So What’s Wrong with Textured Implants? And Why is Allergan Withdrawing Them?
First a little lesson in history.
Breast augmentation is the most popular aesthetic surgery procedure in the Western World. Given its history, there is a vast amount of scientific literature devoted to the subject. I should know as I have contributed two comprehensive, most current and up to date book chapters to this subject for Plastic Surgeons. All this work is a testament to its pre-eminence in the field offering an array of differing opinions and philosophies. This is at least partly due to the use of implants and the controversy regarding their safety. Czerny, a German 19th century surgeon reported the first breast augmentation when he transferred a lipoma (lump of benign fat growth) from a patient’s back to the breast. Over the years many injectable, as well as implantable, materials have been used including shellac, beeswax, epoxy resin, petroleum jelly, Teflon, polyurethane and polyvinyl alcohol. The introduction of the silicone breast gel implant by Cronin and Gerow in 1962 revolutionised breast augmentation surgery.
Silicone or dimethylpolysiloxane was first developed during WWII as part of aircraft engineering. Its softness and inert nature made it the perfect prosthetic substrate for medicine. Silicone breast implants can be divided into five generations based on the shell thickness, texture and implant fill. So data from the early generations of implants indicated relatively high rates of capsular contractures with Silicone implants. This means that the capsule formed but the body around the implant becomes hard and distorted.
So now for a bit of technical information.
Biocell developed by McGhan Medical (owned by Allergan) recently withdrawn from the European markets and Siltex developed by Mentor. The textured implants have been implicated in development of a rare T-cell lymphoma. Biocell is composed of an irregular open pore textured surface with an average density of 3.1 pores/mm2 and an average pore size of 289 microns. These pores, created by a lost salt technique, develop through an adhesive effect. Although this is similar to polyurethane, there is no delamination. This shell characteristic has been used for both saline as well as silicone filled implants resulting in immobile yet soft implant feel and lower contracture rates. Siltex however, is a textured surface characterised by a pattern of nodules ranging in height (65-150 microns) as well as width (60-275 microns). These do not adhere to the surrounding tissues, and consequently they are mobile in the pocket and have resulted in lower contracture rates whether saline or silicone filled.
A recent publication of a paper in the Annals of Plastic Surgery journal by the respected authors and institution of MD Anderson has rekindled the debate. The major strength of this study is that it is the single largest study looking at complications associated with Silicone Breast implants. Coroneos and colleagues looked at the safety and efficacy of implants in 99,993 patients in the two largest companies, included were Allergan and Mentor. This is the single largest study by many folds. The outcome of this study is the first with significant power to identify risks of acquiring connective tissue disorders. They have highlighted the real issue of potential problems in relation to breast implants. They found that there was a significantly increased risk of acquiring Sjogrens syndrome, scleroderma, rheumatoid arthritis, still birth and one recorded case of melanoma. They also found that capsular contracture and rupture rates are higher with those who have silicone implants, 5.0% versus 2.8% saline (p < 0.001). This means that the findings are not incidental and have statistical significance.
The Summary of the findings:
|SLE||0.65% risk = 1.11X increased risk vs. general population||0.006% risk = 9X protective vs. general population|
|RA||0.35% risk = 5.96X increased risk vs. general population||0.008% risk = 7X protective vs. general population|
|Scleroderma||0.04% risk (but reported as 7X more likely vs. general population)||No reports|
|Sjogren’s||0.06% risk (but reported as 8X more likely vs. general population)||No reports|
|Breast Cancer||No difference in general population||No reports|
|Lung Cancer||9X protective vs. general population||No reports|
|Melanoma||0.08% risk (but reported as 3.71X more likely vs. general population)
? increased in sunbathing young breast augment patients.
It certainly has reopened the debate on this topic again amongst Plastic Surgery experts. We are currently compiling the next update on the topic of breast augmentation in one of the major Plastic Surgery reference textbooks and are taking this study into account.
Now for the cancer scare.
The first reported case of a patient with anaplastic T-cell lymphoma was by Keech in 1997. In America, The Food and Drug Administration (FDA) has been notified by the American Society of Plastic Surgeons (ASPS) of 414 device reports of BIA-ALCL, estimate to be under 1000 world wide. The current risk according to the FDA based on cited cases of BIA-ALCL with textured implants is a range of 1:3,817 to 1:30,000 and with this risk in mind the FDA does not recommend any changes in medical care and follow-up, particularly in asymptomatic patients. A recent systematic review by Leberfinger and colleagues identified 115 articles on BIA-ALCL involving 93 reported cases which have been identified in the literature. In Australia, spanning a 5 year period, there were 55 recorded cases of BIA-ALCL involving textured implants. There have been 4 related cases of death. Explantations (removal of the implant and capsule) included higher surface area of implants. Eleven patients had complications of either rupture, contracture or infection. All patients underwent total capsulectomy and resection of capsule. The most significant point here is that they were all textured implants and this seems to be the reason for Allergan’s withdraw of all textured implants and tissue expanders. The current recommendation involves analysing any new seromas for possibility of this.
So what should people do?
1) Find out what implant type you have.
2) Contact your surgeon; we routinely follow up our patients and contact them in any cases of notification. We do not use Allergan implants.
3) If you are considering implant surgery, do your research and make sure that you find a qualified specialist plastic surgeon and ask questions.
Good luck and wish you all a wonderful year ahead.
For information on the Breast Augmentation procedure, visit Click Here!