Breast Implant Illness
in Bucks County, PA, and Hunterdon County, NJ

If you are a resident of Doylestown, PA, Flemington, NJ, or surrounding states as far as New York, Delaware and Maryland, or Virgina Buinewicz Cosmetic Surgery & MedSpa provides treatment to those who have been affected by Breast Implant Illness. Dr. Brian Buinewicz is a leader in surgical removal of implants with capsulectomies and has helped many patients who have needed treatment for illnesses caused by breast implants.

What is Breast Implant Illness?

Breast Implant Illness is a constellation of symptoms potentially related to an abnormal immune response to breast implants. What is causing this illness is not known at this time, but is possibly an altered immune response to breast implants. What is causing the reaction and inflammation is unknown at this time (possibly a foreign body reaction, an inflammatory reaction to a contaminated implant, or a reaction to silicone or any of the chemicals used to make an implant). Many women notice the following symptoms in conjunction with Breast Implant Illness, but there are many other symptoms since Breast Implant Illness seems to affect almost every organ system in the body:

• Brian Fog
• Pain
• Fatigue
• Depression
• Anxiety
• Migraines
• Musculoskeletal issues
• Gastrointestinal issues
• Thyroid issues
• Vision changes
• Hair loss
• Rashes
• Acne

Symptoms such as tension, pressure, excess weight, stiffness, chronic chest wall and breast pain can be more mechanical issues not necessarily related to Breast Implant Illness.

Why Should You Trust Dr. Brian Buinewicz?

Dr. Brian Buinewicz is a triple board-certified plastic surgeon. He specializes in cosmetic and aesthetic plastic surgery and has helped many patients in his more than 23 years of experience. When it comes to treating Breast Implant Illness, Dr. Buinewicz has performed more than 800 explants and total capsulectomies, an average of about six procedures per week.

Dr. Buinewicz is a leader in this field and recently wrote an article for ScienceDirect titled Understanding Breast Implant Illness.

Key points:

• Review of breast implant illness symptoms and systemic complications.
• History of breast implants and the associated adverse events.
• The impact of certain breast implant-related chemicals like silicone on the body.
• Explantation of the breast implant and capsule reduces systemic symptoms in all populations.
• Saline and silicone, smooth, and textured all come with risks of cancer.
• Identifying the patients’ need for explant based on the clinical symptoms and imaging studies.

Click here to read the article.

Dr. Buinewicz is praised among his patients. In fact, one of his former patients, Tara Hopko, wrote a book detailing the Breast Implant Illness treatment procedure and how Dr. Buinewicz helped her in her time of need. The book, “Let Me Get This Off My Chest,” explains the seriousness behind Breast Implant Illness and how Dr. Buinewicz is able to effectively treat and help patients.

Many women in the greater Philadelphia and New Jersey areas have come to Dr. Buinewicz seeking help for complications caused by silicone and saline implants. We see and treat patients from many states - it is an honor and complement that patients will travel to Dr. Buinewicz for care.

What Treatment Options are Offered by Dr. Buinewicz?

Dr. Buinewicz offers removal of the implants or implant material, cultures of the capsule and a complete total capsulectomy. A total capsulectomy means complete removal of the capsule.  An “En Bloc” capsulectomy is a total capsulectomy without making any tears or holes in the capsule.  This usually requires sacrificing normal tissue (en bloc is a term used for cancer operations).  Many times an en bloc capsulectomy is technically not able to be performed due to thinness of the capsule, adherence of the capsule to important structures or other technical issues. However a complete, total capsulectomy is always the goal and can be performed with minimal complications.  In our initial retrospective study, we saw no difference in improvement in symptoms between en bloc capsulectomies versus total capsulectomies.  This explant and total capsulectomy are always performed by the doctor himself. He may provide a teaching opportunity to a student or resident, but Dr. Buinewicz will be the only professional performing the actual operation.

When performing the explant procedure and capsulectomy, Dr. Buinewicz is very thorough. He carefully examines the area where the implants were and cultures the inside of the capsule. The surgical site is thoroughly irrigated with saline solution and then a drain is placed.

