Primary Breast Augmentation with Textured and Smooth Saline Implants: A Retrospective Review
A retrospective review was completed of all patients who had undergone primary bilateral breast augmentation with saline implants during the period from January 1, 1991, through December 31, 1998. These patients’ records were then evaluated for re-operation and the indications for returning to surgery.
A total of 1312 saline implants were placed in sub-pectoral pockets in 656 patients during the study period. Textured implants (n=908) were placed in 69% of patients, while smooth implants (n=404) were placed in 31% of patients. Re-operations occurred in 24% of patients. One of the most common indications for re-operation was implant deflation. This occurred in 4.9% of textured implants and in none of the smooth implants (p=.0066). Re-operative rates for implantation also include elective implant volume adjustment (5.9%), capsular contracture (5.2%), pocket revision (2.9%), and treatment for rippling (1.8%).
Re-operations in patients with primary saline augmentation were relatively frequent and included both elective indications such as size adjustment as well as the treatment of symptomatic problems such as deflation, capsular contracture, and rippling. Our study suggested that there is no difference between capsular contracture rates of textured versus smooth implants. However, a statistically significant difference in deflations was seen between textured and smooth saline implants. The potential benefit of using textured saline implants to reduce the capsular contracture rate may be negated through their higher implant deflation rates.
Since the current Food and Drug Administration (FDA) moratorium on silicone gel-filled implants, inflatable saline breast implants have been the only prostheses available for primary breast augmentation. The use of saline breast implants, however, has its own set of problems and complications often necessitating re-operation.1 Re-operations after primary breast augmentation are necessary for numerous reasons ranging from deflations, capsular contracture and rippling to adjustments of implant position and size. 1,2
Since the use of saline implants in our practice, we have noted a high incidence of re-operations, and in particular deflations associated with the use of textured saline breast implants. This observation led us to inquire about our experience with saline breast implants in primary breast augmentation. Our goal in this study was to determine the overall rate of re-operation when using saline implants in primary breast augmentation as well as to determine whether there was a significant difference between textured and smooth implants.
Patients and Methods
We accessed the patient database of the Charlotte Plastic Surgery Center in Charlotte, North Carolina. All patients from January 1, 1991, through December 31, 1998, who underwent primary breast augmentation with saline implants were reviewed. Any patient that had previous augmentation with gel implants or had implantation for breast reconstruction was excluded from the study. The total cohort in our study represented 656 patients with 1312 implants. The data was then analyzed per patient and per implant. We extracted from the the medical record the patient’s names, record number, date of initial augmentation, prosthesis type and lot number, size of implant and fill volume. Also recorded was the date of re-operation, indications for re-operation, and last follow-up visit. The patients’ average follow-up time and period to re-operation was determined. Rates for deflation and re-operation for capsular contracture along with other indications for re-operation were assessed. Finally, incidence density rate analysis was used to determine if the differences found in the study were statistically significant.
The Department of Statistics at the Carolinas Medical Center, Charlotte, North Carolina, assisted with data analysis. Statistical analysis was performed on a SAS software package (Cary, North Carolina). Indications for re-operation were evaluated using incidence density rate analysis. A p level < 0.05 was considered significant.
During the study, we found that 1312 prostheses had been placed. Of these, 908 were textured membrane implants and 404 were smooth membrane implants. (See Table I). All implants were placed in the sub-muscular position. The operative approach was periareolar in 446 patients, inframammary in 163 patients, and endoscopic transaxillary in 12 patients. Thirty-five patients had a mastopexy performed at the time of initial augmentation. The average time to follow-up was 46 weeks in the textured group and 21 weeks in the smooth group.
Re-operations were performed in 156 (24%) of the patients in our study. Textured implants accounted for 80 percent of these procedures. Overall, 28 percent (n=128) of patients with textured implants returned for a secondary procedure as opposed to 16 percent of smooth implant patients. When excluding the elective operations for increasing implant size, the textured implant group had a re-operation rate of 16% compared to 7.4% in the smooth implant group (see Table 2). The major indications for re-operation were deflation, contracture, rippling, and size change.
Forty-four re-operations were necessary for deflation in 40 patients. All re-operations for deflation were in the textured implant group. Four patients had two implant deflations. Considering all implants, we found a 3.4% deflation rate per implant placed, with a 4.9% deflation rate for the textured implants group alone (see Table 2). Of note, the average time before rupture was 200 weeks (see Graph 1). It was noted that 11% of the implants that ruptured had been filled below the manufacturer’s recommended fill level. The difference in deflation rate between the textured and smooth implants was statistically significant (p=0.0066).
