Breast Implants - Risk of Anaplastic Large Cell Lymphoma (BIA-ALCL)

Starting date:

November 24, 2017

Posting date:

November 24, 2017

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

New safety information

Audience:

Healthcare Professionals

Identification number:

RA-65188

• 
  Issue
• 
  Who is affected
• 
  Report health or safety concerns

Audiences

Healthcare professionals including family physicians, obstetricians and gynaecologists, oncologists, general pathologists and hematopathologists, hematologists, radiologists, general and plastic surgeons.

Key messages

• Rare cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been reported in Canada and internationally.
• Available data, from literature and international regulators, suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces compared to those with smooth surfaces.
• Healthcare professionals are encouraged to learn more about the signs, symptoms and testing steps to recognize and diagnose BIA-ALCL.
• Health Canada is working with manufacturers to update this safety information on the product labelling for breast implants.

Issue

A safety review on the risk of BIA-ALCL was initiated by Health Canada to determine a Canadian-specific rate of BIA-ALCL cases relative to the number of implants sold over the past 10 years. The safety review determined that the rate of BIA-ALCL reported to Health Canada is low and cases are mainly associated with breast implants with textured surfaces.

Products affected

All breast implants marketed in Canada are potentially impacted, including products by Allergan Inc., Mentor, and Ideal Implant Incorporated (c/o Clarion Medical Technologies).

Background information

Breast implants are medical devices. Breast implants can be filled with silicone gel or saline. They have shells made from silicone which can have a smooth or textured surface. They are intended for increasing breast size, replacing a previous implant, correcting breast asymmetry, or reconstructing breasts following surgery, such as a mastectomy.

As defined by the World Health Organization (WHO), BIA-ALCL is a rare type of non-Hodgkin lymphoma that can develop next to the implant. It usually presents as an accumulation of seroma fluid between the implant itself and the surrounding fibrous capsule. 

Five Canadian cases of confirmed WHO-defined BIA-ALCL¹ were reported to Health Canada by the manufacturers in the last 10 years. Although deaths associated with BIA-ALCL have been reported globally, none of Canadian cases reported a fatal outcome.

The exact global incidence rate is difficult to determine due to limitations in worldwide reporting and lack of global sales data. Based on the cases reported to manufacturers, the rate of WHO-defined BIA-ALCL cases per implant sold over the past 10 years in Canada is 0.0013% or 1 case per 77,190 implants sold. The surface type of the implant was reported in 4 cases (textured implants) and was unknown in 1 case. The rate per textured implant was estimated at 0.0041% or 1 case per 24,177 textured implants sold. However, Health Canada acknowledges that some cases may not have been reported to the manufacturers or to Health Canada during this time period.

Cases of BIA-ALCL have been reported with both saline and silicone gel implants. Available data in Canada and internationally suggest that the BIA-ALCL is more frequently reported with implants with textured surface rather than smooth surface. Of note, approximately 25% of breast implants sold over the past 10 years in Canada are textured implants. The etiology of BIA-ALCL remains unclear, and areas of ongoing research include chronic inflammation, bacterial contamination (role of biofilm), severe capsular contracture and trauma to the breast.

Who is affected

Information for consumers

Breast implants are medical devices. Breast implants can be filled with silicone gel or saline. Breast implants licensed for sale in Canada have shells made from silicone and are available with either a smooth or textured surface. They are intended for increasing breast size, replacing a previous implant, correcting breast unevenness or appearance, or reconstructing breasts following surgery, such as a mastectomy.

Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that originates from lymphatic cells, which are part of your immune system (the system which fights infections). It is not a cancer of the breast tissue (i.e., breast cancer). There have been rare case reports of women with breast implants developing breast implant-associated ALCL (BIA-ALCL). It has been found in the scar tissue surrounding breast implants in some women. At this time, data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Breast implants are not lifetime devices. Conduct regular breast self-exams and see your surgeon for periodic follow-up. If you do experience unusual changes to your breast, including sudden swelling or a lump, you should consult your doctor, who can send you for subsequent testing if necessary.

Removal of breast implants is not recommended if you do not have any signs or symptoms suggestive of BIA-ALCL.


