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ORIGINAL ARTICLE
Year : 2023 | Volume
: 31
| Issue : 1 | Page : 1-7
Evaluation of different breast implants for rupture and durability after implantation
Safvet ORS
SO-EP Aesthetic and Plastic Surgery Clinic, Kayseri, Turkey
Correspondence Address:
Dr. Safvet ORS
Hunat Mah, Nuh Naci Yazgan Caddesi No: 21, Kayseri 38050
Turkey
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/tjps.tjps_29_22
Aim: This study includes the evaluation of 84 implants removed after an average of 10 years from 42 patients who underwent augmentation mammoplasty and augmentation mastopexy at various centers over a 20-year period. Patients and Methods: Implants from patients who were all women aged between 28-60 years were evaluated after an average of 10 years following breast implantation. Preoperative physical examination, ultrasound examination and magnetic resonance imaging (MRI) were performed. Breast implants were removed from 42 patients for various reasons. The capsules and the free fluid removed with the implants underwent pathological and cytological evaluation. 84 implants that were removed were evaluated and scored for rupture, gel leakage, presence of air in the gel, changes in shell structure, and base deformities. Implants without any deformity were given a full score of 10, while score reduction was made according to various types of deformities seen in other implants. The average score of each implant brand was compared to other brands. Results: Rupture was observed in 23 of a total of 84 implants, while implant deformities such as gel leakage, air presence in the gel, decreased elasticity, base deformity and thinning of the shell were also present. Among all, 16 implants received a full score. The durability of the implants in the human body and the damage they received were classified according to their scores. Those with a score of eight and above were classified as high, those with a score between 6-8 were classified as medium, and those with a score of less than six were classified as implants with low endurance. Most of the implants evaluated here had low to medium endurance. The volume of one of the ruptured implants was 200 mL, while the rest ranged from 275-400 mL. Bilateral rupture was observed in one patient with a McGhanR implant, which had stayed in the human body the longest (15 years). Apart from this, all ruptures in other cases were unilateral. In some of the implants of EurosiliconeR(three implants), McGhanR(two implants), NatrellaR(one implant), RofilR(one implant) and PolytechR(one implant), it was observed that the implant shell was completely torn, fragmented and disintegrated, and the gel was diffused into the capsule. Shell decay was much higher especially in EurosiliconeR, RofilR and McGhanR brands. The durability of the implants was classified according to their scores. High endurance implants were those with a score of eight and higher: MentorR, SilimedR, MotivaR, and ArionR. Medium endurance implants were those with a score between 6-8: EurosiliconeR, PolytechR, McGhanR, and NatrellaR. Low endurance implants were those with a score of six and lower: RofilR and PipR. Conclusions: Occurrence of rupture and various complications increase in implants especially after 10 years. Often from certain brands, particularly the high-volume implants, rupture more easily in time. Close follow-up should be planned for patients who have had implants for more than 10 years, considering the duration, implant brand and volume.
Keywords: Augmentation mammoplasty, breast implant complications, breast implant, implant rupture, silicone
Breast augmentation with implants is among the most common plastic surgeries in the world. Although various fillers and fat injections can be used for breast augmentation, implant augmentation is still the safest method.[1],[2],[3],[4],[5] Most important criteria in implant selection are implant quality and durability. From time to time, news and reports of complications are spread about implants, generally of extravagant sizes.[6],[7] Many complications of breast implants such as seroma, infection, bleeding, capsule contracture, anaplastic large-cell lymphoma (ALCL), ptosis, deformity, and galactorrhea are reported.[8],[9],[10],[11],[12],[13],[14],[15],[16] Most of these complications occur as a biological response to the implant. However, complications such as implant-induced rupture and gel leakage are related to implant production, technology, and quality.[17],[18],[19],[20],[21],[22],[23] In previous studies, comparison of several implant brands for short- and long-term complications has been reported.[24],[25],[26],[27],[28],[29] Nevertheless, a detailed study comparing many implant brands is lacking in the literature.
