We hear about recalls all the time on the news and usually, the problem requires an easy fix: your car needs a new part, you take it to the dealership. Your chair has a poorly constructed mechanism, you fill out a form and send it to the manufacturer for a refund. Your lettuce is contaminated with e.coli, so you return it to the grocery store and pick up a bag of Oreos instead. Simple enough, right? But what if you have a medical device that has been recalled? You can’t just make a short visit to your doctor’s office to remove it and it’s really scary to keep it in your body. It seems like enough studies and quality assurance tests should have been conducted to keep patients safe, right?
This is exactly the problem that women with allergan textured breast implants are facing. On July 24, 2019, the FDA requested that Allergan recall these products because of the increased risk of a cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). But there are a few problems with this story: 1) the FDA’s reporting system inadequately reported breast implant complications for years, 2) medical device makers and authorities have known about cancer being linked to textured breast implants for almost a decade before it was recalled, 3) other countries recalled this product months before the U.S., and 4) women were never warned that this product held a higher risk of cancer than other breast implants available on the market.
What is BIA-ALCL?
(BIA-ALCL) is a cancer of the immune system and NOT breast cancer and is found in the scar tissue and fluid near the implant. Smooth implants sometimes have a bad reputation for moving around freely, so textured implants were created to eliminate this issue. Unfortunately, some medical professionals believe that its the texture that causes tissue irritation and an allergic-like reaction that stimulates cancer cell growth.
If a patient is diagnosed with BIA-ALCL, the treatment tends to involve the removal of the scar tissue and implant and usually doesn’t require chemotherapy or radiation treatments.
What You Should Know
- 573 cases of BIA-ALCL have been reported worldwide, 481 occurred in women who have had Allergan’s BIOCELL textured implants
- 33 patients have died due to this type of cancer
- Call your plastic surgeon to see if your breast implants have been recalled
- The main warning signs that were reported were fluid build-up, pain and soreness, or a lump or growth near the implant. If you suspect that something about your implant has changed, make an appointment with your doctor immediately.
- Allergan textured implants account for about 5% of the U.S. breast implant market, but that still means that hundreds of thousands of American women may have them. Of those women, textured implants were used primarily for reconstructive surgeries for patients who previously had breast cancer.
- Of the 573 reported BIA-ALCL cases reported, 276 of those were from the U.S. (56%).
- The women who were diagnosed with BIA-ALCL had their implants anywhere from one to 20 years. The average time span for diagnosis was nine years.
Problems with “The System”
Reporting adverse effects and a lack of medical device registry has long been a glaring flaw in the FDA. This problem is glaringly obvious in this case involving textured breast implants. In 2017 in the US, “the Food and Drug Administration (FDA) ordered companies to file adverse events individually, rather than allowing them to report huge numbers of cases in one go,” reports The Guardian. “This led to a dramatic rise in the number of reports linked to breast implants – from 353 in 2016 to 4,651 in 2017, and 8,352 in the first six months of 2018.”
Next, BIA-ALCL was first diagnosed in 1997 and health authorities first linked textured implants to cancer in 2011. In October 2017, a study found that “The highest estimated risk as expressed as cases of ALCL per number of implantations was found for the Allergan Biocell texture at 1 in 3817 (95%CI 2718 to 5545) as compared with Silimed Polyurethane at 1 in 7788 (95%CI 3042 to 28581) and Mentor Siltex texture at 1 in 60631 (95%CI 10882 to 2397471). Higher surface area textured implants are therefore shown to significantly increase risk of BIA-ALCL in Australia and New Zealand,” cites the Association of Breast Surgery.
Unfortunately, even with the knowledge of BIA-ALCL and the various studies conducted, women weren’t warned that textured implants had an increased risk of cancer… six times higher! And did you know that allergan textured breast implants were taken off the market in Europe in December 2018, seven months before it was recalled in the U.S.?
Have You Been Diagnosed with BIA-ALCL?
If you’re like breast cancer survivor Lory Daddario and had known about the higher risks of cancer with a textured implant, you would have chosen a different option. Lory was diagnosed with BIA-ALCL in 2017, two years after having reconstructive surgery involving textured implants. “Had we known of the risk, we would have never opted for an implant,” tells Lory to CBS News. Lory feels that this recall doesn’t go far enough. “One person with this lymphoma is too many.”
If this sounds terribly familiar, then our team at Periscope Group would love to hear your story. allergan knew of the increased risks for cancer, and yet patients were not informed. Your health was put in danger and you weren’t given the proper information to make an educated decision concerning your care. It’s time to hold billion-dollar medical device companies accountable for their actions. Call Periscope Group today at (800) 511-3838. We want to help you in any way that we can.