Jonathan Hall, MD

BIA-ALCL and SIentra Implants

 

On July 24, 2019 The FDA released a safety communication to update the current understanding of BIA-ALCL and called for the voluntary recall of the higher risk devices.  This referred to the more aggressively textured Allergan BIOCELL  implants.  This recall did not include the textured devices from Sientra or Mentor

 

The FDA has been made aware of 573 cases worldwide of Breast implant associated anaplastic large cell lymphoma (BIA-ALCL). This is a little lower than previously reported because some cases had been reported more than once and the FDA has reviewed each and removed duplicates. Where the manufacturer was listed the FDA reports that 90.5% of the world cases involved an Allergan implant, 7.1% a Mentor implant and 1% a Sientra implant.

         So this is thought to be most common with the more aggressively textured devices (Allergan BIOCELL texture) and significantly less common with the less aggressively textured implants (Mentor and Sientra)

     Researchers in Australia and New Zealand where more textured implants have been used for a longer period of time report a 1:3,345 risk with Allergan BIOCELL and a 1: 86,029 risk with Mentor SILTEX texture.

 

Even with Allergan BIOCELL the risk is low enough that the FDA is not recommending the routine removal of these implants unless a patient is having symptoms.

 

The most common symptom is a late ( more than one year after surgery) collection of fluid around the implant, called a seroma.  This would show up as swelling.  But symptoms may also include pain, a lump in the breast or lymph node in the armpit, rash, fever, weight loss or unexpected changed in the breast shape, including asymmetry.

 

If you do notice any suspicious changes you should make an appointment to see your plastic surgeon. He or She will perform and evaluation and order the appropriate tests to determine if any treatment is indicated.  This typically involves having some of the fluid removed and sending it to be tested for a biologic marker called CD30.

 

Women who develop BIA-ALCL are usually cured by removing the implant and the scar tissue (breast implant capsule) surrounding it. Some patients may require additional treatment such as radiation or chemotherapy.

 

The use of texture with breast implants is controversial.  5% of breast implants used in the US have texture, which  can decrease shifting of an implant and reduce the need for additional surgery. 

 

     At the recent Breast Surgery Symposium in Atlanta in 2019 some surgeons have stopped using texture entirely.  But many surgeons are still using the less aggressively textured implants such as Mentor or Sientra after careful discussion with their patients because there is a risk of reoperation with smooth implants which may be less stable in patients whose breasts may be more prone to malposition.

It is difficult to give you a personal opinion without a formal visit in the office.  But Scars typically become thicker and redder for 6 weeks after surgery and then begin to fade and improve for 2 years or longe. .  I have my patients use micropore tape for the first 6 weeks with aquaphor being used on any open areas, but once everything is healed I recommend that they start silicone applied topically twice a day, such as Pro-sil.( available online).   Silicone strips or shapes can also  be used but involve more fussing around because you have to remove them for showers and exercise and then replace them each time.  It the scars continue to thicken and/or fail to improve slowly over the next 6-12 months despite using the silicone, then you doctor may suggest that he perform injections of a steroid directly into the scar, called Kenalog.  And don't get any sun on scars that are red, they can turn brown ("post inflammatory hyperpigmentation")

Good luck and I hope this helps.

There are many different factors to consider when sizing an implant.  You want to be full enough to meet your goals in and out of clothing.  Many patients will wish they had gone larger after they get used to a particular size.  But as the implant becomes larger and heavier there can be more "stretch" issues from the weight of the implant.  Think back to any friends that had large breasts when they were younger- they have drooped by now.  Some people say that a "large" implant is anything bigger than 350.  It would not be unusual to use a 400 or 425 in some patients in my practice.  But the point is made that as implants get larger the risk of stretching issues increases.  

The nipple to fold distance on stretch is one of the most important measurements: if it is 7 than an 11 cm base implant, 8, a 12 cm base implant and 9, a 13 cm base implant.  But heavier implants will cause this distance to stretch and increase.  The base width of your breast is most important only in that if you go wider than the base width of your breast it can start to look overly round, like an implant, a look that is undesirable by many if not most of my patients.  But going smaller than the base width is fine.  The implants only reliably  increase the volume of your breast, and if the implant is smaller than the base width it does not tend to appear overly round.  By the way, the ideal implants are measured a little differently in width because they are shaped to sit on a curved surface like your chest wall, not on a table.  You need to add 3 mm to the listed width of an ideal implant to match the measurements of a standard implant.  They need to be undersized a little bit to look natural.

So don't get hung up on the base width of your breasts, it is just one factor and only really important to not exceed.  

I find it helpful to have my patients try in sizers such as the Mentor sizing system in the office to get an idea of how the new breasts will look and feel in clothing.  The range of sizers is selected based on your breast measurements.




I hope this helps!

This is a great question and you have to weigh the tradeoffs for yourself.  All implants will fail eventually.  ALL IMPLANTS.     When a saline filled implant fails, it gets visibly smaller.  You don't see an external change with silicone implants so the rupture is "silent".  Over many years that silicone gel from a ruptured implant can irritate the surrounding tissues.  The risk of rupture in the 8 year data shows: Allergan gel 7.4 %, Mentor gel 13.6 % and Sientra Gel 7.2 % vs Ideal implant of 2.1%.  The rupture rate increases with time. You mention the newness of the Ideal implant company and that is a concern.  But you can get an enhanced warranty for an additional 169$ for the first year and renew it annually FOR YOUR LIFETIME for $79 each year.  This warranty is from an outside insurance company, Liberty Mutual.  Actuaries are very smart ( full disclosure: my son is an actuary for Liberty Mutual) and that means that they think that they are going to make money selling you this warranty.  So a vote of confidence from really smart people that this implant doesn't have many problems.  No other implant company lets you get a lifetime warranty.




You mention sloshing but this doesn't happen with the ideal implant, only with the traditional saline implant.  Hold both in your doctors office and shake them for yourself.  They are not colder in the winter because they are inside your body, I haven't heard of mold growth in an Ideal implant so I am curious with that comment- there have been reports in the past where doctors took it upon themselves to put something other than sterile saline into a traditional saline implant but I have not seen this happen for many years- mold can't grow in sterile saline.

Ideal had one lot with faulty valves that failed within a few days of implantation and the company immediately stopped production and fixed the problem,

I don't think they are significantly heavier than silicone of similar size but of course, don't use any implant that is too large for your frame.

The only downside to Ideal in my opinion:  They feel slightly firmer than silicone gel and need to be slightly undersized to look fully natural- But when sized properly these are not really factors and patients seem to love them.  So you have to decide the trade-offs for you of slightly softer feel to silicone vs worrying about silent rupture and how much you value these two things. 

I hope this helps in your decision





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I normally offer to re-pierce the earlobes that I repair.  I prefer to wait 3 months after the repair to allow the typical scars to begin to soften before piercing.  But anyone that is qualified to pierce an ear can do this for you after the appropriate time has passed.