Dec 16, 2019
Following the Allergan breast implant recall, two Florida women have filed a $5 million lawsuit against the implant maker, alleging Allergan should pay for all surgical costs associated with removing the devices. Textured Allergan implants were the subject of a recall after the US Food and Drug Administration (FDA) uncovered reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that were strongly associated with the company’s implants.
Although the FDA did not advise women to have the implants removed unless they showed signs of BIA-ALCL, doing so leaves patients with implants in their bodies that could cause potentially fatal cancer. Furthermore, the risk of developing cancer increases the longer the implants are left in.
At Patterson Dahlberg, we have seen how the actions of medical device makers put patients at risk of serious, life-threatening consequences. We have helped patients whose lives have been drastically changed by a device they thought would be beneficial and we have fought to hold those device makers accountable for putting profits ahead of patient safety.
Women Left with “Horrible Choice”
The lawsuit was filed by two women, Kelli Russell and Amy Ferrera. Russell had the Allergan textured implants put in as part of reconstructive surgery following a double mastectomy due to a cancer diagnosis. Ferrera received the implants as part of breast augmentation surgery in December 2009.
Allergan reportedly said that it would provide similar smooth implants for women who have the textured implants and want them removed. The implant maker also offered to reimburse patients up to $1,000 for diagnostic fees and up to $7,500 in surgical fees that are incurred as part of diagnosing and treating the BIA-ALCL.
Allergan will not pay for implants from a different company and has not said it will pay for all expenses associated with removing the recalled devices. According to the women’s lawsuit, out-of-pocket costs of having the revision surgery would be between $3,000 and $9,000 dollars, before factoring in time away from work.
The women are left with a “horrible choice: remove the Implant and pay surgical and associated costs out of their own pocket or live in fear knowing that their Implants have increased their risk of developing cancer.”
The lawsuit alleges breach of implied contract and violations of Florida’s Deceptive and Unfair Trade Practices Act.
Other Allergan Lawsuits Filed
The lawsuit filed by Russell and Ferrera is not the first related to the Allergan textured breast implant recall. A similar lawsuit filed in August 2019 also seeks to cover the costs associated with revision surgery. Meanwhile, a September 2019 lawsuit alleges two women developed BIA-ALCL after receiving Allergan’s textured breast implants.
FDA Proposes Black Box Warning on Breast Implants
Earlier in October 2019, the US Food and Drug Administration (FDA) proposed a black box warning for breast implants. A black box warning is the strongest warning a medical device or pharmaceutical drug can carry. So far, the FDA has issued only its draft guidance and is seeking public comments.
The proposed black box warning would include information about BIA-ALCL, saline-filled and silicone gel-filled implants, and the risks associated with breast implants. The box will also warn that breast implants are not intended as lifetime devices and that the chances of complications increase the longer an implant remains in the patient.
Allergan Breast Implant Recall Linked to BIA-ALCL
Allergan Biocell textured breast implants were recalled following reports of BIA-ALCL, an incredibly rare but potentially fatal cancer. The Biocell textured implants were linked to 481 of 573 unique cases of BIA-ALC and 12 of the 13 fatalities for which the implant maker was known.
According to the FDA, the risk of BIA-ALCL is approximately 6 higher with Allergan Biocell textured breast implants than with textured implants from other makers.
Attorneys Fighting Against Makers of Defective Devices
Companies that manufacture defective devices that harm patients must be held accountable for their actions. Patients whose lives and health are put at risk by corporate greed must be compensated for the harm done to them, through no fault of their own. The women who have received Allergan textured implants are stuck in a terrible position of having a device in their body that at some point could cause fatal cancer.
The attorneys at Patterson Dahlberg have spent years fighting against large companies that harm innocent people. Our team has successfully taken on some of the biggest medical device makers in the world. We have the knowledge, skills, and resources to successfully represent the people hurt by medical device makers. Our attorneys conduct meticulous investigations into every claim and will give you the personalized attention you deserve.
If you or a loved one has been harmed by an Allergan implant, contact an attorney at Patterson Dahlberg today for a no-obligation consultation.