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Breast Implant Update/BIOCELL® Implant Recall

Despite the closure of my office, I am still committed to the health and well-being of my patients.  Furthermore, my motto has always been,  “An educated patient is a happy patient”, and I have routinely kept my breast implant patients, cosmetic or reconstructive, informed of current information regarding breast implant safety.

As you have likely heard the past week, Allergan, a major manufacturer of breast implants, has voluntarily recalled BIOCELL® Textured Breast Implants and Tissue Expanders across their worldwide markets. Their global action follows a specific request from the U.S. Food and Drug Administration (FDA) for Allergan to voluntarily recall certain breast implants and tissue expanders from the market due to the risk of Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) (see previous updates on my website Blogs about this topic).  An explanation of this action can be found in layman’s terms in a New Beauty publication found here:

https://www.newbeauty.com/blog/dailybeauty/12832-allergan-recall-biocell-textured-breast-implants-explained/

For my breast implant patients, be aware that the majority (>90%) of all the implants I placed since starting my practice in 1987 were from the manufacturer Mentor, formerly Heyer Schulte. Some of these were Siltex textured implants; Siltex is a micro textured surface, not associated with BIA-ALCL. On occasion, typically for breast reconstruction, I have used Allergan (formerly McGhan and Cox-Uphoff) BIOCELL® macro textured implants. That was many years ago; note the average time frame for developing BIA-ALCL is 8 years, and I can assure my patients that I have not placed any Biocell implants in at least 10 or more years. The recall only applies to BIOCELL®  macro textured implants.

Importantly, for existing patients with BIOCELL® implants, the FDA statement re-emphasizes that they do not recommend the removal or replacement of textured breast implants in asymptomatic patients.The FDA’s recommendations, along with updated data on BIA-ALCL can be seen here:

https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

Allergan has also created the BIOCELL® Replacement Warranty for all patients currently implanted with BIOCELL® textured implants. The details of this effort can be found here:

https://www.surgery.org/sites/default/files/downloads/blasts/BIOCELL/BIOCELL2.pdf

My two specialty societies’ (ASPS and ASAPS)  latest information about BIA-ALCL  can be found here:

https://www.surgery.org/sites/default/files/BIA-ALCL-Talking-Points-6-24-19.pdf

Announcement

To All of My Patients and Friends in the Medical Community:
     I have been privileged to practice Plastic Surgery in Palm Beach County for 32 years. It is bittersweet that I inform you that I have closed my private practice at 1717 North Flagler Drive, West Palm Beach FL as of July 31, 2019 and hereafter I am restricting my practice. My husband retired over a year ago and has encouraged me to join him. I may chose to continue a limited practice if the right opportunity arises but as of now, I am “retired”.
     If you have been a patient and I have seen you in the last 5 years,  your records will be maintained until 5 years has lapsed since my last contact with you by Plastic Surgery of Palm Beach. You can request them by calling (561) 968-7111 and ask for Beth in Medical Records. For those of you who have breast implants dating back to 1987, I have maintained implant information on a computer program.  If you have misplaced your implant records and wish to obtain them, you may contact me preferably by email at jkrmd2019@gmail.com or by way of the office phone number (561) 833-6688 and leave a message on the voicemail which I will monitor periodically (NOTE: ATT was supposed to have transferred this line effective August 1st but after many hours on tech support, they have informed me this will not be activated until August 9th).
     I have enjoyed the privilege of providing what I hope has been exceptional Plastic Surgery service to you all during the past 32 years, having been awarded TOP DOCs the last 10 consecutive years. Many of you have become friends and I have cherished the opportunity you afforded me.  If you wish to contact me, see the information above.
Thank you and Warm Regards,
Jana K. Rasmussen, M.D., F.A.C.S.

Castle Connolly’s 2019 “TOP DOCS” Award

Once again, I am honored to be selected as Castle Connolly’s “Top Doctors” in Plastic Surgery for 2019, as published in the Gulfstream Media Group’s publications (Jupiter Magazine, The Palm Beacher, Boca Life). Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my 10th consecutive year for this selection and I am humbled to be recognized. My goal has always been to provide exceptional, individualized care to improve the health and well being of my patients, both reconstructive and cosmetic.

Castle Connolly’s 2018 “TOP DOCS” Award

Once again, I am honored to be selected as Castle Connolly’s “Top Doctors” in Plastic Surgery for 2018, as published in the Gulfstream Media Group’s publications (Jupiter Magazine, The Palm Beacher, Boca Life). Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my ninth consecutive year for this selection and I am humbled to be recognized. My goal has always been to provide exceptional, individualized care to improve the health and well being of my patients, both reconstructive and cosmetic.

Castle Connolly’s 2017 “Top Docs” Recognition

Once again, I am honored to be selected as Castle Connolly’s “Top Doctors” in Plastic Surgery for 2017, as published in the Gulfstream Media Group’s publications (Jupiter Magazine, The Palm Beacher). Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my eighth  consecutive year for this selection and I am humbled to be recognized. My goal has always been to provide exceptional, individualized care to improve the health and well being of my patients, both reconstructive and cosmetic.

