Coleman 1991 - BJPS - Textured or Smooth

Summary

This research article reports on a prospective, randomized, controlled trial conducted by Coleman, Foo, and Sharpe to investigate whether textured silicone breast implants reduce the incidence of capsular contracture compared to smooth silicone implants in breast augmentation surgery.

Introduction:

• Capsular contracture is a common complication after breast augmentation, occurring when the scar tissue capsule that naturally forms around the implant tightens and squeezes the implant. This can cause pain, firmness, and distort the shape of the breast.

• Many modifications to breast implants have aimed to reduce capsular contracture, including textured surfaces instead of smooth. But high quality evidence comparing textured and smooth silicone implants is lacking.

• Most studies are retrospective, with methodological flaws like lack of blinding, short follow-up, and incomplete follow-up. Better designed prospective studies are needed.

Methods:

• 53 women undergoing primary breast augmentation were recruited.

• Patients were randomized to receive either textured surface silicone implants (Mentor Siltex) or identical smooth surface silicone implants.

• At surgery, implant type was not recorded to maintain blinding. Patients were followed up after 12 months.

• 3 blinded observers used Baker's classification to grade capsular contracture from 1 (none) to 4 (severe).

• A difference in incidence of Baker grade 3/4 contracture of 30% vs 10% was defined as clinically significant.

• Statistical analysis used chi-square test with Yates correction.

Results:

• 50 patients (100 breasts) completed 12 month follow-up (94% retention).

• Total Baker 3/4 contracture incidence was 32%. Smooth implants had a 28/48 (58%) incidence vs textured implants 4/52 (8%).

• This difference was statistically significant (p<0.0001) suggesting textured implants reduce capsular contracture.

Discussion:

• Study design appears reliable with consecutive patients, randomization, high retention, blinding, and panel of observers.

• 58% contracture rate with smooth implants is higher than some reports but comparable to other properly controlled trials.

• 12 months follow-up is appropriate as most contractures happen in first year.

• Baker scale is subjective but best tool currently available. High observer agreement supports its use.

• Results clearly show textured implants significantly reduce capsular contracture compared to smooth.

• Difference was unexpected but methodological flaws unlikely given careful trial design.

• Justifies use of more expensive textured implants to reduce complications.

• Confirms it is possible to conduct well-designed studies in cosmetic surgery. Very few proper controlled trials exist on causes and prevention of capsular contracture.

• Mechanism for textured implants reducing contracture is unknown. Further studies needed.

Conclusion:

This randomized controlled trial provides strong evidence that textured silicone breast implants significantly reduce capsular contracture compared to smooth silicone implants for breast augmentation.