or bloated they have that sensation around their abdomen as well. Asymmetry, again that we see from one side of the breast reconstruction to the native breast is typically affected by weight loss or gain with patients. Here we re using their own tissue from their abdomen so it will change with them naturally but does change differently than a natural breast would, given the adipose tissues versus glandular tissue. An increase in weight may also put more pressure on the abdomen and increase the laxity of the fascia resulting in a bulge or potentially a hernia. Fat necrosis refers to a decrease in the blood supply or trauma potentially to that fat that s transferred from one part of the body to another and this results in death of fat and scarring. This is thought to be a sterile inflammatory process from asiptic --- aseptic saponification of the fat, basically from tissue and blood lipases. So, what does this mean? Well this actually presents as a hardened area in the reconstruction, either a palpable mass or cyst. Now in patients that have previously had cancer diagnosis this can be very concerning and cause a great amount of distress. Fortunately it s easily distinguished from a cancer recurrence by imaging on ultrasound. And typically if we are concerned we can confirm with a biopsy and you can see specific cellular differences. When my patients present with fat necrosis I have them monitor the area and perform massage in order to try to soften that tissue. Typically we perform ultrasound to confirm the presence of fat necrosis versus anything more concerning and if we need to I can offer excision or liposuction to break up this area and soften that scar. Abdominal weakness can be seen with the autologous reconstruction from the abdomen because we re disrupting some of the connective tissues within the abdominal wall as we separate the fascia, the muscle, and the blood supply of that tissue. That s why there s a trend towards what we call perforator flaps, which is leaving the muscle behind and just taking the perforating blood vessels up to the skin and its adipose tissue. And this has thought to present less abdominal morbidity. I ll briefly describe the differences between bulge and hernia. A bulge refers to a laxity of the abdominal fascia without a true herniation of the bowel con --- contents. And this is typically an aesthetic concern rather

8 than a true medical concern. It can occur with any of the flaps that we talk about that harvest tissue from the abdomen when the muscle is removed or when it s denervated and there s a laxity on the tissue there. Patients who have a pedicle TRAM, where the entire muscle is removed and rotated on its blood supply, may more commonly see a bulge from where that muscle was taken and there s a laxity even in the upper abdomen where the muscle was folded on itself. Hernia refers to a true herniation of the bowel content through a hole in the fascia layer and can often be considered a medical concern or medical emergency if patients present with such obstructive symptoms. This may need an intervention in order to reduce the hernia or repair the abdominal defect particularly if there s strangulation or incarceration. The biggest concern is with bilateral reconstructions where potentially both sides of the abdominal wall have been disrupted. The SIEA flap is a superficial flap and that actually does not involve the fascia layer or the muscle layer and so this is at the lowest risk. Rates of abdominal wall complications are thought to range from anywhere from 3% to 48% depending on the type of flap that we use and depending on whether the procedure was unilateral or bilateral. DIEP patients were found to have one-half the risk of abdominal bulge or hernia compared to free TRAM. And that just refers to a perforator flap versus a flap where we take the entire muscle. However, DIEP f --- DIEP flaps --- [excuse me] --- have a two fold risk of fat necrosis and that s thought to be potentially weakening of the blood supply because we aren t taking the muscle. There s also potentially a higher rate of flap loss. We found there is no difference with fat necrosis or abdominal wall weakness between the muscle sparing TRAM, where we preserve as much of the muscle as we can, versus the DIEP flap which is the perforator flap. Functional deficits that have been assessed --- assessed by physical therapy have shown that patients with a pedicled TRAM, where that entire muscle is taken, experienced the greatest deficit in both the rectus function and the supporting oblique muscle function, and this is up to 53%. Free TRAM has a minimal defect in the rectus muscle function and DIEP flaps have a return to baseline function. So again we re seeing clinically a trend towards preferring the perforator flaps where we leave as much muscle and leave as much enervation as possible. We see subjective measurements of abdominal wall function are similar across unila --- [excuse me] --- unilateral pedicled free TRAM and free DIEP procedures. So with time patient s strength is regained or they accommodate by the other muscles of the core. Muscle sparing flaps compared to DIEP flaps in the una --- unilateral setting likely have no difference but it depends on the amount of muscle taken and the denervation of the existing muscle. When we look at patient satisfaction after autologous reconstruction, so again using their own tissue, and we compare all reconstructive groups, so implants