In this study, breast implants of 10 different brands were removed for various reasons after 8–15 years (average 10 years) in the human body, and the status of the implants was compared by considering various parameters. The implant brands included in the study are Mentor®, Eurosilicone®, Pip® (Poly Implant Prothèse), Polytech®, McGhan®, Arion®, Rofil®, Silimed®, Motiva® and Natrella® (Allergan). We believe that this study reveals the potential risks in patients with long-term breast implants and guides in terms of which brands should be followed more closely and replaced when necessary.
Patients and MethodsFrom 2001 to 2021, a total of 84 breast implants were removed from 42 patients who had previously undergone augmentation mammaplasty and augmentation mastopexy. The mean age of the patients, who were all women, was 32.8 years (range, 28–60 years) and the mean body mass index was 22.1 kg/m2. Ethical approval of the retrospective clinical study was granted by the research ethics committee. Informed consent form was used for this study. All patients were in good general health with no comorbidities, while 10 patients were smokers. 8–15 years (mean 10 years) had elapsed since breast implant placement in the patients. A limited number of earlier and later cases were not included in this study.
Preoperative evaluation
Preoperative physical examination, ultrasound examination, and magnetic resonance imaging (MRI) were performed in the patients. According to MRI results, 20 of the 84 implants were reported to have intracapsular rupture, while three patients were diagnosed intraoperatively. Especially, most of the patients with implant rupture did not have any complaints. It was observed that capsule formation prevented deformity. Pain in ruptured implants was predominant in only two patients. Reasons for request for implant removal included replacement with larger prostheses (12 cases), pain and not wanting any prostheses (six cases), capsule contracture (five cases), deformity (seven cases), and breast ptosis (12 cases).
Surgical technique
All patients were operated under general anesthesia by the same surgeon. Breast implants were attempted to be removed together with the capsule. In patients who underwent capsulectomy, the process of separating the capsule from the normal tissue was started with a dissection from the anterior part of the implant (breast tissue base or pectoral muscle base) toward the posterior surface (chest wall surface). This was our choice as, in our experience, it was easier to dissect the capsule from the surrounding tissues with this technique. The removed prostheses were subpectoral in 26 cases and subglandular in 16 cases. The implants were immediately examined after removal, and the deformities were noted. In patients with capsule contraction and deformity who requested a larger implant, previous incisions were used, while in patients with ptosis who do not want any prostheses, superior pedicle augmentation mastopexy technique was used. In seven cases, the implants were moved from the subpectoral to the subglandular area. After the removal of the implant together with the capsule, an incision was made to the capsule and the implant was taken out. While capsulectomy was performed in 38 cases, only capsulotomy was performed in four cases who did not have sufficient thickness of breast tissue over the implant. The removed capsules and free fluid underwent pathological/cytological evaluation. The same brand implant was not used instead of the removed implants. The implants used were Mentor® and Motiva® brands. The number of breast implants removed was as follows: Mentor® (16), McGhan® (14), Eurosilicone® (14), Motiva® (6), Natrella® (6), Rofil® (6), Silimed® (6), Pip® (6), Polytech® (6), and Arion® (4).
After the new implants were placed, suction drains were placed in all patients and the subcutaneous tissue was closed with two layers of PDS (Polidioxanone, Doğsan™, Trabzon, Turkey) suture. None of the patients needed blood replacement. Postoperative corselet, antibiotics, and analgesics were used routinely in all patients. No serious complications were encountered in the early period.
Evaluation of implants
Eighty-four removed implants were evaluated and scored by two different clinicians based on rupture [Figure 1], gel leakage [Figure 2], air in the gel [Figure 3], changes in the shell structure [Figure 4]a, [Figure 4]b, [Figure 4]c, and deformities seen in the base [Figure 5]a, [Figure 5]b, [Figure 5]c.
