Aesth Plast Surg (2008) 32:432–441 DOI 10.1007/s00266-008-9138-6

ORIGINAL ARTICLE

Filling of Adjustable Breast Implants Beyond the Manufacturer’s Recommended Fill Volume

H. BeckerH. CarlisleJ. Kay

Received: 28 February 2007 / Accepted: 26 March 2007 / Published online: 8 April 2008 © Springer Science+Business Media, LLC 2008

Abstract

Background Adjustable breast implants are widely used for both reconstructive and cosmetic breast surgery. They provide unique postoperative versatility and allow for more effective management of numerous conditions that would otherwise require surgical intervention. Findings have shown that in a clinical setting, it often is necessary to overexpand saline implants beyond the manufacturer’s recommended fill volumes for positive results and optimal patient satisfaction. The authors investigated their breast- augmentation patients, comparing implants expanded beyond the manufacturer’s fill volume with implants that remained within the recommended parameters.

Methods A total of 138 patients (270 implants) undergoing breast augmentation mammoplasty with Smooth Round Spectrum implants were evaluated postoperatively. To determine the effects of overexpansion, the incidence of leakage was assessed as well as the possibility of increased firmness. Patients completed a satisfaction questionnaire. Results The findings showed no evidence of increased leakage with implants expanded beyond recommended fill volumes, and 97% of the patients reported a perfect score for satisfaction ratings. Of the 270 implants evaluated in the study, only 7 were given a less than perfect score. Conclusions By exceeding the recommended fill volume, the authors were able to use the implant to its maximal potential, with increased patient satisfaction. The authors were able to correct problems and avoid complications that could not have been resolved without deviating from the manufacturer’s recommended fill volumes. Nonvalidated

H. Becker (®)H. CarlisleJ. Kay

670 Glades Rd., Suite 220, Boca Raton, FL 33431, USA

restrictions on fill volumes severely limit the efficacy of adjustable implants.

Keywords Adjustable breast implants Breast augmentation mammaplasty Recommended fill volume -

Smooth Round Spectrum implants

Adjustable breast implants are widely used, for both reconstructive and cosmetic breast surgery. Each implant size has a recommended minimum volume, a temporary overexpansion volume, and a final volume. The manufacturer’s recommended fill ranges have been determined not by clinical use, but rather by placing implants on a flat surface and progressively filling them until wrinkling is minimal, then filling them further until scalloping occurred. These volumes represent the minimal and maximal recommended fill volumes. Clinically, however, it has been noted that a wider fill- volume range can and has been used successfully [1].

Often, we have been faced with situations in which it was clinically necessary to overexpand an adjustable breast implant beyond the manufacturer’s recommended fill volume. The only other alternative was reoperation and replacement with another implant. An example of this can be seen in patients with asymmetry or previous scarring.

Patients undergoing augmentation with adjustable implants commonly request use of a larger size, often beyond the manufacturer’s recommended fill volume. Currently, this happens often enough that all patients receiving adjustable implants must sign a consent form acknowledging that they have been advised about the effect of implant overexpansion, including the fact that increased leakage has not yet been determined.

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According to Richard Dowden [2, 3], implants with lower levels of fill volume are more prone to wrinkling. As a result, the implant has a shorter life span because of the stresses induced by fold floor failure. Thus, it is essential to achieve the “least wrinkled” fill volume by filling the implant to its optimal level. However, the limits set by the manufacturers are constrained by the Food and Drug Administration (FDA). Therefore, to provide patients with optimal satisfaction, it often is necessary for saline implants to be filled beyond the manufacturer’s recommended limits. When given the ability to select the volume postoperatively, patients most often choose higher fill levels.

According to a study by Greenwald, Moloye, Ondrovic, and Lee [4] at the University of South Florida in Tampa, Florida, saline-filled breast implants can be safely filled far beyond manufacturers’ recommendations with regard to the mechanical properties of the silastic polymer implant shell. In addition to the clinical judgment required to avoid hardness due to overfill, these researchers have recommended repeating this study using an in vivo incubation method to determine how overfill will affect implant shells over time in the harsh milieu of a biologic environment [ 1]. Therefore, we decided to investigate our breast augmentation patients receiving Spectrum implants, comparing the implants expanded beyond the manufacturer’s fill volume with those implants that remained within the recommended parameters.

