INTRODUCTION
The search for an anatomical substitute for the breast to correct aesthetic problems,
hypoplasia or hypotrophy, has a long history of failures until the arrival of silicone.
Since the beginning of its use in the 1960s, many complications have arisen and have
always been the nightmare of any surgeon, such as capsular contracture, capsule rupture,
and calcification, in addition to silicone leakage into the surrounding structures,
generating local manifestations1.
Several alterations were attempted in the capsule and the silicone to avoid such complications,
such as the thickness and texture of the capsule, the polyurethane cover in the 1970s2, and the cohesive gel, in the 1990s3. Since then, silicone implants have increased applicability in breast augmentation
and reduction surgeries, as well as correction of ptosis4,5,6, corroborated by the exponential increase in the number of studies on the subject7.
We did not find a report on the passage of materials from the body into implants in
the current literature.
OBJECTIVE
The present study seeks, through identification by infrared spectrophotometry (FTIR),
combined with observation and careful clinical analysis, carried out over more than
20 years, of 1500 pairs of breast implants surgically removed, to report the passage
of organic substances to the interior of breast implants without showing damage, cracks
or violation of any of their capsules.
METHOD
The present work clinically analyzed a sample of 1500 pairs of breast implants surgically
removed from 1998 to 2018, showing changes in volume, shape, and color between units
of the same pair (Figures 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10). Six pairs were sent for analysis by comparative qualitative chemical identification
by infrared spectrophotometry (FTIR) before and after sample preparation by acetone
solvent extraction.
Figure 1 - First implant found more than 20 years ago with a substance inside.
Figure 1 - First implant found more than 20 years ago with a substance inside.
Figure 2 - Patient with enlargement of the left breast after 3 years of implantation.
Figure 2 - Patient with enlargement of the left breast after 3 years of implantation.
Figure 3 - Pair of textured submuscular implants, explanted after 3 years of use. It can be seen
on the left showing a yellowish color and an increase of 30ml. Whenever the implant
changes its original color, there is fat inside it.
Figure 3 - Pair of textured submuscular implants, explanted after 3 years of use. It can be seen
on the left showing a yellowish color and an increase of 30ml. Whenever the implant
changes its original color, there is fat inside it.
Figure 4 - A: Original prosthesis 255cc polyurethane and 300cc with volume increase by substances
inside. B: Same inverted prostheses. C: Transoperative explantation.
Figure 4 - A: Original prosthesis 255cc polyurethane and 300cc with volume increase by substances
inside. B: Same inverted prostheses. C: Transoperative explantation.
Figure 5 - Patient with increased volume in the left breast after 8 years of implantation. Two
pregnancies in the period.
Figure 5 - Patient with increased volume in the left breast after 8 years of implantation. Two
pregnancies in the period.
Figure 6 - Silimed® implant 215cc polyurethane. By transillumination, the substance is observed
inside the prosthesis.
Figure 6 - Silimed® implant 215cc polyurethane. By transillumination, the substance is observed
inside the prosthesis.
Figure 7 - Silimed® implant 215cc polyurethane. Increased to 300cc after 8 years of use.
Figure 7 - Silimed® implant 215cc polyurethane. Increased to 300cc after 8 years of use.
Figure 8 - Menthor 225cc implant, 5 years old, in transillumination.
Figure 8 - Menthor 225cc implant, 5 years old, in transillumination.
Figure 9 - 280cc Pherthese implant showing heterogeneity inside.
Figure 9 - 280cc Pherthese implant showing heterogeneity inside.
Figure 10 - Silimed® 355cc implant, removed after 4 years of use.
Figure 10 - Silimed® 355cc implant, removed after 4 years of use.
Three materials were analyzed, one of which was an implant surgically explanted after
years of use, showing macroscopic changes inside, without capsule violation. A second
sample was performed on a similar but unused implant. The third material was a breast
fat tissue sample removed from the patient during surgery. Comparative analysis was
performed between all materials and the reference, and all samples were compared.
There was also an evaluation of other materials found inside, different from silicone.
RESULTS
Materials compatible with fat (fatty acid ester), animal protein (hydrolyzed animal
protein), and hemoglobin (protein of hemoglobin) were found inside the implant, altered
after years of use, with no cracks or leaks in the external capsule. The breast fat
sample was compatible with the material found inside the altered implant and the laboratory
reference. Meanwhile, the only material found in the unused implant was polydimethylsiloxane,
evidenced inside both samples, regardless of use, as expected.
DISCUSSION
Despite the evolution of breast implants, with changes in the gel of their content
and the elastomer (wrap), complications such as capsular contracture, rupture, and
microleakage persist7. The literature presents many studies of silicone migration to contiguous breast
tissue and adjacent lymphatic tissue, but no publication is found on the migration
of organic tissue from the patient’s body to the interior of the silicone breast prosthesis2,3.
In daily clinical practice (private clinic) dedicated to many breast surgeries, approximately
1500 cases of pair exchanges of silicone breast implants were performed, the vast
majority due to capsular contracture and the silicone prosthesis rupture and aesthetic
dissatisfaction of the patients.
In this 20-year series (1998 to 2018), some samples were noted that were above normal
in size and weight (observation with the naked eye) and also with changes in the color
of their contents, predominantly yellowish tones, but without signs of damage, cracks
or violation of any of the implant casing.
In this way, without many resources at that time, the observation was carried out
through transillumination, which did not bring technical analysis or veracity, but
sharpened curiosity even more. The study continued with the six pairs sent for analysis
by comparative qualitative chemical identification by infrared spectrophotometry (FTIR).
Materials compatible with fat (fatty acid ester), animal protein (hydrolyzed animal
protein), and hemoglobin (protein of hemoglobin) were found inside the implants. In
order to corroborate that the fat tissue found inside the implant could even be human
and from the same patient, a small breast fat sample was resected, which served as
a parameter and was compatible with the material found inside the altered implant,
as well as with the laboratory reference.
This demonstrates the migration of organic components into the silicone prosthesis,
proving that the possible microcracks allow the passage of content from the inside
to the outside and in the opposite direction, from the outside to the inside.
CONCLUSION
The breast implant presents interaction with the organism, with the passage of substances,
mainly lipids (fatty acid), animal proteins, and hemoglobin, into the interior of
the implant, without damage or violation in the capsule surrounding it. This process
can cause harm to the patient as it leads to inflammatory responses and increase in
breast volume, often unilaterally, generating breast asymmetry, clinically confused
with breast pseudo-contracture, and a possible increase in the incidence of capsular
contracture, showing no difference between submuscular and subglandular implantation.
Changes are usually clinically noticeable after the fourth year of surgery, appearing
to be progressive.
The alteration evidenced in the material inside the two implants, which differ only
in terms of use, indicates the occurrence of the passage of organic materials through
the intact capsule, in a flow not yet reported in the literature, from the human body
to the inorganic implant.
1. Clínica Dr. Milton Daniel, Cirurgia Plástica, Curitiba, PR, Brazil
2. Faculdade Evangélica Mackenzie do Paraná, Medicina, Curitiba, PR, Brazil
3. Hospital do Trabalhador, Cirurgia Geral, Curitiba, PR, Brazil
Corresponding author: Lincoln Graça Neto Av. Visconde de Guarapuava, 4742, Batel, Curitiba, PR, Brazil. Zip Code: 80240-010
E-mail: lgracaneto@hotmail.com