Breast Implant Lymphoma Advocate (BILA) Statement

Our deepest gratitude to the research pioneers and the faculty who presented at the 1st World Consensus Conference on BIA-ALCL in Rome, Italy on October 6, 2019.  Their approach to medicine is based in humanity, curiosity, passion and genius intellect.

A cascade of events that began 22 years ago with Keech & Creech (1997) has been marginalized by industry.  We will continue to confront the misleading and dangerous narrative that Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) is exceedingly rare, easily diagnosed at early stages, and easily curable.  This level of denial and dismissiveness is unacceptable and ignores the complexity and seriousness of our man-made cancer.

We challenge breast and plastic surgeons, radiologists, oncologists, and pathologists to PAUSE & RETHINK their previous knowledge and practice regarding breast implant safety.  In addition, we encourage them to educate their colleagues in other medical disciplines about breast implant lymphoma.

We are not opposed to implants.  All of us at one time chose implants as elective or reconstructive surgery. Women and their surgeons deserve options for safer implants. 

We support:

  • Evidence-based advocacy
  • Transparency for an ingredients list and manufacturing process
  • Mandatory standardized checklist for breast implants
  • Mandatory informed consent
  • Improved regulatory protection
  • Identify BIA-ALCL as uncommon & emerging cancer, “rare” is an obstacle to testing
  • Mandatory National Registries
  • Pathology update for capsule evaluation
  • Amend global obstacles preventing harmed patients from seeking damages

Let’s acknowledge that conflicts of interest are inherent with implants. Collaboration between patients, clinicians, manufacturers, and regulators is the only way forward.   Patients are the ultimate stakeholders.  We are invested in our health and provide real-world / time evidence; we deserve a seat at the table.

If you have textured implants, now what?

Request Imaging:  Breast MRI or Ultrasound establishes a baseline for you and your clinician to

monitor change, specifically scar capsule, fluid accumulation, lymph nodes and device integrity. 

  • The best plastic surgeons recommend regular follow up and imaging for on-going surveillance.  Implants are prosthetic devices and were never meant to be implanted and forgotten.  We ask plastic surgeons to expand your practice to include regular follow up
  • Mammograms are not recommended for BIA-ALCL investigation and are reserved for breast cancer malignancy not lymphoma.  

Self-Advocate & Stay Informed:  The prevalence of BIA-ALCL is potentially 10x higher than previously reported. 

  • Our goal is to educate NOT to evoke fear.  Patients deserve the unfiltered truth.  Everyone involved must be willing to continually learn, ask questions, and seek guidance from INFORMED sources.

Individual decisions must be based on one’s personal acceptable risk for textured implants.

  • The theory that asymptomatic women who chose prophylactic removal of textured implants will reduce cancer risk is unproven. If a patient has undiagnosed BIA-ALCL, cutting into active lymphoma can change the disease from indolent (slow growing) to rapid metastases.  There is no simple “one size fits-all” solution for women who currently have textured implants.

“Uncommon & Emerging Malignancy” has replaced RARE to describe BIA-ALCL

  • Uninformed clinicians appear to use “rare” as an obstacle for malignancy testing

Watch the video presentations from the 1st World Consensus Conference

  • Publishing medical literature is a critical but time intensive process.  For symptomatic women, time is of the essence.  Women must have access to lifesaving data as it emerges.  The information presented is a snapshot of today’s most accurate, leading edge data that continues to evolve at a rapid pace.

Click here, to view the YouTube video playlist by speaker.

Let’s clarify:

Why is this the 1st World Conference on BIA-ALCL? What makes it unique?

  • The Conference brings together leaders in research, science, implant registry, manufacturers and much more, creating a framework to move forward from multiple viewpoints.

There are NO SMOOTH only cases.  ALL diagnosed patients had a history of textured implants or implants of unknown type. 

  • Exception, patient diagnosed with a history of textured expander (reconstruction) left in place for extended time > 1 year.

Malignancy testing for symptomatic patients with high risk implants is a GLOBAL crisis.  Access to accurate evaluation by health care providers is critically needed. 

  • Educate yourself and assess your clinician for his/her knowledge of BIA-ALCL.  Be wary of plastic surgeons who minimize and patronize, rather than respond to your concerns with current data trending the complexity of our unique lymphoma.

A skilled plastic surgeon can achieve great results with smooth / round implants.

  • The argument for better aesthetic results from textured and teardrop shape implants is over, risk outweighs benefit. 

Patients deserve to be NOTIFIED, as recommended by FDA & American College of Surgeons.

  • We implore global regulatory agencies to mandate notification to all patients with textured implants about BIA-ALCL. We acknowledge and are grateful to hospitals/ surgeons who have led this campaign for patient awareness.

Accountability by Pharma Companies

  • We request any company that has a confirmed case of BIA-ALCL to voluntary recall textured products immediately.  Our diagnosed patient experience is irrelevant to brand.

Broken trust between patients and industry is reality.

  • While we cannot undo the past, we can change the future.  Lymphoma research was included in the post-market approval studies for USA and Canada in 2006.  The manufacturers were not compliant with study requirements.  Were the studies poorly designed?  Were they set up to fail?   What other revelations are yet to be uncovered? 

#PatientSafety, social media hashtag campaigns by industry are trending.

  • Be wary, marketing does not replace the accurate and current clinical data by well-informed clinicians.  Not all plastic surgeons are created equal; assess for humility to strengthen their knowledge on our lymphoma.  Respect that the plastic surgery landscape is changing rapidly, and they too are struggling to keep up to date. 

Clinicians, manufacturer(s) and media frequently over simplify.  This is dangerous and misleading to patient safety – please STOP.  BIA-ALCL is a complex blood cancer (hematology) and can be difficult to diagnose. 

From our BIA-ALCL patient experience, symptoms include:

  • A change in breast shape or implant shape
    • An increase in breast size
    • The development of or an increase in breast asymmetry
    • A change in the way the breast feels such as an increase in firmness
    • Pain in or around the breast
    • The development of a lump or lumps in or around the breast or under the armpit
    • Swollen lymph nodes
    • Intense itching or redness of the skin on or near the breast
    • Lesions on the skin on or near the breast
    • Fluid around the implant seen on imaging such as ultrasound and/or MRI
    • Masses or areas of increased thickness of the scar capsule around the breast implant as seen on imaging
    • Fever
    • Severe fatigue
    • Night-sweats

We again thank the pioneers from the 1st World Consensus Conference on BIA-ALCL.  Courage to   step outside industry pressure and their peers, inspires us.

We will be updating our patient driven website www.biaalcl.com as soon as possible.  We also thank www.justcallmeray.com, a non-profit organization, for its financial support to host this forum.  Contact us at info@biaalcl.com for more information.

Disclaimer: We are here to provide and share information on BIA-ALCL in real time. We are not physicians/surgeons.  This statement is not meant to offer individualized medical advice, but we recommend that you take the information you find here and share it with your doctors, so that you can get the individualized medical advice you need.

#biaalcl
#biaalcl.com 
#empoweringpatients
#patientsbeforeprofits
#bustthesilence