Methods

A total of 138 patients undergoing breast augmentation mammoplasty with Smooth Round Spectrum implants (Mentor Corporation, Goleta, California) were evaluated postoperatively. Because not all patients received implants on both sides, only 270 total implants were evaluated in the study. To determine the effects of overexpansion, the incidence of leakage was assessed as well as the possibility of causing increased firmness of the breast implant.

The surgeon assessed patients to observe the effects firsthand. A questionnaire was submitted to patients, inquiring as to their satisfaction with their breast implants and their perceived softness of the breast and whether they experienced bothersome wrinkling.

Surgical Technique

All patients in the study underwent breast augmentation with Smooth Round Spectrum implants ranging in size from 175 to 575 ml. The implants were placed in the submuscular position and usually slightly underfilled at the time of the surgery. The microinjection domes were either buried subcutaneously and removed several months later or exteriorized and removed after 5 to 10 days.

Patients were offered the opportunity to participate in decision making with regard to their final implant size. In certain situations, if deemed necessary, the surgeon chose to temporarily overexpand the implant. These situations included cases of implants positioned too high, in which case an added degree of ptosis was desired or it was necessary to modify the size due to prior scarring (i.e., tubular breast deformity or previous capsular contracture).

Results

The graphs in Fig. 1 illustrate patient data from breast augmentation mammoplasty with Smooth Round Spectrum implants. Each graph represents an implant size ranging from 175 to 575 ml. The initial volume of the implant at the time of surgery is displayed, as well as final volume at the time of injection port removal. When applicable, the highest temporary volume also is displayed. The top of each graph records the range for the manufacturer’s recommended fill volumes, illustrated with a lighter horizontal bar on the graph.

Follow-up periods ranged from 6 months to 6.3 years. The complications included one leakage, one capsular contracture requiring reoperation, and two cases of fill tube problems requiring reoperation.

Patient Satisfaction Ratings

Patients were asked to rate their satisfaction with their implants according to the following three criteria:

  •  Results obtained: 3 (good), 2 (average), 1 (less than average)

  •  Breast softness: 3 (normal or softer), 2 (acceptable), 1 (hard)

  •  Implant ripples: 3 (none visible), 2 (acceptable), 1 (bothersome).

According to these criteria, a perfect score would be 9, which 97% of patients reported as their score for satisfaction. Of the 270 total implants evaluated in the study, only 7 were given a less than perfect score. Details of the ratings for the seven implants with less than perfect scores are shown in Fig. 2.

Discussion

Adjustable implants are available in single-lumen spectrum and double-lumen gel/saline. Manufacturers have certain recommended fill volumes, which reflect their in-house testing. According to Mentor Corporation, the maximal volume for Spectrum was determined by filling the device almost to the appearance of scalloping. The volume of the implant then was reduced until rippling appeared, which represented the minimal fill volume. Table 1 presents the

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Fig. 1 Patient data by implant size from breast augmentation mammoplasty with Smooth Round Spectrum implants

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manufacturer’s recommended fill volumes for its Smooth Round Spectrum implant.

In a clinical setting, it often is necessary to work beyond the manufacturer’s recommended limits. For example, in

some augmentation patients, even if implants have been filled to the optimum recommended fill volume, rippling sometimes occurs. This rippling often is corrected by overfilling the implant.

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Fig. 1 continued

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Nig. 2 Nonperfect patient satisfaction details

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Table 1 Manufacturer’s recommended fill volumes for Smooth Round Spectrum® implants

Implant volume (ml)

Temporary minimum volume (ml)

Final maximum volume (ml)

125

105

150

175

150

210

225

190

270

275

230

330

325

275

390

375

320

450

425

360

510

475

405

570

525

450

630

575

490

690

Although the size of implants is accurately determined preoperatively by placing sizer implants in the patient’s bra, a large percentage of augmentation patients are not initially satisfied with the size of their implants. Patients initially feel they are too large. However, as time passes, as the implants settle, and as patients get used to their new size, they request further filling of the implant. Adjustable breast implants provide unique postoperative versatility. Implant adjustability allows for more effective management of numerous conditions that would otherwise require surgical intervention [1].

