Prof. Fabio Santanelli di Pompeo

Skin Expander and Prosthesis

Breast Reconstruction

About Skin Expander and Prosthesis

Breast reconstruction by means of expander and prosthesis is not the only available option, but the one more often used by most plastic surgeons and the most well-known by patients. It requires a shorter operative time than autologous tissues procedures, but it is always necessary to perform it as a “delayed” procedure because it needs the expansion stage and then the replacement of the expander with a permanent prosthesis. Results are less natural if compared to autologus breast reconstruction such as with DIEP flap, and may entail more complications because of the frequent phenomena of foreign body reaction to prosthesis. Nevertheless, it remains a valid option in selected cases or when patient refuse other procedures.

Silicone gel filled prosthesis were firstly invented in United States, in the 60’s of the last century. Later the well-known conflict among their safety led United States authorities (FDA) to order a moratorium on the use of silicone gel filled prosthesis, waiting for larger clinical studies on their dangerousness (later the absence of any link between silicone gel filled prosthesis and cancer recurrence, other types of tumor or autoimmune disease, has been scientifically demonstrated, as firstly hypothesized). The moratorium gave a strong input to the research of new materials, improving body tolerance and aesthetic results, producing “anatomic” shaped implants and rough shells (texturized) with different surfaces. Another important factor promoting the development of this technique was the manufacture of new and different types of expanders, necessary to recreate the room to locate the permanent prosthesis and to expand the thoracic skin.

In relation to these new products, recently on 2011, the FDA has again raised the attention on the increased incidence of a new type of T cell lymphoma, classified by WHO on 2016 as Breast Implant Associate Anaplastic Large Cell Lymphoma (BIA-ALCL). European competent authorities first started on 2019 to ban a specific type of implant from Allergan, as being consistently link to the occurrence of most of the adverse events. Experts, including Prof. Santanelli di Pompeo di Pompeo, are still working to demonstrate the etiopathogenesis of new tumor. In the meanwhile, the market (industries, physicians and patients) promptly adjusted itself increasing the use of smooth round implants.

The Procedure

Breast reconstruction with skin expander and prosthesis is always carried out in two surgical stages, i.e. “delayed” reconstruction. First stage starts in the operative room, subsequently to the removal of the diseased breast by the general surgeon, and entails the insertion of an expander under the pectoralis major, performed by the plastic surgeon. It is a kind of empty prosthesis that is later filled with saline solution injections in a rate of 10% of its final volume. The filling is performed with a thin needle inserted into a subcutaneous valve, during several outpatient sessions. The progressive increase of the expander recreates, under the pectoralis, the space to locate the definitive prosthesis and contemporarily it slowly expands the thoracic skin that will replace the breast envelope. Few months later the patient will go back to surgery for the replacement with a definitive prosthesis. The Nipple and Areola complex will be reconstructed in a later stage when the prosthesis has settled.

Results

If compared to a reconstruction with autologous tissues, breast envelope often appears less natural in shape and with an absent inframammary fold, and the skin appears also very stiff.

This does not mean that results are not satisfactory and risolutive for the patient. A woman with a breast mound reconstructed in this way may achieve a normal aspect when dressed, and may show a nice décolleté if the reconstruction is successful.

The most important factor to be taken into consideration is about prosthesis-related complications, in particular prosthesis migration, infection and capsule contraction. The latter results from the immunitary system’s attempt to isolate the foreign body, represented by the prosthesis; it is a chronic inflammatory tissue reaction that surrounds the prosthesis, constraining and hardening it, often compromising the cosmetic outcome, sometimes with relevant annoyances.

This problem happens quite often and may require a second procedure to solve it.

If infections occur, they are treated pharmacologically, otherwise, if this is unsuccessful, the prosthesis has to be removed and implanted again a few months after the antibiotic therapy is over. This kind of complication may occur also in reconstructions with Latissimus Dorsi flap and prosthesis, but less frequently because it requires less procedures and mainly because the rich perfusion of the Latissimus Dorsi muscle protects the prosthesis.

Furthermore, before the improvements achieved by microvascular and autologous tissues reconstruction as DIEP flap, the expander and prosthesis procedure played an important role for woman’s breast reconstruction, and still remain an option.

Finally, it is important to take into consideration the different behavior during aging between a breast reconstructed with prosthesis and the natural contralateral breast, or the difference when laying down, as it remains more stiff. 