Figure 1: Diffuse ruptured implant of Rofil brand and nonruptured implant with highly increased elasticity. 12-year postimplantation
Figure 2: (a) Although there is rupture of the left side implant, the thick capsule prevents deformity. (b) Implant of McGhan brand, thickening calcification is observed in the capsule due to gel leakage. 13-year postimplantation
Figure 3: (a) Implant of Arion brand. A single small air bubble is visible in the gel. (b) Multiple large air bubbles are observed in the implant of Mentor brand
Figure 4: (a-c) Eurosilicone, McGhan, and Natrella brand implants show thinning of the shell, increase in elasticity, and softening of the implant
Figure 5: (a-c) Irregularities in the shell structure at the base of the implants are observed in three different brands. 12-year postimplantation of the teflon-coated implant, irregularity at the base, and slight decay are observedScoring of implants
The scoring of the removed breast implants was made according to the scoring system developed by the authors. No previous study on scoring has been reported in the literature. Implants without any observable deformity were given 10 full points. Implants with linear ruptures in a single area were given five points [Figure 6], while implants with multiple ruptures and complete disruption of shell integrity were given zero points [Figure 1]. One point for implants with gel leakage; one point for small volume of air at one or two points within the implant; two points for large diffuse air within implant; two points for thinning, hardening, softening, or deformity of the shell structure; and two points for deformity or abrasion at the base [Figure 5]b and [Figure 5]c were deducted from 10 points, resulting in a net score for each implant. The average score of each brand was found by adding the scores of each implant and dividing it by the number of implants of the same brand. Scoring was done for individual implants, not for individual patients. The brands of the implants removed, implant status, obtained scores, duration of the implant in the human body, and their rupture rates are summarized in [Table 1].
Figure 6: A pair of implants of Mentor brand. One of the implants has linear rupture (9-year postimplantation)
Table 1: The brands of the implants, counts, implant status, scoring, shell thinning, duration of the implantation, and rupture ratesIn three patients, very prominent thickening of the capsule was observed in the exact center (the area corresponding to the implant filling site) bilaterally at the posterior of the implant [Figure 2]. In addition, a milder reaction was observed in the same area of the capsule in one patient (two implants). Pathological examination of eight capsules in a total of four patients was reported as foreign body reaction and calcification. The brands of these eight implants were Arion® (two implants), McGhan® (four implants), and Rofil® (two implants). The reaction in the capsule in these eight implants was evaluated to be due to gel leakage. For the evaluation of thinning, deformity, and elasticity in the shell, an unused implant of the same brand and the implant removed from the patient were placed side by side; the implant was compressed and evaluated by giving various shapes. Changes in elasticity were observed in a total of 20 implants. In particular, an increase in elasticity (softening of the shell) was observed in implants of McGhan®, Eurosilicone®, Natrella®, and Rofil® brands [Figure 4]a, [Figure 4]b, [Figure 4]c after removal. While there was no significant change in the elasticity of Mentor® and Arion® implants [Figure 3]a and [Figure 4]b, Pip®, Motiva®, and Silimed® implant shells were harder following removal. While small volumes of air bubbles were seen in a single area in the gel in five implants, large air bubbles were observed in more than one area in 10 implants [Figure 3]a and [Figure 3]b. Base deformity was observed in a total of 10 implants. Deformity and jagged appearance at the base were more common in teflon-coated (Silimed®) implants [Figure 5]b. Shell thinning was observed in a total of 10 implants, which was more pronounced in Eurosilicone®, McGhan®, Rofil®, and Natrella® brands [Figure 4]a, [Figure 4]b, [Figure 4]c. The number of implants with a full score was 16 out of 84 implants. The endurance of implants in the human body was classified according to their scores. Those with a score of eight and higher were classified as high endurance implants, those with a score between 6 and 8 were classified as medium, and those with less than six points were classified as implants with low endurance.
