Original article

Use of bilateral prophylactic nipple-sparing mastectomy

in patients with high risk of breast cancer
M. G. Valero1 , T.-A. Moo1 , S. Muhsen1 , E. C. Zabor2 , M. Stempel1 , A. Pusic3 , M. L. Gemignani1 ,
M. Morrow1 and V. Sacchini1
1 BreastService, Department of Surgery, and 2 Biostatistics Service, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer
Center, New York, and 3 Division of Plastic Surgery, Brigham and Women’s Hospital at Harvard Medical School, Boston, Massachusetts, USA
Correspondence to: Dr V. Sacchini, Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 300 East 66th Street, New York
10065, USA (e-mail: sacchinv@mskcc.org)

Background: Nipple-sparing mastectomy (NSM) is being performed increasingly for risk reduction in
high-risk groups. There are limited data regarding complications and oncological outcomes in women
undergoing bilateral prophylactic NSM. This study reviewed institutional experience with prophylactic
NSM, and examined the indications, rates of postoperative complications, incidence of occult malignant
disease and subsequent breast cancer diagnosis.
Methods: Women who had bilateral prophylactic NSM between 2000 and 2016 were identified from
a prospectively maintained database. Rates of postoperative complications, incidental breast cancer,
recurrence and overall survival were evaluated.
Results: A total of 192 women underwent 384 prophylactic NSMs. Indications included BRCA1 or
BRCA2 mutations in 117 patients (60⋅9 per cent), family history of breast cancer in 35 (18⋅2 per cent),
lobular carcinoma in situ in 29 (15⋅1 per cent) and other reasons in 11 (5⋅7 per cent). Immediate breast
reconstruction was performed in 191 patients. Of 384 NSMs, 116 breasts (30⋅2 per cent) had some
evidence of skin necrosis at follow-up, which resolved spontaneously in most; only 24 breasts (6⋅3 per cent)
required debridement. Overall, there was at least one complication in 129 breasts (33⋅6 per cent); 3⋅6 and
1⋅6 per cent had incidental findings of ductal carcinoma in situ and invasive breast cancer respectively.
The nipple–areola complex was preserved entirely in 378 mastectomies. After a median follow-up of
36⋅8 months, there had been no deaths and no new breast cancer diagnoses.
Conclusion: These findings support the use of prophylactic NSM in high-risk patients. The nipples could
be preserved in the majority of patients, postoperative complication rates were low, and, with limited
follow-up, there were no new breast cancers.
Presented to the 19th Annual Meeting of the American Society of Breast Surgeons, Orlando, Florida, USA, May 2018

Paper accepted 14 March 2020

Published online 20 May 2020 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.11616

Introduction method for risk reduction in this population, with a 93

Nipple-sparing mastectomy (NSM) provides patients the
opportunity to preserve the nipple–areola complex and
provides a more natural cosmetic result than traditional
skin-sparing mastectomy. This procedure is being per-
formed increasingly1 in the prophylactic setting among
patients at increased risk of developing breast cancer, such
as those with a genetic predisposition, strong family history
or atypia.
Women with a BRCA mutation have a risk of developing
breast cancer of 60–80 per cent during their lifetime2 – 4 .
Prophylactic NSM5 has been shown to be an effective
per cent relative risk reduction6,7 . Ideal candidates for
NSM include women with small breasts, absence of pto-
sis, low BMI and those who are not active smokers8 .
Nonetheless, single-institution studies1,9 have reported
similarly on the expansion of the eligibility criteria for
NSM over time to include women with larger breasts,
without compromising oncological outcomes. The more
desirable cosmetic outcomes achieved with preservation of
the nipple–areola complex have shown quality-of-life ben-
efits. Patients undergoing NSM have better psychosocial
and sexual well-being, and improved cosmesis, body image

© 2020 BJS Society Ltd BJS 2020; 107: 1307–1312

Published by John Wiley & Sons Ltd
1308 M. G. Valero, T.-A. Moo, S. Muhsen, E. C. Zabor, M. Stempel, A. Pusic et al.

and nipple sensation10 – 15 . Concerns, however, remain Fig. 1 Institutional trends in prophylactic nipple-sparing
regarding the oncological safety of the procedure because mastectomy
of the potential for residual breast tissue beneath the
nipple–areola complex or elsewhere on the chest wall, 25
and the lack of long-term outcome data for patients at
highest risk of developing breast cancer16 – 19 . Short-term 20