If testing confirms BIA-ALCL, most cases (which are isolated to the scar tissue formed around the breast implant) are treated successfully by removal of the breast implant and scar tissue. However, if the BIA-ALCL has infiltrated the scar tissue, lymph nodes, or a lump is found, affected women will need treatment by a multidisciplinary team (including but not limited to oncologist, surgical oncologist, plastic surgeon, hematopathologist). Treatment options for the infiltrative type of BIA-ALCL include chemotherapy and/or radiation. In some cases where BIA-ALCL has spread beyond the scar tissue, rare cases of death have been reported.

Information for healthcare professionals

BIA-ALCL has been known to occur mainly in textured breast implants. The most common presentation of BIA-ALCL is a delayed (over one year, on average of 8-10 years, following implantation) periprosthetic fluid collection often referred to as late seroma. The late seroma can manifest as a swollen breast, breast asymmetry or pain in the breast. Patients can also present with capsular contracture, skin changes, and regional lymphadenopathy. Physical signs of BIA-ALCL can also include effusion, enlargement, mass and ulceration and can present similarly to a common infection (pain, redness, soreness, and swelling).

In order to diagnose BIA-ALCL [an anaplastic lymphoma kinase (ALK) negative, cell-surface protein CD30 positive T-cell lymphoma], a specific cytology workup is required, both of aspirated seroma fluid and representative samples of the capsule. The cytology work-up includes immunohistochemistry (IHC) and/or flow cytometry for T-cell markers and CD30. The diagnosis of BIA-ALCL may be missed if these specific tests are not done.

In most cases, in which the disease is contained within the capsule with no mass, BIA-ALCL can be adequately treated by surgical removal of the implant and complete capsulectomy. However, in some cases, the BIA-ALCL may infiltrate the capsule and there is a risk of lymph node involvement, chemotherapy and/or radiotherapy may be required.  In some of the cases where infiltrative BIA-ALCL has spread beyond the scar tissue, rare cases of death have been reported.

   

Healthcare professionals are advised to consult clinical practice guidelines to guide the diagnosis and treatment of BIA-ALCL.^2,3,4

Removal of breast implant is not recommended if the patient does not have any signs or symptoms suggestive of BIA-ALCL.

Action taken by Health Canada

Health Canada is working with manufacturers to include this safety information on the product labelling for breast implants. Health Canada is also communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of BIA-ALCL or other serious or unexpected side effects in patients with breast implants should be reported to the manufacturer or Health Canada. The reports should include specific details, such as: symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, course of therapy and clinical outcomes.

Allergan Inc.

By Phone: 1-800-624-4261

By email:  AUS-BreastInternationalComplaints@Allergan.com

Mentor

You can report any suspected adverse reactions associated with the use of Mentor products to PQS@medca.jnj.com or directly to Health Canada as per below.

Ideal Implant Incorporated, c/o Clarion Medical Technologies

By Phone: 1-800-668-5236

By email:  regulatory@clarionmedical.com

To correct your mailing address or fax number, contact the manufacturer.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca   

Telephone: 613-954-6522  

Fax: 613-952-7738

Original signed by

________________________

Alain Lamontagne, Ph.D.

Associate Vice-President and Head of LACAN (Latin America and Canada)

Chief Medical Office

Allergan Inc.

______________________________

William J Kane MD, FACS

Franchise Medical Director, Medical Affairs

Cardiovascular & Specialty Solutions (CSS) Group

Part of the Johnson & Johnson Family of Companies

Diplomate,American Board of Plastic Surgery

Diplomate, American Board of Otolaryngology/H&N Surgery

_______________________________

Robert S. Hamas, M.D.

CEO and President

Ideal Implant Incorporated

References

1. Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood 2016;127(20):2375-90.
2. http://plasticsurgery.ca/wp-content-csps/uploads/2016/05/NCCN-Guidelines-2.pdf
3. http://plasticsurgery.ca/medical-professionals/information-plastic-surgeons/alcl/
4. https://www.plasticsurgery.org/patient-safety/information-on-bia-alcl