ResultsWhile 74 of the removed implants were round, six of them were anatomical, four of them were coated with polyurethane, and all implants were gel-filled. The volume of one of the ruptured implants was 200 mL, while the rest ranged from 275 to 400 mL. Bilateral rupture was observed in one patient with a McGhan® implant, which had stayed in the human body the longest (15 years). In this patient, a linear ruptured implant on the right and a diffuse fragmented implant on the left were encountered. Apart from this, all ruptures in other cases were unilateral. In some of the implants of Eurosilicone® (three implants), McGhan® (two implants), Natrella® (one implant), Rofil® (one implant), and Polytech® (one implant), it was observed that the implant shell was completely torn, fragmented, and disintegrated, and the gel was diffused into the capsule. Shell decay was much higher, especially in Eurosilicone®, Rofil®, and McGhan® brands. Although bilateral rupture was not present in Motiva® implants, there was a substantial amount of air in the gel in contrast to other implants [Figure 7]a. Not all implants were followed up after explantation. Only air-containing implants were followed. Interestingly, it was observed that the air in the implant disappeared 1–2 years after its removal from the body. The air in 12 out of 16 air-containing implants disappeared spontaneously [Figure 7]b. While there was no difference between subpectorally and subglandular placed implants, rupture was more common in implants with macrotexture surfaces.
Figure 7: An implant of Motiva brand with a chip. (a) There is ample air in the gel. (b) The air disappeared spontaneously two years after the removal of the implantThe durability of the implants was classified according to their scores.
High endurance implants were those with a score of eight and higher: Mentor®, Silimed®, Motiva®, and Arion®.
Medium endurance implants were those with a score between 6 and 8: Eurosilicone®, Polytech®, McGhan®, and Natrella®.
Low endurance implants were those with a score of six and lower: Rofil® and Pip®.
The mean scores of the implants were compared using the t-test. Values with P < 0.05 were considered statistically significant. There was no significant difference between Eurosilicone®, Polytech®, McGhan®, and Natrella® implants (P > 0.05). Similarly, no significant difference was found in the comparison of Mentor®, Silimed®, Motiva®, and Arion® brands (P > 0.05). The difference was significant when Mentor®, Silimed®, Motiva®, and Arion® brand implants were compared to Eurosilicone®, Polytech®, McGhan®, Natrella®, Rofil®, and Pip® implants (P < 0.05). On the other hand, the difference was significant when Eurosilicone®, Polytech®, McGhan®, and Natrella® implants were compared to Rofil® and Pip® brands (P < 0.05).
DiscussionThere is a very common perception among patients that breast implants should be replaced every 10 years. In recent years, many manufacturers have given their implants a 10-year warranty against manufacturing defects and rupture. Based on both patient and manufacturer behavior and scientific studies, a 10-year duration is a threshold time for implants. According to some researchers and our observations, occurrence of rupture and other complications significantly increase at the end of this period.[17],[18],[19],[20],[21],[23],[26],[27],[29],[30],[31],[32] It is now clear that a certain proportion of patients who have had breast implants may require an additional implant-related intervention throughout their lives. These may be due to simple slipping, ptosis, capsule contracture, or more serious issues including implant rupture. Although the overall rate of nonrupture complications is higher, there is more misdoubt over implant rupture.[19],[31],[32],[33]
Many studies report implant rupture rates in the first 5 years and beyond following breast implant placement. While rupture rate is very low in the first 5 years, it rises significantly as the duration extends and exceeds 10 years.[30],[31],[32] According to studies on breast implants, one of the most important data on implant quality is rupture rate.[19] In these studies, generally, implants of the same brand are followed for a certain period of time and comparison among the same brand is performed at the end of this period. In some studies, two or three different brands of implants or two different implants produced by the same company were compared.[20],[23],[28],[29],[30],[31] Unlike previous studies, our study focused on both rupture and changes due to aging of the implant over time.
The durability of the implants varies according to different brands. As the technology develops, implant surfaces, durability period, aging rate, gel content, and texture structure change and improve.[20] For example, the use of macrotexture implants has recently been restricted due to capsule complications (ALCL). Although the biocompatibility of breast implants is excellent, it is ultimately a foreign object for the body. The question is do implants really wear out in the body and the outer shell of the implant decay over time? Aging and decay are two issues that are not extensively discussed in the literature. Breast implants, which are an artificial product, will wear out in the human body sooner or later. Minor damage to the implants may be a precursor of rupture. For this reason, we believe that our scoring system is important. Previous studies report a varying rupture rate of 1%–30% depending on the implant brand, duration in the body, its anatomical shape and texture, and the volume of the implant.[18],[19],[32],[33],[34] It has been demonstrated both in previous studies and in our study that the aging and complication rates of implants are directly proportional to their duration in the human body.[18],[19],[32],[33],[34] Some researchers reported that the rupture rate was much higher in round macrotexture implants.[34] Similarly, in our study, rupture rate was found to be higher in macrotexture implants. In macrotexture implants, the shell is damaged more easily due to friction. For this reason, it is both easily ruptured, and its capsules develop differently.