No. of procedures
studies20 – 25 have reported a low incidence of occult can-
15
cer after prophylactic mastectomy; however, long-term
follow-up is lacking. 10
In 2011, a recent NSM experience at Memorial Sloan
Kettering Cancer Center was reported20 including 196 5
prophylactic procedures. The goal of this study was to
0
review and provide an updated follow-up of the indica-

20 0
01

20 2
20 3
20 4
20 5
06

20 7
20 8
20 9
20 0
11

20 2
20 3
20 4
20 5
16
0

0
0
0
0

0
0
0
1

1
1
1
1
tions, complications and incidence of occult malignan-

20

20

20

20
cies for bilateral prophylactic NSM performed at this Year of surgery

institution.

Methods
The study was approved by the Institutional Review
Board of Memorial Sloan Kettering Cancer Center, New
York. Informed consent was obtained from all participants
included in the study. All procedures were in accordance
with the ethical standards of the institutional and/or
national research committee, and with the 1964 Helsinki
Declaration and its later amendments or comparable
ethical standards.
Memorial Sloan Kettering Cancer Center’s prospectively
maintained breast database was queried to identify patients
who underwent bilateral prophylactic NSM between Jan-
uary 2000 and December 2016. Patients with known
invasive breast cancer or ductal carcinoma in situ (DCIS)
undergoing NSM were excluded. An electronic medical
records review was performed to update the follow-up
status for each patient. Variables retrieved for the analy-
sis included: age; family history of breast/ovarian cancer
(at least 1 first- or second-degree family member with
breast cancer); genetic testing, if performed, and mutations
detected; smoking status at the time of surgery; history
of radiation; use of preoperative MRI; history of cancer
(except breast); and type of reconstruction.
Information on complications, such as nipple excision,
need for reoperation, skin desquamation (defined as
partial-thickness skin loss not requiring surgical debride-
ment), skin necrosis (full-thickness skin loss requiring
surgical debridement), development of haematoma and
need for implant/expander removal, was obtained by
review of the records. All procedures were performed
at Memorial Sloan Kettering Cancer Center by a breast
surgeon and a plastic surgeon. Each mastectomy was
considered an individual event.
Statistical analysis
Patient and disease characteristics are summarized as
median (range) for continuous data, and frequency (per-
centage) for categorical variables. Overall survival was
estimated from the date of surgery to date of death. Time
to a new breast cancer diagnosis was estimated from date
of surgery to date of diagnosis. All statistical analyses
were conducted using R software version 3.4.1 (R Core
Development Team, Vienna, Austria).
Results
Between January 2000 and December 2016, 192 women
underwent bilateral prophylactic NSMs. Fig. 1 shows the
time trend for the use of the procedure. The median
age for the entire cohort was 41⋅5 (range 23–65) years
(Table 1). Among the 192 patients, 125 (65⋅1 per cent)
had at least one first-degree relative with breast cancer
and 19 (9⋅9 per cent) had at least one first-degree relative
with ovarian cancer. Genetic testing was performed in 148
patients (77⋅1 per cent). The majority of patients (145,
75⋅5 per cent) had never smoked, 43 (22⋅4 per cent) were
former smokers, and only four (2⋅1 per cent) were cur-
rent smokers. Twenty-one women had received radiation
therapy previously in one or both breasts, either for a
breast cancer or mantle radiation. Preoperative MRI was
undertaken in 142 patients (74⋅0 per cent).
Prophylactic NSMs were performed for BRCA mutations
in 117 of the 192 women (60⋅9 per cent), and for ATM
and CHEK2 mutations in two (1⋅0 per cent); the indication
was lobular carcinoma in situ (LCIS) in 29 women (15⋅1
per cent), and family history or personal history of breast

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Use of bilateral prophylactic nipple-sparing mastectomy 1309

Table 1 Patient characteristics Table 3 Complications among prophylactic procedures

No. of patients* (n = 192) No. of breasts (n = 384)

Age (years)† 41⋅5 (23–65) Any complication 129 (33⋅6)