While treating Breast Implant Illness, Dr. Buinewicz also checks for irregular lumps and masses in the chest and breasts. He recommends annual mammograms following the explant.

What is the Recovery Time for this Treatment?

There is no clear recovery timeline for this treatment. Most patients have their drains removed and are showering within 4-5 days. Average time until being able to drive is about one week. Because of the pain blocks Dr. Buinewicz uses, recovery is faster and patients use little to no narcotics. Many patients will heal and start feel better within 4-6 weeks. This timeline may extend or lessen depending on the extent of the procedure - everyone heals differently.

What Follow-Up Care Will Be Needed?

It is recommended that patients routinely follow-up with Dr. Buinewicz until the healing process is complete. He will provide personalized and meticulous care for each and every patient. Patients will need to return to one of the offices to have drains removed and incisions checked, but after that is complete, follow-up care will be provided as necessary. Once you are a patient of the practice, you are a patient until the healing process and your recovery is complete.

Frequently Asked Questions

What is Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)?

BIA-ALCL is a rare spectrum of disease that can range from an indolent accumulation of fluid around the breast (seroma) to a potentially metastatic lymphoma especially when there are delays in diagnosis. BIA-ALCL is not a cancer of the breast tissue itself. When diagnosed early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

BIA-ALCL is currently classified as a lymphoma. Many experts believe that it behaves clinically as a lymphoproliferative disorder (LPD) that encompasses the spectrum of disease from benign CD30+ seromas, to CD30+ malignant seromas, to invasive capsular disease, and finally metastatic disease. Current ASERF research is underway to further understand the proper classification of this disorder. Similar to LPDs, BIA-ALCL is a highly treatable disease with high cure rates.

Have there been any deaths due to BIA-ALCL?

As of January 4, 2021 FDA reports 933 confirmed cases world wide of ALCL with 36 confirmed deaths globally, (13 in the United States), attributed to BIA- ALCL since the disease was first reported nearly 20 years ago.

What are the symptoms of BIA-ALCL?

The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.

What is the risk of developing BIA-ALCL?

The FDA reports that it is 1:2,207 to 1:86,029 based on the type of implant in their latest statement. These risk assessments are changing on an ongoing basis, but this is the most accurate information currently available.

Based on current data, the risk can be further defined by the degree/type of texture of the implants as follows:

• Grade 1 (Smooth only) – In global databases, there has not been a confirmed case of BIA-ALCL in a patient who had smooth implants only. In the Feb 2019 FDA statement, it was reported that “there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis.” At the time of this publication, it is known that a single case of smooth only BIA-ALCL was originally reported to the FDA; however, it was later determined that this was not accurate and that the patient had received textured implants followed by smooth implants, and the report to the FDA was amended.
• Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
• Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
• Grade 4 (e.g. Polyurethane) – 1:2,800*

*Based on data from an Australian study – however, this was 100% Silimed polyurethane implants that had a manufacturing defect and have since been taken off the market. Loch-Wilkinson, A., et al. (2017). “Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk.” Plast Reconstr Surg 140(4): 645-654

On July 24, 2019, in response to a request by the FDA, Allergan reported a voluntary recall of all BIOCELL® textured implants and expanders, worldwide. The recall includes the Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone- Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL® textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US,” the FDA said in a statement.

What does FDA mean by a “recall”? Should current BIOCELL® patients be contacted and have their implants removed?

This is a recall of unused Biocell implants (Biocell inventory and sold Biocell products) but not Biocell implants that have been used in patients who are asymptomatic. The FDA does not recommend or suggest that asymptomatic patients be explanted; rather that the company refrain from selling BIOCELL® implants moving forward. Patients with these implants should see their plastic surgeon for evaluation, examination and any further studies or treatments as indicated based on their evaluation.

If a breast implant patient sees a plastic surgeon when she develops the first symptom, will she be cured?

That answer is not known and is a very important piece of information for patients and plastic surgeons. Most of the time patients see their plastic surgeon right away when they develop enlargement of the breast. In these cases, the disease is almost always cured with a straightforward operation. Some women with advanced disease did not act on earlier symptoms or saw a doctor who did not properly diagnose/treat them. There are a few patients who presented with advanced disease who said that they never had earlier symptoms.

