Allergan Breast Implants – Focus Blocks

Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (Augmentation) or to rebuild breast tissue after Mastectomy or other damage to the breast (Reconstruction).

What is the problem with Allergan breast implants? Reason for recall?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The Food & Drug Administration (FDA) research suggests that the breast implants risk of cancer may depend on what kind of implants you have. Textured implants pose the greatest risk, while a much smaller number of BIA-ALCL cases involve smooth implants.

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

BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma, a T-cell lymphoma (Cancer of the immune system). It can take up to ten years for ALCL to develop, which helps explain why it took several years for the FDA to go from a potential link to an established one.

What are the symptoms of BIA-ALCL?

Symptoms such as swelling in the neck, armpit, groin, fatigue, fever, loss of appetite, pain, night sweats, weight loss, swollen lymph nodes.

Who makes textured breast implants in the United States?

A number of companies’ manufacturer prosthetic breast implants sold on the U.S. market. Among those,

Manufacturer: Allergan.

Allergan (formerly called Inamed and McGhan), which makes both smooth and textured versions of its Natrelle implants

On July 24th, 2019 Allergan plc (NYSE: AGN) announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of BIA-ALCL provided by the U.S. FDA.

The FDA first noted a potential link between breast implants and ALCL in 2011, but at that point it had not received any reported fatalities. It also lacked a strong enough body of evidence to establish a solid connection.

The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.

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 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.

Recalled products:

Natrelle Saline breast implant styles 168, 363, 468
Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
Natrelle 510 Dual-Gel styles LX, MX, FX
Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
Natrelle 150 Full Height and Short Height double lumen implants
Natrelle 133 tissue expanders with and without suture tabs:  styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T

 

Indications:

 

  • Breast augmentation for women at least 22 years old.
  • Breast reconstruction
  • Revision of previous breast augmentation or reconstruction to correct or improve the result of the previous surgery

Contraindications:

  • Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
  • Women with active infection anywhere in their body.
  • Women who are currently pregnant or nursing

Complications:

  • Anaplastic large cell lymphoma, a type of non-Hodgkin’s lymphoma (cancer of the immune system)
  • Fluid buildup
  • Interference with the accuracy of mammography
  • Hardening of or mass around the implants
  • Hematoma/ Seroma
  • Capsular contracture
  • Changes in nipple and breast sensation
  • Failure or inadequate Lactation
  • Calcium deposits in the tissue around the implant
  • Necrosis
  • Scarring
  • Infection at the incision site/ Infection, including Toxic Shock Syndrome
  • Delayed wound healing
  • Breast tissue atrophy/chest wall deformity
  • Asymmetry
  • Breakage/ Extrusion/ Microleakage (sweating or bleeding of silicone outside the shell)/ Rupture or deflation of the implant
  • Additional surgeries, with or without removal of the device

A second NCI study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.38. The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulva cancer. Swedish and Danish studies also found a significantly increased risk of lung cancer among augmentation patients, but those studies did not control for smoking

Case Review Focus Areas:

  1. Was Allergan breast implant used – Identify manufacturer and product
  2. Reason for Allergan breast implant?
  3. Was benefits and risks of Allergan breast implant discussed with patient?
  4. Did the patient suffer from any lymphoma in the past?
  5. Did the patient develop breast implant-associated anaplastic large cell lymphoma after the Allergan breast implant use?
  6. Follow-up visits for symptoms of ALCL, treatment/management
  7. Outcome/prognosis
  8. Any prior breast surgical history?

Identify and report cases with the following scenarios:

  1. No Injuries: Allergan breast implant was used in patient but did not develop any injury (No injury – Case screening)
  2. No Allergan breast implant use: Patient underwent breast surgery, but Allergan breast implant was not used

Identify and report on missing medical records:

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

What Records/Medical Bills are NeededHospital/

Medical Provider

Date/Time PeriodWhy we need the Records/BillsIs Record Missing Confirmatory or Probable?Hint/Clue that records are missing