Family history Nipple excision 6 (1⋅6)
Breast cancer (≥ 1st-degree relative) 125 (65⋅1) Reoperation for complication 16 (4⋅2)
Ovarian cancer (≥ 1st-degree relative) 19 (9⋅9) Skin desquamation 116 (30⋅2)
Genetic testing 148 (77⋅1) Skin necrosis 24 (6⋅3)
No mutation detected 24 (16⋅2) Haematoma 5 (1⋅3)
BRCA1 mutation 72 (48⋅6) Implant/expander removal 8 (2⋅1)
BRCA2 mutation 45 (30⋅4) Infection 16 (4⋅2)
BRCA1 – VUS 1 (0⋅7)
Values in parentheses are percentages.
BRCA2 – VUS 4 (2⋅7)
CHEK2 mutation 1 (0⋅7)
ATM mutation 1 (0⋅7) The nipple–areola complex was ultimately preserved in
History of cancer (not breast) 13 (6⋅8) 378 of 384 breasts (98⋅4 per cent); six nipples were excised
History of breast cancer 8 (4⋅2)
(1⋅6 per cent), three (0⋅8 per cent) owing to incidental
Smoking status
DCIS at the nipple margin, and the rest because of necro-
Never smoker 145 (75⋅5)
sis. Some degree of skin desquamation was present in
Former smoker 43 (22⋅4)
Current smoker 4 (2⋅1)
116 breasts (30⋅2 per cent), but this was usually mild and
Preoperative MRI 142 (74⋅0)
resolved fully without intervention (Table 3). Twenty-four
Type of reconstruction breasts (6⋅2 per cent) had skin necrosis requiring debride-
No reconstruction 1 (0⋅5) ment. Sixteen breasts (4⋅2 per cent) had a complication that
Permanent implant 10 (5⋅2) required reoperation, and implant removal was necessary
Tissue expander 176 (91⋅7) in eight (2⋅1 per cent). Sixteen patients (4⋅2 per cent) were
Autologous flap 5 (2⋅6) treated for infection.
*With percentages in parentheses unless indicated otherwise; †values are
Of the 384 breasts, 20 (5⋅2 per cent) harboured unsus-
median (range). VUS, variants of uncertain significance. pected cancers; three (0⋅8 per cent) were invasive ductal
carcinomas, 14 (3⋅6 per cent) were DCIS only and three
(0⋅8 per cent) were invasive lobular carcinomas only.
After a median follow-up of 36⋅8 (range 1⋅3–194)
Table 2 Indications for prophylactic nipple-sparing mastectomy
months, there had been no new breast cancer diagnoses or
No. of patients (n = 192) deaths.
BRCA mutation 117 (60⋅9)
ATM mutation 1 (0⋅5)
Discussion
CHEK2 mutation 1 (0⋅5)
Family history 35 (18⋅2) Prophylactic bilateral NSM is considered as an option to
Lobular carcinoma in situ 29 (15⋅1) decrease the risk of developing breast cancer in BRCA1/2
Risk reduction 3 (1⋅6)
mutation carriers and high-risk women. The overall
History of breast cancer 4 (2⋅1)
survival benefit is, however, not clearly defined in the
History of radiation therapy 2 (1⋅0)
literature26,27 . A recent multicentre study28 evaluated the
Values in parentheses are percentages. associations between bilateral breast reduction mastec-
tomy, and overall and breast cancer-specific mortality rates
for BRCA1 and BRCA2 mutation carriers separately. The
cancer in 35 (18⋅2 per cent) and four (2⋅1 per cent) respec- authors reported lower overall and breast cancer-specific
tively (Table 2). mortality rates among BRCA1 mutation carriers opting
Almost all patients underwent immediate breast recon- for risk-reduction mastectomy than among those kept
struction, including tissue expander reconstructions in 176 under surveillance; however, for BRCA2 mutation carriers,
(91⋅7 per cent), direct-to-implant procedures in ten (5⋅2 per surgery was not significantly associated with improvements
cent) and autologous flap procedures in five (2⋅6 per cent). in overall survival compared with surveillance. Ultimately,
Only one woman (0⋅5 per cent) preferred not to undergo prophylactic mastectomy provides the greatest reduction
reconstruction. in risk of breast cancer development. Improved cosmetic