If the implant is filled to the maximum recommended fill volume and the patient requests further fluid, then instead of undergoing a secondary surgery to replace the implant, the patient invariably elects to overfill the implant despite

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Aesth Plast Surg (2008) 32:432–441   441

the possible risk of increased leakage and a firmer feel. To assess the reality of this situation, the incidence of leakage and increased firmness was assessed for each patient. As shown by the data, only one patient in this study complained of excessive firmness. This patient, in fact, had capsular contracture and was being overexpanded in an attempt to correct the condition.

With regard to leakage rate, there was no evidence of increased leakage. In fact, the rate was lower than that of regular saline implants with diaphragm valves. This lower leakage rate is attributed to less fold floor failure due to overfilling as well as to decreased valvular leakage due to superior quality of the spectrum valve over the diaphragm valve.

For the reconstruction patient, it often is necessary to place the implant underfilled so as not to compromise the circulation to the skin flaps. We also found it beneficial to place implants underfilled to decrease postoperative pain. This is particularly beneficial for patients undergoing augmentation mastopexy to prevent wound problems and possible nipple necrosis.

Often, it is necessary to overexpand implants to iron out irregularities, to alter implant position, or to treat impending capsular contracture. In the treatment of capsular contracture after release of the capsule, overexpansion and splinting of the capsule have been found to be effective in reducing recurrence of contracture.

In the treatment of breast implant problems, it is extremely beneficial in many instances to deviate from the manufacturer’s recommended fill volume, especially in the treatment of symmastia. It is important to avoid tension on the repair site in the healing phase. Therefore, it has been advocated to keep implants underfilled until repair has taken place. Subsequently, 2 to 3 weeks later, the implant can be filled to the desired volume.

In treatment of the breast cancer patient, deflation of the opposite breast implant is sometimes necessary during irradiation to allow the radiation beam access to the target area. Based on our clinical experience, it appears that the risks involved with reoperation to replace an implant far

exceed the possible risks of deviating from the manufacturer’s recommendations. It is not known at which point this risk becomes significant. As with the expiration dates on drugs, manufacturers are exceedingly cautious to protect themselves from lawsuits.

Conclusion

It is unfortunate that nonvalidated restrictions placed on fill volumes severely limit the efficacy of adjustable implants. In our patients, we were able to correct problems and avoid complications that could not have been resolved without deviating from the manufacturer’s recommended fill volumes.

Our clinical data show that the fill volume in our patients often exceeds the manufacturer’s recommended fill volume. By taking this approach, we have been able to use the implant to its maximal potential, with increased patient satisfaction. It should be noted that the one leakage in this series occurred with an underfilled implant. Patient satisfaction results were high, with 97% of the patients reporting a perfect rating.

This study shows that implants filled beyond the manufacturer’s recommended fill volumes did not cause unnecessary firmness and showed no evidence of increased leakage over the study period.

References

  1. Becker H (2000) Adjustable breast implants provide postoperative versatility. Aesth Surg J 20:332–334

  2. Dowden R (2001) Saline breast implant fill issues. Clin Plast Surg 28:445–450

  3. Dowden R (1999) Breast implant overfill, optimal fill, and the standard of care. Plast Reconstr Surg 104:1185–1186

  4. Greenwald D, Moloye O, Ondrovic L, Lee W (2006) Mechanical and sensory testing of overfilled breast implants. Aesth Surg J 26:29–34

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Plastic Surgery - Dr. Hilton Becker, MD

Breast Augmentation, Breast Lifts, Facelifts, Breast Reconstruction, Cosmetic surgery
670 Glages Road, Suite 220, Boca Raton, Florida, 33431