Capsular contracture requiring capsulectomy or capsulotomy occurred equally between textured and smooth implants in our study. Although Baker classification of contracture was not well documented, the complaints of pain, firmness, or ability to see the implant were serious enough to proceed to re-operation (see Table 2). Textured implants required re-operation for contracture in 5.3% of patients. Similarly, smooth implants required re-operation for contracture in 4.95% of patients. This resulted in a 5.2% re-operation rate overall. The difference in re-operation rate for contracture between textured and smooth implant groups was not statistically significant.
All re-operations for rippling occurred in the textured implant cohort. Twelve (2.6%) out of 454 patients required re-operation for rippling and all had bilateral replacement of implants. Additionally, two of these patients had implants that were filled below the manufacturer’s recommended level (see Table 2).
Thirty-nine patients (78 implants) were revised to increase their size. These cases were considered elective re-operations in our study. This occurred in thirty-nine patients and accounted for 6% of the total augmentation group. These patients were operated on primarily by one surgeon in our group.
Other indications for re-operation were hematoma, pocket and scar revisions. Hematomas occurred in eight patients (0.01%). Two patients, (0.003%) had subsequent mastopexies. Pocket and scar revisions totaled 38 (2.9%) and were not statistically significant between the types of implants (see Table 2).
Our eight-year retrospective study illustrates a significant difference in re-operative rates for textured and smooth saline implants. In particular, a profound difference was found when comparing deflation rates between the two different surface types. All of the implant deflations in our study were in the textured implant group. This is in contrast to other studies that showed that textured and smooth implants had equal deflation rates or that the smooth saline implants had higher deflation rates than textured implants. 3-6 A previous review by Lantieri, et al, related deflation to under-filling of saline implants. 7 In our study, underfilling was found in only 11% of the implant deflations and was not found to be statistically significant. The overall deflation rate of 4.9% for the saline implants was comparable to the rates quoted in the literature. 2,5,8
Over twice as many textured implants had been used and the average follow-up period for the textured implants was much longer than of it’s saline counterpart. Using incidence density rate analysis, we found that if the deflation rates for smooth implants were equal to that of the textured implants and at least 7 smooth saline implants should have deflated during the eight-year period; however; there were none noted. The power of the study is affected by the amount of textured implants used when compared to smooth implants. In addition, the shorter follow-up could have contributed to the number of smooth implant deflation disclosed. Despite these study imperfections, our clinical observation confirmed the statistically significant greater rupture rate in textured saline implants.
Other studies have looked at the capsular contracture rate in saline implants comparing textured and smooth implants. There have been reports ranging from a markedly lower contracture rate with textured implants to an equal rate of contracture between the two types of implants. 2,9 Those studies did not specifically address saline implants in the submuscular position. Our study did not grade capsular contracture. It is assumed that a Grade III capsular contracture or higher is present if it mitigates a re-operation. Although a statistically significant rate of capsular contracture does not exist in our study between textured and smooth implants, we cannot conclude if there is a difference due to the imperfections mentioned in our documentation.
All patients in our study that required re-operation for rippling had textured saline implants. This is consistent with our observation that rippling is more common in patients with textured implants. 5,9 Additionally, in many other patients with textured implants, there were complaints of rippling but no further procedures were performed for correction.
One drawback to note in this study is that, in general, patients undergoing breast augmentation do not have a long follow-up period. It is assumed that if the patient did have a deflation, they would return to our care for replacement of the implant. This should hold true for the other indications for re-operation as well, in the ideal world. Traditionally, this population is younger, more price sensitive, and likely transient with regards follow up. Additionally, there is no reason to believe that patients with smooth implants would follow up with our physicians at a lower rate than those with textured implants.
Our study focused on those patients undergoing primary breast augmentation with interest in the deflation rate between textured and saline. Textured implants deflations occurred at a significantly greater rate than smooth-walled implants. In addition, our study suggests that there is no difference in the capsular contracture rate between either style of implant surface.
In our study, patients with textured saline implants have a higher overall rate of re-operation than patients with smooth-walled saline implants. A major indication for re-operation is implant deflation. These deflations occurred only in the textured implant group. The difference in the rate of re-operations for capsular contracture is not statistically significant between the patients with textured implants and those with smooth implants which supports other studies. 2,5,8,10 As seen in our study, the potential benefit, if any, of using textured implants to decrease the capsular contracture rate may be negated through the higher deflation rates seen with textured saline implants.
Peter J. Capizzi, M.D.
Charlotte Plastic Surgery Center, P.A.
16455 Statesville Road
Huntersville, NC 28078
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