Some women prefer to solve this problem of asymmetry operating the contralateral breast.

Other Procedures

Permanent Expander

Permanent expander, working also as a definitive prosthesis, has been developed to reach the goal of a “single stage” breast reconstruction. This kind of device has the drawback to have a stiffer look and touch. Women should consider pro and cons of this or of any other implant available nowadays.

Skin Sparing + Prosthesis

When using implants the best results are achieved if the plastic surgeon performs after a “skin sparing mastectomy”, i.e. when the general surgeon, based on certain clinical conditions, has performed a special type of mastectomy, removing only the mammary gland and leaving a certain layer of fat tissue underneath the skin, which is not gland.

In this way, the whole skin of the breast mound is left in place and, when the prosthesis is inserted, the breast retrieves its volume and shape, and the scars end up in the inframammary fold.

An important aspect of this technique is that it can be performed in a single stage, i.e. without the use of an expander, because the skin does not need to be expanded and the prosthesis is isolated from the skin by an intermediate layer of adipose tissue and derma. The ability of the general surgeon in removing the whole gland but preserving vascularity of remaining skin is fundamental for obvious reasons.

In some cases, though, the layer of tissue close to the skin is too thin and it is necessary to closely evaluate the situation to avoid the risk of consequent superficialization of the prosthesis, showing distortion and wrinkles of the breast skin or, worse, “wearing out” and damaging the skin.

This technique is known as Skin sparing + prosthesis and it cannot be exempt from implant-related complications.

Frequently Asked Questions

Q: May the prosthesis unleash a breast tumor relapse or other oncological diseases?

A: Absolutely not a recurrence. All major scientific publications agree that a correlation between tumor relapse, or other neoplastic diseases, and the use of prosthesis cannot be demonstrated. In Europe, the controversy about silicone gel implants contributed to the publication of Directive 93/42 EEC, that became effective in all member states in June 15 1998, after a transitory period (from 1995 to 1998). According to this Directive prostheses fell within risk category 2. On February 4 2003 the European Commission adopted the Directive 2003/12 that reclassified breast prostheses to risk category 3, with a more complex process to obtain the declaration of conformity. Texturized implants or if covered by polyurethane foam, may be responsible for occurrence of a new type of lymphoma (BIA-ALCL), for this reason Prof. Santanelli di Pompeo is not using it any longer.

Q: Could the prosthesis get damaged?

A: It is quite difficult for a breast prosthesis to get damaged without a traumatic event. However, even in case of a direct trauma to the breast, the damage of the implant is a rare instance. Although, when undergoing follow-up examinations, such as mammography, it is important to refer to specialized centers, also because the instrumental examination of a breast reconstructed with implant must be carried out by experienced and specifically trained physicians.

Q: Is prosthesis compatible with chemotherapy and radiotherapy?

A: Breast implants have no effects on chemotherapy, and vice-versa. Instead, whether to perform radiotherapy or not on a breast reconstructed with prosthesis, must be closely evaluated because it could lead to a rejection phenomenon. Thus, it is suggested to undergo radiotherapy before breast reconstruction.

Q: Will I need to undergo prosthesis replacement in the future?

A: Technically prostheses are made to last up to twenty years. Their replacement depends on external factors, as the above-mentioned complications. Defects or dislocation of the prosthesis are quite common and may arise over time. Many women may comply with it and cohabit with an unfavorable situation, while in other cases is the patient herself to ask for a replacement.

Q: I have deeply considered all reconstruction possibilities and, even though I might be a good candidate for reconstruction with autologous tissues, I do not want to undergo this kind of procedure. I prefer to use a prosthesis.

A: Plastic surgeons can indicate what their experience suggests to be the optimal reconstructive option, considering, among other things, long-term results. However, what you desire for yourself and what you feel like doing to your own body is, first, your own choice. Therefore, our commitment to you is to determine the best reconstructive technique among those that require the use of prosthesis, to meet your demands as best as we can.

About Skin Expander and Prosthesis

Breast reconstruction by means of expander and prosthesis is not the only available option, but the one more often used by most plastic surgeons and the most well-known by patients. It requires a shorter operative time than autologous tissues procedures, but it is always necessary to perform it as a “delayed” procedure because it needs the expansion stage and then the replacement of the expander with a permanent prosthesis. Results are less natural if compared to autologus breast reconstruction such as with DIEP flap, and may entail more complications because of the frequent phenomena of foreign body reaction to prosthesis. Nevertheless, it remains a valid option in selected cases or when patient refuse other procedures.