Can you explain the differences in implant texture and what role that factor plays in the research?

BIA-ALCL appears to currently develop exclusively in women with textured implants. To date, there has not been a case of BIA-ALCL in a patient with only smooth implants. There is a small number of patients with smooth implants who are reported as having BIA-ALCL, but these patients have a history of having textured implants or another type of implant previously.  There are several theories which attempt to explain the higher rate for textured implant patients: one theory is that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients, and can result in chronic inflammation, ultimately leading to a proliferation of lymphocytes. Another theory is that textured implants create greater inflammation because of chronic mechanical irritation, and another postulates that microscopic shedding of silicone from the textured wall induces inflammation.

Is it a problem with Saline or Silicone implants?

Of the 733 unique cases of BIA-ALCL (FDA 1-2020) implants are both silicone and saline. It appears to purely be related to the surface of the implant and not to what the implant contains.

How does this impact those with breast implants?

American Society of Aesthetic Plastic Surgeons and Aesthetic Surgery Education and Research Foundation emphasize that the most important issue for all women, with and without breast implants, is to screen for breast cancer with self-exam, a regular physical exam, and mammography/ultrasound/MRI as recommended by their physician. Since breast cancer occurs in approximately 1 in 8 women, breast cancer is a far greater risk than BIA-ALCL. All women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.

What about those considering breast implants?

Patients considering breast implants should discuss the issue with their plastic surgeon. Since our knowledge of this condition is continuing to evolve, thanks in large part to ASERF- sponsored research, patients should check surgery.org and the FDA website for any updates.

What if a doctor is recommending textured implants to a patient?

The choice of implant type is ultimately a decision between an educated patient and her board-certified plastic surgeon.

How is BIA-ALCL diagnosed?

If a woman develops swelling in an augmented breast, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested for:

1. Cytology
2. CD30

CD30 immunohistochemistry is not diagnostic for BIA-ALCL; however, it is a marker for activated T-Cells. If a patient’s seroma is CD30 positive, and the cytology is negative, this likely represents a precursor to BIA-ALCL and should be treated with total capsulectomy. If the seroma test is CD30 negative with negative cytology, then it should be treated as a benign seroma using the individual surgeon’s protocol.

The majority of seromas seen clinically are benign seromas and not BIA-ALCL.

Management of all seromas should be by a board-certified plastic surgeon. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases, PET or MRI/CT scans may be used to help stage the disease.

If a patient wants to have their textured implants removed and replaced, the options are:

• Exchange to smooth implants
• Exchange to smooth implants with a capsulectomy

How is BIA-ALCL treated and what is the prognosis?

Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a  common procedure performed by plastic surgeons, identical to what is done when an implant has ruptured or capsular contracture has developed. Smooth implants can be inserted or the patient can choose not to have implants replaced. In all early-stage cases, the disease has been fully cured by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or grown into the adjacent tissues, chemotherapy and radiation may be necessary.

Are some patients at greater risk than others?

The rates of BIA-ALCL seem to have different rates throughout the world. This may be due to different reporting and registries, but there is likely to be a genetic predisposition that is not yet fully understood. For instance, as of this time, there are very few cases in Asian patients. As mentioned, the risk is only with textured implants and not smooth implants; the rate is no different between silicone and saline; it occurs in both cosmetic and reconstructive patients. There is no test to determine whether one textured implant patient is at any more risk of developing this disorder than any other patients.

Should patients have their implants removed because of BIA-ALCL?

For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA- ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to proceed.

Breast implant patients should have ongoing follow up. Current FDA recommendations and ASAPS recommendations are that patients with textured implants with no symptoms should not do anything and implant removal is not recommended. If the patient has silicone filled implants, then the FDA recommends an initial ultrasound about 5-6 years after implantation and follow up ultrasounds every 2-3 years based on yearly physical exams. MRI is indicated when the ultrasound is equivocal or an MRI is recommended.

Should women with breast implants be screened for BIA-ALCL?

There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.

What causes BIA-ALCL?

ASAPS, ASERF, the FDA, and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study.