When breast implant rupture is mentioned, it is generally understood that there is a linear tear in the membrane and the implant structure is not completely destroyed since this is usually seen in the patients that were operated on [Figure 6]. In some brands of breast implants, it has been observed that the integrity of the implant is impaired as a result of decay in the shell, especially after 10 years. Unlike the classical rupture, this can actually be considered as the loss of shell properties due to decay [Figure 1] and [Figure 8]. It has been observed that this decay is more prominent in Eurosilicone, Rofil, and McGhan implants. When Eurosilicone, Rofil, McGhan, Polytech, and Natrella brand implants are roughly examined with the naked eye, it can be seen that the shell structures are very similar to each other. In addition, when hand-pressed, the shell of these brands of implants feels very thin and highly elastic. In this study, we observed that the implant shell becomes a very thin fragile membrane in 15 year implant, the capsule on it becomes very hard due to calcification, and the implant shell and the capsule nearly become integrated. The fragile shell can easily rupture when separating the capsule from these implants. However, this is not a frequent change in implants under 10 years where the capsule can be easily separated from the membrane. According to Hölmich et al., even with modern implants, the rate of rupture is at least 15% after 3–10 years following implantation.[32] This reported rate is indeed very intimidating.
Even minimal decay and thinning at the base of the implant in the long term can be revealed with careful examination. When we examined the ruptured implants, the volume of only one of the implants was below 200 mL, while the volume of the remaining 22 implants ranged between 275–400 mL. As the surface area becomes larger, the durability of the breast implant worsens. Therefore, it can be concluded that as the implant volume increases, the rate of rupture and deformity becomes higher. According to our study, when breast implants were examined in general, perfectly smooth implants (n = 16) only consisted 19% of the total implants. This suggests that the implants are damaged to a certain extend over time. Partial or complete rupture was observed in 23 out of 84 implants (rupture rate = 27.38%). In almost every brand, the rupture rate increases significantly over the years. During the preoperative physical examination, we suspected rupture in only eight out of 23 implants. In implants that exceed 10 years, the capsule integrates with the implant shell and provides support as if it had replaced the implant shell. Therefore, even if there is a rupture, the deterioration in the shape of the implant is minimal, and in these cases, the rupture can be overlooked in physical examination [Figure 2]a, [Figure 9]a and [Figure 2]b. Therefore, we suggest that patients with implants over 10 years should be followed more closely and the possibility of rupture should be considered even when the patients are asymptomatic.
Figure 9: (a) An implant of McGhan brand. The rupture did not cause deformity in the patient. (b) An implant of Eurosilicone brand. The rupture did not cause deformity in the patientMentor, Arion, Silimed, and Motiva brand implants scored above eight, while the remaining six different brand implants scored between 5.33 and 6.50. Especially in the past 10–20 years, these six brands have been extensively used. Although the use of some of the brands classified into low and medium endurance implants according to our study is prohibited or limited, there are still many patients carrying these implants. Undoubtedly, all brands of implants should be followed closely; nevertheless, brands with a score between 6 and 8 according to this study are recommended to be more closely followed up, while brands with a score below six should immediately be removed if possible.
ConclusionWe report that the rate of rupture and other complications increases after 10 years following implantation. High-volume implants, especially Eurosilicone, Polytech, McGhan, Natrella, Rofil, and Pip brands, seem to rupture more easily over time. Close follow-up should be planned for patients who have had implants for more than 10 years, taking into account the duration, implant brand, and implant volume.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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