Silicone gel filled prosthesis were firstly invented in United States, in the 60’s of the last century. Later the well-known conflict among their safety led United States authorities (FDA) to order a moratorium on the use of silicone gel filled prosthesis, waiting for larger clinical studies on their dangerousness (later the absence of any link between silicone gel filled prosthesis and cancer recurrence, other types of tumor or autoimmune disease, has been scientifically demonstrated, as firstly hypothesized). The moratorium gave a strong input to the research of new materials, improving body tolerance and aesthetic results, producing “anatomic” shaped implants and rough shells (texturized) with different surfaces. Another important factor promoting the development of this technique was the manufacture of new and different types of expanders, necessary to recreate the room to locate the permanent prosthesis and to expand the thoracic skin.

In relation to these new products, recently on 2011, the FDA has again raised the attention on the increased incidence of a new type of T cell lymphoma, classified by WHO on 2016 as Breast Implant Associate Anaplastic Large Cell Lymphoma (BIA-ALCL). European competent authorities first started on 2019 to ban a specific type of implant from Allergan, as being consistently link to the occurrence of most of the adverse events. Experts, including Prof. Santanelli di Pompeo di Pompeo, are still working to demonstrate the etiopathogenesis of new tumor. In the meanwhile, the market (industries, physicians and patients) promptly adjusted itself increasing the use of smooth round implants.

The Procedure

Breast reconstruction with skin expander and prosthesis is always carried out in two surgical stages, i.e. “delayed” reconstruction. First stage starts in the operative room, subsequently to the removal of the diseased breast by the general surgeon, and entails the insertion of an expander under the pectoralis major, performed by the plastic surgeon. It is a kind of empty prosthesis that is later filled with saline solution injections in a rate of 10% of its final volume. The filling is performed with a thin needle inserted into a subcutaneous valve, during several outpatient sessions. The progressive increase of the expander recreates, under the pectoralis, the space to locate the definitive prosthesis and contemporarily it slowly expands the thoracic skin that will replace the breast envelope. Few months later the patient will go back to surgery for the replacement with a definitive prosthesis. The Nipple and Areola complex will be reconstructed in a later stage when the prosthesis has settled.

Results

If compared to a reconstruction with autologous tissues, breast envelope often appears less natural in shape and with an absent inframammary fold, and the skin appears also very stiff.

This does not mean that results are not satisfactory and risolutive for the patient. A woman with a breast mound reconstructed in this way may achieve a normal aspect when dressed, and may show a nice décolleté if the reconstruction is successful.

The most important factor to be taken into consideration is about prosthesis-related complications, in particular prosthesis migration, infection and capsule contraction. The latter results from the immunitary system’s attempt to isolate the foreign body, represented by the prosthesis; it is a chronic inflammatory tissue reaction that surrounds the prosthesis, constraining and hardening it, often compromising the cosmetic outcome, sometimes with relevant annoyances.

This problem happens quite often and may require a second procedure to solve it.

If infections occur, they are treated pharmacologically, otherwise, if this is unsuccessful, the prosthesis has to be removed and implanted again a few months after the antibiotic therapy is over. This kind of complication may occur also in reconstructions with Latissimus Dorsi flap and prosthesis, but less frequently because it requires less procedures and mainly because the rich perfusion of the Latissimus Dorsi muscle protects the prosthesis.

Furthermore, before the improvements achieved by microvascular and autologous tissues reconstruction as DIEP flap, the expander and prosthesis procedure played an important role for woman’s breast reconstruction, and still remain an option.

Finally, it is important to take into consideration the different behavior during aging between a breast reconstructed with prosthesis and the natural contralateral breast, or the difference when laying down, as it remains more stiff. 

Some women prefer to solve this problem of asymmetry operating the contralateral breast.

Other Procedures

Permanent Expander

Permanent expander, working also as a definitive prosthesis, has been developed to reach the goal of a “single stage” breast reconstruction. This kind of device has the drawback to have a stiffer look and touch. Women should consider pro and cons of this or of any other implant available nowadays.

Skin Sparing + Prosthesis

When using implants the best results are achieved if the plastic surgeon performs after a “skin sparing mastectomy”, i.e. when the general surgeon, based on certain clinical conditions, has performed a special type of mastectomy, removing only the mammary gland and leaving a certain layer of fat tissue underneath the skin, which is not gland.

