Thursday, February 7, 2019

An UPDATE to Breast Implant Safety - by Guest Blogger David A. Lickstein, MD FACS

David Lickstein, MD FACS wrote a guest blog post in May 2017 in response to a New York Times article regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Due to the recent headlines on this topic and more patient concerns, I reached out to Dr. Lickstein and asked him to write an updated guest post on the topic.                                                                                                               

David A. Lickstein, MD FACS
Board Certified Plastic Surgeon

Recent headlines regarding the denial of the EU safety certificate and the resultant suspension of the sale in Europe of textured Allergan breast implants have renewed concerns of many patients here in the U.S. with breast implants.  The action is related to ongoing concerns regarding the association between the textured implant surface and a rare type of lymphoma (ALCL) as well as the request for further study of the topic. Implants with smooth surfaces remain available in Europe.  Both smooth and textured surfaces are available for use in the United States.  

Recent studies have implicated the role of biofilm and prolonged low-grade inflammation.  This may also be related to friction or trauma from the rough implant surface on the surrounding tissue.  The irregular covering of textured implants equates to a much greater surface area on the implant that may allow for more ingrowth of bacteria than a smooth shell.   Although not all cases are in patients with confirmed implants types or history, all cases to date in which implant type can be verified are in patients with a history of exposure to textured implants.   Of existing implants, the Allergan textured surface is the most aggressive and has more reported cases than other manufacturers.

In the United States, the latest FDA update was issued in August 2018.  414 case reports of ALCL and 9 deaths have been noted involving different implant types.  The risk of developing ALCL is now estimated to be between 1:3817 and 1:30000.  Cases are typically noted 7-8 years after implantation and the presenting symptom is most often a seroma, or fluid collection around the implant.  Although registries have been established, reporting remains inconsistent, and the numbers may change in the future.  

At present, the FDA has not recommended exchange or removal of implants for asymptomatic patients.  While many women may feel less anxiety after having their textured implant exchanged for a smooth one, there is no data to confirm that this procedure lowers the risk of ALCL moving forward.  Given the late onset of symptoms, women are advised to continue, at a minimum, yearly follow up exams, and be cognizant of any changes to their breasts that should prompt immediate evaluation.

Additionally, the increased use of social media and ability for patients to connect on these platforms has led to an increase in women that present to plastic surgeons for evaluation of systemic symptoms that the attribute to their breast implants (breast implant illness – BII).  These are nonspecific symptoms and vary greatly from patient to patient.  They may include fatigue, pain, hair loss, rash, anxiety, malaise, headaches, sleep changes, depression, neurologic symptoms or hormonal issues.  They have been reported with all types of implants, regardless of fill or shell.  BII is not a specific medical diagnosis and patients may be frustrated because there is no simple test to confirm the relationship between their implants and their symptoms. 

Although prior studies did not indicate any link between silicone implants and systemic symptoms, illness, or laboratory abnormalities - all concerns must be taken seriously by physicians.  Further study is indicated and planned by plastic surgery societies.  For patients who feel affected, there is no data to confirm improvement in symptoms after removal.  Most information shared on the internet and via social media remains anecdotal.  Still, a lack of evidence at present to support a link does not suggest that certain patients who are suffering may not benefit from removal of their implants.

It is recommended that women with concerns regarding ALCL or BII see a board certified plastic surgeon with experience in all types of implant surgery – augmentation, reconstruction, revision, and explantation.  It is also advised that patients with symptoms carefully consider the proliferation of informational seminars and surgeons marketing themselves as “explantation specialists”.  It is also recommended that patients be comfortable with the provider, and that this is not simply a marketing initiative aimed at “selling” expensive “cash only” procedures to groups of fearful women.   A surgeon with experience in all types of breast surgery can discuss the options available after explantation – replacement, mastopexy (breast lift), fat grafting, etc.

 The surgeon should have an understanding of the indications for en bloc capsulectomy (complete removal of the scar around the implant).  Simple explantation alone may not be appropriate to allay fear and treat their condition.  Full capsulectomy, however, requires a large incision and has the additional surgical risks of injury to the muscle, skin, rib, or lung.   The operation may be quite difficult after mastectomy if the skin flaps over the implant are thin.  Experienced surgeons will listen, and be able to provide information and appropriate helpful recommendations.  They should be compassionate and honest about whether they feel symptoms can be improved.

Government hearings to review implant safety are scheduled this year in the US and abroad.  More information will be forthcoming.  At this time, all patients with breast implants in place should see a board certified plastic surgeon yearly – even if they have no new concerns.  Office visits allow for an appropriate physical exam, the exchange of up to date information, and the ability to answer any questions.  The FDA recommends MRI evaluation of implant integrity is recommended three years after implantation and every other year there after. Being healed and pleased with your results does not mean that there is no need for lifetime follow up.  

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Learn more about David A. Lickstein, MD FACS licksteinplasticsurgery.com




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