9 compared to the latissimus dorsi flap which typically has an implant, and abdominal tissue which typically does not have an implant, we see that the autologous reconstruction had a significantly higher general satisfaction and an aesth --- aesthetic satisfaction compared to implant-based reconstruction. Abdominal flaps have significantly higher general and aesthetic --- aesthetic satisfaction, compared to the latissimus dorsi flaps. And there s no difference between patients receiving a pedicled TRAM and those receiving DIEP flaps. So typically we find that patients are more satisfied when we are able to use their own tissue. I d like to talk about adjuvant therapies and potentially the effect that reconstruction can have on adjuvant therapy briefly. Specific to chemotherapy there are two studies that look at adjuvant chemotherapy after immediate breast reconstruction compared to mastectomy alone. And we saw that there was an increase in incidence of wound complications in the patients that had reconstruction, compared to mastectomy alone, just by the nature of having an additional procedure. However, there was no delay in the initiation of adjuvant therapy. The incidence of overall and major postoperative complications, again was higher in the immediate breast reconstruction but there was no significant relationships seen on multivariable analysis. We find that immediate breast reconstruction may be associated with a modest increased time to chemotherapy which was statistically significant but not clinically significant. So on average patients may have been delayed by approximately two weeks in the initiation of their chemotherapy and that s because they potentially had higher complication rates based on their reconstruction. But when we compare this to the improvement in satisfaction and quality of life of immediate reconstruction in patients who are suitable candidates we find that this does not become clinically significant and they are able to complete their adjuvant therapies in a timely fashion. Radiation therapy can have an effect on breast reconstruction in both the timing and the technique that s used. We find that both preoperative and postoperative or post mastectomy radiation therapy will have effects on the reconstruction. Implants ba --- implant-based reconstructions often have a higher rate of pathologic capsular contracture. Autologous reconstruction can be affected by the quality of the chest wall skin that s been radiated if it s constricted or contracted, and specifically radiation to the flap. So if the radiation is performed after the breast reconstruction we see a contracture in that tissue and a significant volume loss. Reconstruction can also potentially impact the delivery of radiation therapy. So radiation treatment planning after immediate reconstruction was com --- compromised in more than half of the patients, approximately 52%, and specifically harder in left-sided cancer patients. We found that 28% of radiated TRAM flap patients required another flap or an external prosthesis in order to account for the changes in contour and volume loss following radiation. Typically we recommend delayed reconstruction in

10 patients who are likely to receive post mastectomy radiation therapy. Let them recover from their adjuvant therapies and the radiation and then perform the reconstruction to really optimize the surgical results. Sometimes we ll place a babysitting TE, or tissue expander, which allows filling of the tiss --- [excuse me] --- filling of the skin envelope after the mastectomy but is only a temporary reconstruction and then we would come back and perform reconstruction using their own tissue either with latissimus dorsi or the abdominal-based tissue. And this allows us to remove or deflate the --- the tissue expander if radiation therapy is necessary. Breast reconstruction has not been shown to interfere with breast cancer recurrence, time to detection, or survival. So this is actually an important question for patients. They often come in asking if having rec --- reconstruction at the time of their mastectomy or even in a delayed fashion will affect their outcome and specifically their concern is the recurrence or their cancer survival. We found that immediate reconstruction over the last 10 years found most recurrences were within the skin or the subcutaneous tissue compared to the chest wall and actual reconstruction did not have an impact on the ability to detect this. The reconstruction did not delay the detection or the treatment. When we compare immediate reconstruction patients with all methods versus mastectomy patients without reconstruction we found that this did not --- did not adversely affect the incidence of time to detection or recurrence of their breast cancer. The importance of physical examination, so continuing to perform their self exams and being aware of any changes in their reconstruction or in the sensations that they are having along the chest wall, is very important for their diagnosis. We also found that there was no difference between immediate breast reconstruction and mastectomy alone in terms of survival, time to distant metastasis, or local recurrence. So again the reconstruction does not affect their --- their outcome or their survival. There s no definitive screening tool for patients who have had reconstruction, however. Mammography is no longer indicated because the breast tissue is gone. Typically we recommend physical examination of the overlying skin and the reconstruction itself and then any symptoms or changes that the patients may notice. We focus these exam findings and determine any imaging that might be needed. So subcutaneous tissue or skin tissues can be detected by ultrasound and biopsy but if there s any concern either a CT or an MRI is --- is warranted if there are any changes noted in the deeper tissues. If cancer recurrence is detected then treatment typically involves surgical incision, chemotherapy, and radiation therapy, again, depending on what their previous adjuvant treatments were. In summary, all forms of reconstruction are associated with potential risks and long term sequelae. The common implant-based reconstruction late effects

11 include capsular contracture, implant failure, and malposition, or potentially rippling. Common latissimus dorsi flap reconstruction late effects include implant related complications, scarring, seromas, and the potential for temporary shoulder weakness. Common abdominal flap reconstruction late effects include abdominal weakness, scarring, and potentially fat necrosis. Radiation therapy will affect the reconstruction more than chemotherapy and may affect both the timing and the technique. However, reconstruction does not interfere with the detection of cancer cur --- recurrence. That concludes my talk. Thank you and we would welcome any feedback.

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