The best theory today is that a combination of factors is required for the development of BIA-ALCL:

• Textured implants (surface area to sequester bacteria)
• Chronic inflammation
• Genetic predisposition
• Time

Genetic factors may play a role. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether there are any genetic propensities for this disease.

Does ASAPS recommend against the use of textured implants?

The best practice is for the physician to discuss with each patient the known risks and potential complications associated with any procedure.

What is the recommended clinical response to a patient presenting with symptoms that could be attributable to ALCL?

Detailed information can be found on the ASAPS website at: http://www.surgery.org/professionals

Where can I find more information on BIA-ALCL?

Additional information and resources on BIA-ALCL are available online at https://www.surgery.org/media/resources, www.fda.gov or www.plasticsurgery.org

Is there any assistance available to the patient?

The Mollenkopf Aesthetic Breast Reconstruction Fund and the BIA-ALCL Patient Assistance Fund can offer financial assistance to patients. Additionally, Sientra offers to cover lab testing for any seromas associated with their implants.

The Mollenkopf Aesthetic Breast Reconstruction Fund: http://www.aserf.org/attachments/223_mollenkopf-grant-request-form.pdf

The Aesthetic Surgery Education and Research Foundation (ASERF) is pleased to announce available funding for breast reconstruction patients. The Mollenkopf Aesthetic Breast Reconstruction Fund provides grants to ASERF/ASAPS member surgeons, to financially assist patients in completing their aesthetic breast reconstruction journeys. These funds are intended to help underinsured or uninsured patients nationwide cover the associated costs with breast reconstruction. The goal of this fund is to provide women with limited financial means the opportunity to achieve the best possible aesthetic breast reconstruction result. In particular, the grant is focused on women who need a final surgical procedure to complete their aesthetic reconstruction. The goal is for ASERF/ASAPS members to help women feel good about themselves after their reconstruction and aid them in returning “back to me.”

The BIA-ALCL Patient Assistance Fund: http://www.aserf.org/images/documents/bia- alcl-patient-fund-grant-request-form.pdf

The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS), in conjunction with the Aesthetic Surgery Education and Research Foundation (ASERF) and the Plastic Surgery Foundation (PSF), are pleased to announce funding for patients diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). These funds are intended to help underinsured or uninsured patients who are seeking surgical treatment of BIA-ALCL, total capsulectomy and explanation, and excision of the associated mass with biopsy of the suspicious node(s) and implant-based reconstruction, if indicated. The goal of this Fund is for ASAPS, ASPS, ASERF, and PSF members to help patients obtain treatment when insurance limitations would have otherwise restricted their ability to do so. The Fund is made possible by generous contributions from Allergan, Mentor Worldwide, LLC and Sientra, Inc.

Sientra: http://sientra.com/Content/pdfs/LGL-0006%20R2- Sientra%20Warranty%20Terms%20and%20Conditions.pdf

The Sientra Platinum20TM Product Replacement and Limited Warranty Program for Sientra OpusTM Silicone Gel Breast Implants (Smooth and Textured Surface) offers assistance with patients presenting with late-forming seromas.

What research is being conducted?

ASERF is currently funding two BIA-ALCL studies on the Pathogenesis of BIA-ALCL and Genomic Profiling to Understand the Pathogenesis of BIA-ALCL.

ASERF is sponsoring leading, cutting edge research on BIA-ALCL to better define the disease and improve diagnosis and outcome. More information can be found on the ASERF website: www.aserf.org

Dr. Buinewicz is actively enrolling patients with suspected Breast Implant Illness having total capsulectomies and implant removal in an ongoing prospective trial as a follow up of our initial retrospective study and to address the limitations of a retrospective study. To date we have 106 patients enrolled

• ASAPS Manuscript
• ASAPS Abstract

 

 

 

 

Outcomes of Implant Removal and Capsulectomy for Breast Implant Illness in 248 Patients

Abstract

Background:
Breast implant illness (BII) is a term popularized by social media to describe systemic symptoms that patients ascribe to their breast implants. Though the concept of implants as an underlying cause for a systemic illness remains controversial, few studies have delineated the implant characteristics, capsular histology, and outcomes of patients who undergo explantation for BII.