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Published by John Wiley & Sons Ltd
1310
outcomes have led to its increased use as a risk-reducing
procedure in this group of women.
In the present cohort, most women undergoing bilateral
prophylactic NSM were BRCA1/2 carriers (60⋅9 per cent),
followed by women with a family history of breast cancer
(18⋅2 per cent) and those with a diagnosis of LCIS (15⋅1 per
cent). These groups represent a population with a lifetime
risk of developing breast cancer that ranges from 60 to
70 per cent in BRCA carriers2 – 4 , and from 15 to 30 per
cent in women with LCIS29 – 31 . As a result, there have
been concerns regarding whether or not this technique is
appropriate in such a population.
Although there have been no RCTs comparing NSM
with skin-sparing or simple mastectomy, the safety of the
technique has been validated in both prophylactic and
therapeutic settings in multiple prospective series. The
major concerns with NSM, however, include its oncologi-
cal safety and the appropriate surgical technique. Previous
studies5,32 – 35 have demonstrated that NSM leaves a small
amount of ductal tissue behind the nipple. Additionally,
this technique requires the mastectomy to be performed
through a smaller, more cosmetic incision, possibly lead-
ing to inadequate removal of breast tissue. This has raised
oncological concerns regarding the potential for increasing
local recurrence risk32,36 .
In a series37 of 150 patients (298 breasts) undergoing
NSM for risk reduction, occult disease was found in only
four patients (2⋅7 per cent) and, after a mean follow-up of
32⋅6 (range 1–76) months, there was only one cancer event
and no disease at the nipple–areola complex. Several other
retrospective studies, with follow-up ranging from 6 weeks
to 92 months, reported excellent results after treatment
with NSM for risk reduction38 .
In the present study, after a median follow-up of
36⋅8 months, there were no local recurrences among
patients with incidental invasive breast cancer or DCIS,
and no new diagnoses of breast cancer in those who had
prophylactic surgery. Although this study evaluated a
cohort of patients with a high or moderately increased
breast cancer risk without previous evidence for a diag-
nosis of breast cancer, the findings support previous
reports34,39 – 41 that NSM is an oncologically safe prophy-
lactic option for women at increased risk of developing
breast cancer, at least with short follow-up.
The results of previous retrospective studies33 – 35,42
evaluating whether this technique has a higher risk of
perioperative complications, such as skin flap necro-
sis, reoperation, nipple loss, infection and haematoma,
have been inconsistent. A more contemporary study43
has reported an increased risk of skin flap necrosis with
the use of NSM. Major complications were infrequent
© 2020 BJS Society Ltd
Published by John Wiley & Sons Ltd
M. G. Valero, T.-A. Moo, S. Muhsen, E. C. Zabor, M. Stempel, A. Pusic et al.
in the present study, with 116 women (30⋅2 per cent)
having some degree of skin necrosis at follow-up. Nev-
ertheless, this resolved spontaneously in most patients,
with only 24 breasts (6⋅2 per cent) requiring debride-
ment. Other complications, including wound infection,
expander/implant removal and haematoma were noted
in 1⋅3–4⋅2 per cent of patients. NSM divides the blood
supply to the nipple–areola complex, which can result in
ischaemia. Here, nipple–areola complexes were preserved
entirely in 378 mastectomies; only three required nip-
ple excisions secondary to some degree of nipple–areola
complex necrosis. The rate of nipple–areola complex
necrosis in this study supports the premise that NSM can
be performed with a low rate of necrosis similar to that
reported in the literature39,40,44 – 47 .
Strengths of this study include its evaluation of a large
cohort of patients who underwent prophylactic NSM over
an extended period. The results suggest that NSM in
the prophylactic setting did not affect oncological out-
comes. Limitations of this study include its retrospective
nature. The absence of any breast cancer diagnoses dur-
ing the follow-up of 36⋅8 months suggests that NSM may
be oncologically safe in this patient group; however, longer
follow-up is needed to establish the long-term safety of the
procedure.
Acknowledgements
The preparation of this study was funded in part by
National Institutes of Health/National Cancer Institute
Cancer Center Support Grant P30 CA008748 to Memo-
rial Sloan Kettering Cancer Center. The study research
has not been preregistered previously in an independent,
institutional registry. The data and methods used in the
analysis, and materials used to conduct the research, will
be made available upon request by the authors. M.M.
has received honoraria from Genomic Health and Roche.
A.P. is a co-developer of the BREAST-Q and receives
royalties when the questionnaire is used in for-profit
industry-sponsored clinical trials.
Disclosure: The authors declare no other conflict of interest.
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