Update – July 24, 2019: The Food and Drug Administration issued a recall notice for Allergan Biocell breast implants to be withdrawn and discontinued from use in the US market.
The breast augmentation manufacturer, Allergan, notified the agency it would be withdrawing all of its Biocell textured implants and tissue expanders from the worldwide cosmetic surgery market due to the possibility of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This also includes reconstructive implantation after a mastectomy.
The company said in a press release, “Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan.”
A comprehensive list of the recalled implants and tissue expanders can be found at the end of this update.
The textured implants and tissue expanders have been associated with global cases of BIA-ALCL and related deaths. The FDA analyzed hundreds of BIA-ALCL reports and found a total of 573 worldwide cases that included 33 deaths. Of those cases, 481 included those with Allergan breast implants.
Furthermore, 12 of 13 deaths that happened with those diagnosed with BIA-ALCL, specifically involved the patient having Allergan implants. The remaining 20 deaths have an unknown manufacturer and/or texture identification.
The FDA said in the statement: “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 textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
Recalled Breast Implants:
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant). Approved under P990074.
- Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
- Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
- Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
- Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:
- Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
- Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
- Style 120 – BIOCELL Textured Round High Projection Gel Filled Breast Implants
- Style TRL – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRLP – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRM – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRF – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRX – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. The following are the textured styles:
- Style 410FM
- Style 410FF
- Style 410MM
- Style 410 MF
- Style 410 FL
- Style 410 ML
- Style 410 LL
- Style 410 LM
- Style 410 LF
- Style 410 FX
- Style 410 MX
- Style 410 LX
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
Update – May 30, 2019: Health Canada suspended breast implant manufacturer, Allergan, from selling its macro-textured Biocell breast implants due to a high incidence of cancer in patients with them.
This specific type of implant was reported in 85 percent of 26 cases of BIA-ALCL and it’s the only macro-textured implant available in the region. The ban was put in place primarily because of a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Health Canada believes the risk of BIA-ALCL cancer is 1 in 3,565 compared to 1 in 16,703 for Mentor Siltex micro-textured breast implants. These numbers were based off confirmed case data and device sales data provided by the manufacturers.
Health Canada initially threatened Allergan it would suspend its implant license unless the company could provide evidence the benefits of them outweigh the risks within two weeks. Ultimately Health Canada found the company’s response was “insufficient to support the ongoing licensing of the devices.”
Allergan agreed to voluntarily recall any unused Biocell macro-textured implants from the market but plans to appeal the decision.
Breast implants linked to cancer
According to the American Society of Plastic Surgeons, over 400,000 people in the United States receive breast implants each year. Nearly 300,000 of these procedures are categorized as cosmetic, while the remaining 100,000 are known as reconstructive surgeries.
In a cosmetic procedure, the patient has decided to augment their own figure with the help of implants. According to the ASPS, the average cost of a cosmetic breast implant surgery in the United States is $3,824. For a reconstructive surgery, implants are used to recreate the typical shape and size of breasts after a mastectomy (breast removal surgery).
Recently, the synthetic implants used in both cosmetic and reconstructive procedures have been linked to a rare T-cell lymphoma known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Breast implant history
Since the late 1800s, breast implants have been used to surgically enhance the size, shape and feel of a persons breasts. They are generally characterized as prosthetic implants defined by their filler material of either saline solution, silicone gel, or a composite filler (fat grafting).
Composite filled breast implants that use miscellaneous fillers like soy oil or polypropylene string, are banned in United States and Europe due to associated health risks and complications.
Breast implants are used in reconstructive plastic surgery to restore a natural breast shape after a mastectomy. Generally, all type of breast implants utilize an elastomer silicone shell, which is thought to be the cause of BIA-ALCL.
What is BIA-ALCL?
BIA-ALCL is a T-cell lymphoma found in the breasts of those with implants. It is important to note that BIA-ALCL is not breast cancer. It is a type of cancer, known as non-Hodgkin’s lymphoma that affects the immune system. This cancer can attack different parts of the body, including the skin and lymph nodes. It has been suggested that BIA-ALCL occurs more frequently following textured, rather than smooth-feeling breast implants.
What are the symptoms BIA-ALCL?