In this way, the whole skin of the breast mound is left in place and, when the prosthesis is inserted, the breast retrieves its volume and shape, and the scars end up in the inframammary fold.

An important aspect of this technique is that it can be performed in a single stage, i.e. without the use of an expander, because the skin does not need to be expanded and the prosthesis is isolated from the skin by an intermediate layer of adipose tissue and derma. The ability of the general surgeon in removing the whole gland but preserving vascularity of remaining skin is fundamental for obvious reasons.

In some cases, though, the layer of tissue close to the skin is too thin and it is necessary to closely evaluate the situation to avoid the risk of consequent superficialization of the prosthesis, showing distortion and wrinkles of the breast skin or, worse, “wearing out” and damaging the skin.

This technique is known as Skin sparing + prosthesis and it cannot be exempt from implant-related complications.

Frequently Asked Questions

Q: May the prosthesis unleash a breast tumor relapse or other oncological diseases?

A: Absolutely not a recurrence. All major scientific publications agree that a correlation between tumor relapse, or other neoplastic diseases, and the use of prosthesis cannot be demonstrated. In Europe, the controversy about silicone gel implants contributed to the publication of Directive 93/42 EEC, that became effective in all member states in June 15 1998, after a transitory period (from 1995 to 1998). According to this Directive prostheses fell within risk category 2. On February 4 2003 the European Commission adopted the Directive 2003/12 that reclassified breast prostheses to risk category 3, with a more complex process to obtain the declaration of conformity. Texturized implants or if covered by polyurethane foam, may be responsible for occurrence of a new type of lymphoma (BIA-ALCL), for this reason Prof. Santanelli di Pompeo is not using it any longer.

Q: Could the prosthesis get damaged?

A: It is quite difficult for a breast prosthesis to get damaged without a traumatic event. However, even in case of a direct trauma to the breast, the damage of the implant is a rare instance. Although, when undergoing follow-up examinations, such as mammography, it is important to refer to specialized centers, also because the instrumental examination of a breast reconstructed with implant must be carried out by experienced and specifically trained physicians.

Q: Is prosthesis compatible with chemotherapy and radiotherapy?

A: Breast implants have no effects on chemotherapy, and vice-versa. Instead, whether to perform radiotherapy or not on a breast reconstructed with prosthesis, must be closely evaluated because it could lead to a rejection phenomenon. Thus, it is suggested to undergo radiotherapy before breast reconstruction.

Q: Will I need to undergo prosthesis replacement in the future?

A: Technically prostheses are made to last up to twenty years. Their replacement depends on external factors, as the above-mentioned complications. Defects or dislocation of the prosthesis are quite common and may arise over time. Many women may comply with it and cohabit with an unfavorable situation, while in other cases is the patient herself to ask for a replacement.

Q: I have deeply considered all reconstruction possibilities and, even though I might be a good candidate for reconstruction with autologous tissues, I do not want to undergo this kind of procedure. I prefer to use a prosthesis.

A: Plastic surgeons can indicate what their experience suggests to be the optimal reconstructive option, considering, among other things, long-term results. However, what you desire for yourself and what you feel like doing to your own body is, first, your own choice. Therefore, our commitment to you is to determine the best reconstructive technique among those that require the use of prosthesis, to meet your demands as best as we can.

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Healing is a process that can be considered complete when, finally, you might recognize yourself into your own body, despite unavoidable changes...

In the last decades Plastic Surgery, has become part of the oncologic treatment protocol, as the importance of the reconstructive stage following resection of a diseased body part has been universally recognized. Concerning breast tumor, most advanced hospitals set up a “Breast Unit”, multidisciplinary functional unit composed by different specialists who cooperate to offer to the patient the best opportunity available from medical science, to contrast tumor disease and return to normal life.

There are several breast reconstructive procedures, even though expander and prosthesis is the most known. This web-site is dedicated to women undergoing mastectomy and willing to know all reconstructive opportunities. Main goal is to present “autologous” procedures using live tissues from the patient itself as a sort of “auto-transplant”. Advances in vascular microsurgery and in peri-operative patient care have allowed for outstanding steps forward to restore the female body image.

Once all aspects have been taken into proper consideration, a woman should be assisted during choice with broad information, evaluating pro and cons among any surgical procedure, so she can decide what is best for her.