PHOENIX (3TV/CBS 5) -- A whirlwind of information over breast implants linked to cancer has left women concerned and trying to sort through information.

After announcing earlier this year they would NOT issue a recall, the FDA is doing an about-face by announcing medical device maker Allergan has agreed to recall it's BIOCELL textured breast implants.

[WATCH: Scottsdale doctor gives insight on cancer caused by textured implants]

Adding to the confusion, the cancer is rare, but we are seeing a sudden increase in reported cases and deaths.

Now, Allergan is offering to replace textured implants with smooth implants. But, is that medically necessary?

Of the 531 cases of BIA-ALCL reported worldwide since 2011, Scottsdale's Dr. Joseph Berardi of Berardi Aesthetics & Plastic Surgery has treated four of the patients.

[PREVIOUS: Are doctors missing cancer caused by breast implants? A survivor's story]

For women who are concerned, Berardi says, "Information is power. You bring it [concerns] to your doctor and say, 'Are you aware of BIA-ALCL, and could this be BIA-ALCL?.'"

To help inform women, CBS Investigates collected information from Dr. Berardi, the FDA and the American Association of Plastic Surgeons.

[LEARN MORE: Breast implant illness]

With a list of recalled devices, links to sources are provided at the end of this article.

What is BIA-ALCL?

BIA-ALCL is a rare cancer of the immune system (lymphoma). It is not breast cancer. The cancer forms in the capsule (scar tissue) around the implant. Cancer starts in the scar tissue and can spread.

How common is BIA-ALCL?

BIA-ALCL is rare, but there's been a recent surge in reported cases.

Since 2011 through early 2019, the FDA says there were 473 cases reported with nine deaths.

Following increased attention earlier this year from FDA meetings focusing on breast implant safety, the number of reported cases jumped to 573 cases with 33 deaths, a 266 percent increase in the number of deaths.

What are the common symptoms of BIA-ALCL?

  • Fluid building up around the implant causes breast enlargement and asymmetry. One breast appears larger than the other.
  • Hardening of the scar tissue around the implant. This is known as capsular contracture.
  • Additional symptoms can include a lump in the breast or armpit.
  • Average onset is eight to 10 years after implantation.

Do all breast implants cause BIA-ALCL?

That is still up for debate. Texturing linked to cancer is on the exterior shell of the implant. It does not matter if the implant is saline or silicone. The FDA says Allergan products with a BIOCELL textured surface (shell) are six times more likely to cause cancer than implants made by other manufacturers. Information is limited because Medical Device Reports or MDRs submitted to the FDA do not always include the patient's history, including the types of implants they had over the years.

What is the treatment for BIA-ALCL?

Treatment includes surgery to remove the implant and the scar tissue surrounding the implant. If cancer spreads outside the capsule, patients may require treatment with chemotherapy and/or radiation therapy.

Are there tests for BIA-ALCL?

Yes. Fluid around the breast can be drained and tested.

When it comes to testing, the FDA recommends:

“Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.”

Should women remove their implants?

The FDA and Dr. Berardi both say no. There are a few reasons. This is rare cancer. Out of the estimated 35 million women who have implants, there are fewer than 600 cases reported worldwide. However, with additional awareness now focused on cancer, there's a sudden increase in the number of cases reported.

Unlike some other cancers, BIA-ALCL appears to make its presence known with swelling, pain and fluid accumulation. Because there are dangers associated with any surgery, Dr. Berardi says women should be aware of any changes in their breast. However, removing the implant is unnecessary unless a woman shows symptoms.

Will Allergan pay to remove textured implants?

Allergan is offering to replace the BIOCELL textured implants with smooth implants. They will only cover the cost of the implant. Allergan will NOT cover the cost of the surgery. This offer is good for 2 years until July 24, 2021.

Women who keep their textured implants and develop cancer are covered for $1,000 in diagnostic fees and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL.

What devices are being recalled?

Allergan Natrelle Saline-Filled Breast Implants (formerly named McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:

  • 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 named 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)

Helpful Resources:

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(3) comments

CME

To the two ignorant men who made the comments above: Not all women had elective surgery for breast implants. There are a lot of breast cancer survivors whom have this type of implant. You have no idea what they have gone through or are going through, then to have this situation occur to worry them more.

Both of you need to shut your mouth.

JustinP

We've known about breast implants causing multiple health issues for decades now. Just because some company says 'oh, but ours are safe' does not make it so. Be happy with what you have and spend your money on other things.... If a liberal, on supporting the illegal aliens you want up here. If a conservative, on continuing to support the poor and weak throughout the world with their big gifts to charity.

Dean

I have a better idea. Do not mutilate your body for any reason. What God gave you is what you should admire.

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