Symptoms of BIA-ALCL vary widely and are initially preceded by persistent swelling or pain in the vicinity of the breast implant. This pain persists well after the surgical wound has healed. BIA-ALCL symptoms may often mirror the symptoms of breast cancer. If you experience any of these symptoms, contact your health care provider immediately:
- Any unexplained change in the size or shape of the breast
- Dimpling anywhere on the breast
- Unexplained swelling of the breast
- Unexplained shrinkage of the breast
- Recent asymmetry of the breasts
- Nipple that is turned slightly inward or inverted
- Change in the skin of the breast
- Nipple tenderness or a lump or thickening in or near the breast or underarm area
- A change in the skin texture or pore size of the breast
- A lump or abnormal swelling in the breast
Although symptoms mirror those of breast cancer, BIA-ALCL effects the area surrounding the implant itself. This effusion fluid will almost always cause the breast to swell and become tender.
The devastation of those affected by implant-induced BIA-ALCL
Due to the fact that some patients receive breast implants as part of a reconstructive surgery from a mastectomy, a secondary diagnosis is incredibly devastating. In 2017, the New York Times profiled a 43-year-old woman who was diagnosed with BIA-ALCL after nearly losing her life to breast cancer just six years prior.
“My whole world came crumbling down again,” said Raylene Hollrah of Montana. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.”
The story detailed an FDA update outlining nine deaths linked to BIA-ALCL. At the time, it was speculated the number of adverse reports would grow since that doctors were only barely beginning to be warned about the correlation between breast implants and BIA-ALCL.
Only 30 percent of plastic surgeons were talking about cancer with their patients undergoing surgery, according to Dr. Mark W. Clemens II, an expert on BIA-ALCL and plastic surgeon at the University of Texas MD Anderson Cancer Center in Houston.
From 2000 to 2016, breast augmentation rose 37 percent, while reconstruction after a mastectomy rose 39 percent. Both Allergan and Mentor are still the biggest manufacturers of breast implants.
Health insurance complicates BIA-ALCL
Many experts agree the best action to take after a BIA-ALCL diagnosis is to remove the implant and scar tissue surrounding it. The disease is likely to recur and worsen should the implant stay in place. Not only is this diagnosis and procedure devastating to the patient, it’s also a financial and emotional burden. Even if covered by insurance, the time of recovery, missed work, or quality of life may be severely impacted.
Kimra Rogers of Idaho was one such patient that has encountered a bureaucratic nightmare from her lymphoma diagnosis. According to Rogers, her doctor didn’t have the “first line of defense” to combat the correlation between her implants and lymphoma. She was prescribed chemotherapy and radiation, but no implant removal.
Her insurance, Blue Cross Blue Shield, was willing to cover those treatments but refused to pay for the implant removal as the company indicated her appeal rights had been “exhausted.”
The insurance company issued a statement to The New York Times that said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”
How the FDA has addressed BIA-ALCL
The Food and Drug Administration has issued a series of warnings for breast implants and even demanded label changes which outline the dangers of BIA-ALCL.
In a Q&A letter to the public, the agency states, “The World Health Organization that BIA-ALCL is a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”
The FDA went on to state that patients with late onset, persistent peri-implant seroma were at higher risk for BIA-ALCL. There have been accusations that the FDA hasn’t done enough to warn patients of this potentially deadly complication.
FDA update in 2019
In May 2019, the FDA announced a rollout of steps the agency is taking to help the public better understand potential risks of breast implants. In March, the FDA held a two-day public advisory meeting with breast implant patients afflicted with BIA-ALCL, medical and health professionals, stakeholders and more, to discuss the urgency of understanding this rare form of lymphoma.
“To that end, the information we’ve garnered, from this meeting and other ongoing efforts, makes clear there is an opportunity to do more to protect women considering breast implants.”
The agency announced all breast implants will no longer be categorized under the summary reporting program, a controversial system that recently ended this year.
It said: “Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE (Manufacturer and User Facility Device Experience).”
The FDA hopes that by focusing more attention to the matter by making reports available to the public, with increased communication with the medical field, it can help to better understand and evaluate the pattern of BIA-ALCL.
The FDA will be attempting to reach more medical professionals, (such as dermatologists, gynecologists, internists, and pathologists) to make them aware of the risks associated with breast implants. The agency has procured a letter, which can be accessed here, that outlines discussing the risk of BIA-ALCL with patients and calls to action should the patient show signs of it.
The agency is encouraging medical professionals to file a report with MedWatch, its public safety information and adverse event reporting program.