Methods:
We retrospectively reviewed the demographics, presenting symptoms, outcomes, capsular histology, and culture results of all women who presented to the senior author with symptoms attributed to BII and underwent breast implant removal with capsulectomy from August 2016 to February 2020. Chi-square and logistic regression analyses were performed to evaluate association between implant type, composition, and findings of inflammation on capsule pathology.

Results:
Among 248 patients, 111 (23%) capsules demonstrated inflammatory changes on permanent pathology. Capsular inflammation was independently associated with silicone versus saline (right odds ratio [OR] = 2.18 [1.16–4.11], P = 0.016, left OR = 2.35 [1.08–5.12], P = 0.03) and textured versus smooth implants (right OR = 2.18 [1.16–4.11], P = 0.016, left OR = 2.25 [1.17–4.31], P = 0.01). Silicone material was present in the capsules of 12 patients (4.8%). Fourteen patients had positive cultures. There was one pneumothorax (0.4%), three hematomas requiring evacuation (1%), and two DVTs (0.8%). Of 228 patients, 206 (90.4%) reported high satisfaction with the outcome of the procedure.

Conclusions:
In a large cohort of BII patients, we found that capsular inflammation is significantly associated with silicone and textured implants. Implant removal with capsulectomy can be safely performed in patients with BII with a low complication rate and high patient satisfaction.

Read More

I rarely put breast implants in patients any more - I am usually able to talk them out of them when we go over risks, but I do have breast reconstruction patients that I still treat and follow. If someone wants an implant and makes a well informed decision to do so, then they should be able to choose to proceed (just like making the decision to take them out). My job as their treating physician is to make sure they make a well informed decision to proceed with surgery and understand all risks and to follow these patients long term while their implants are in. If they have any issues down the road, I want them to feel comfortable that they can see me and I will remove them and provide care (not like the usual stories you hear).

The en bloc issue is very controversial. En Bloc is a total capsulectomy where you remove the capsule and implant in one piece without tearing it. A total capsulectomy is removing the capsule completely, but there are tears. En Bloc surgical resections are what you do for cancers - take normal tissue to make sure you grossly remove everything. To accomplish this, you must sacrifice normal tissue, and possibly muscle and bone. This would mean removing some or all of your breast in addition to possibly some of your chest wall. This potentially could significantly deform a patient and more importantly could permanently affect their health and function as well as lead to other comp[lications. There are NO published studies yet showing that there is an improvement in outcomes with BII if you do an en bloc capsulectomy. My published data as well as preliminary data from the ASERF breast implant illness research project confirm this - I hope other surgeons will publish their data as I continue to do. This is what we will be addressing also with our ongoing prospective study. I have performed close to 1000 capsulectomies and most are total capsulectomies ( capsule completely removed with some tears) not en bloc. My patients continue to see around 85% significant improvement in symptoms and around 70% completely recovered with low complication rates and relatively quick return to function..

I worry more that someone out there is pushing for guarantees with surgical procedures - it is unethical as a physician to guarantee any outcomes or part of any procedure because there are inherent risks that we as physicians cannot control. That's why you will read and sign and detailed informed consent that we will review at your preoperative appointment. I took the Hippocratic Oath when I graduated medical school and will always adhere to the dictum of " first do no harm". If someone (doctor or not) guarantees anything, get it in writing - or better yet, run the other way.

If you remember years ago when women had breast cancer, radical or modified radical mastectomy were performed - now the majority of patients can save their breast with lumpectomies and have the same long term results. We learned from ongoing research and follow up of patients that being overly aggressive is not always necessary in this example. That being said, total vs en bloc vs partial capsulectomy is one of the "hot topics" in breast implant illness syndrome and absolutely needs more published research. Remember, removing the implants and capsules is the first step to getting better, not the only step. Silicone is a bioactive molecule and your body's immune system will have the ability to start to heal once the toxin is removed from you. Many patients do need extra help with this, hence the detoxification protocols for breast implant illness syndrome. I hope this helps clear things up.

Contact us to schedule a personalized consultation with Dr. Buinewicz. He will provide the best treatment option for you and your Breast Implant Illness. Treatment options are available in Bucks County, PA, and Hunterdon County, NJ.