FDA Update on Breast Implants

You may have heard recent media reports regarding breast implants and a rare form of cancer.  The FDA recently updated information regarding this disease (Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)). My specialty societies, The American Society of Plastic Surgery and the American Society for Aesthetic Plastic Surgery, are working closely with the FDA in monitoring the disease.

BIA-ALCL is not a breast cancer, but a rare and treatable T-cell lymphoma (a type of non-Hodgkins lymphoma) that involves the scar tissue around the implant (capsule) and usually develops as a fluid accumulation (non-traumatic seroma) around a breast implant.

The lifetime risk for this disease appears to be about 1 case for every 30,000 textured implants.  This equates to a 0.003 percent risk.  Thus far, there have been no confirmed cases of BIA-ALCL in women who have had only “smooth surface” breast implants.

The FDA is not recommending prophylactic removal of textured implants.  Rather, the FDA recommends, as do I, that every woman conduct regular self breast examination.  If you develop a seroma or a lump in your breast and do not have a doctor familiar with BIA-ALCL, contact my office right away.  I will comprehensively evaluate you and order the appropriate tests to determine if any treatment is indicated.

Women who develop BIA-ALCL can often be cured by simply removing the implant and the capsule around the implant (capsulectomy).  Some patients may require additional treatment (such as radiation or chemotherapy).  Following removal and capsulectomy, replacement with a smooth surface  implant may be an option.

For additional information about BIA-ALCL, I am happy to answer your questions or you may consult the following websites/links:  The American Society of Plastic Surgery website at  www.plasticsurgery.org/alcl or the FDA updated website at

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

 

KYBELLA® Now Available In Our Office!

KYBELLA® is the first and only injectable drug approved by the FDA (in 2015) “for the treatment of moderate to severe convexity or fullness associated with submental fat in adults”.  In lay terms, this drug improves the appearance and profile of moderate to severe fat below the chin, or “the double chin”.  KYBELLA® is deoxycholic acid (DOCA), a cytolytic drug, which, when injected into the tissue,  physically destroys the cell membrane causing lysis, i.e., permanent death to the fat cell so it can no longer store or accumulate fat, regardless if the origin of fat is genetic, weight gain or aging.

This is an office procedure involving multiple injections with a very tiny needle into the fatty area below the chin.  A topical anesthetic is applied beforehand for comfort.  Afterwards, an ice pack is placed to reduce swelling.  While normal activities may be resumed, because of the likelihood of swelling, social downtime for a few days is recommended.  The average treatment uses 2 to 4 vials, and the average patient requires 2-4 treatments at monthly intervals.  Once the result is achieved, further treatment is not necessary. This is a non-surgical alternative to liposuction in this area of the body!

The most common adverse reactions (>20%) include injection site edema/swelling, bruising/hematoma, pain, numbness, erythema/redness and induration/firmness.  Edema/swelling was reported as mild in 79.5%, moderate in 19%, and severe in 1.5%.  Ice packs, head elevation and time resolve this reaction.  Risks include frequent bruising/hematoma reported in 72%.  Marginal mandibular nerve injury resulting in an asymmetric smile was reported in 4%; spontaneous resolution occurred in a range of 1-298 days, median 44 days.  Dysphagia (difficulty swallowing) was reported in 2%; spontaneous resolution occurred in a range of 1-81 days, median 3 days.

Deoxycholic acid (DOCA) is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat.  Endogenous DOCA (that which normally circulates in the body) is a product of cholesterol metabolism and is excreted intact in the feces.  DOCA from KYBELLA® joins the endogenous bile acid pool in the liver circulation and is excreted along with the endogenous DOCA.

Before and after photos can be viewed at MyKybella.com .

Castle Connolly’s “Top Docs” 2016 Recognition

Once again, I am honored to be selected as Castle Connolly’s “Top Doctors” in Plastic Surgery for 2016, as published in the Gulfstream Media Group’s publications (Jupiter Magazine, The Palm Beacher). Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my seventh consecutive year for this selection and I am humbled to be recognized. My goal has always been to provide exceptional, individualized care to improve the health and well being of my patients, both reconstructive and cosmetic.

“Top Doctors” Recognition By Castle Connolly!

Once again, I am honored to be selected as Castle Connolly’s “Top Doctors” in Plastic Surgery for 2015, as published in the Gulfstream Media Group’s publications (Gold Coast Magazine, Jupiter Magazine, The Palm Beacher, Boca Life Magazine). Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my sixth consecutive year for this selection and I am humbled to be recognized. My goal has always been to provide exceptional, individualized care to improve the health and well being of my patients, both reconstructive and cosmetic.

Castle Connolly “Top Doctors” Recognition

I am honored to be selected, once again, as a Castle Connolly “Top Doctors” in Plastic Surgery for 2013. Castle Connolly Medical Ltd. is a health care research and information company recognized for their established survey and research process.  Their team of researchers follow a rigorous screening process of doctors’ educational and professional experience to make selections.  Doctors do not and cannot pay to be selected and profiled as “Top Doctors”. This is my fourth consecutive year for this selection and I am humbled to be recognized.