Jandali Plastic Surgery is committed to providing the highest quality of care and attention to its patients, and this includes staying informed about any recalled implants used in breast augmentation or reconstruction procedures.
Breast implants are a popular choice for women looking to enhance their appearance or undergoing reconstructive surgery after a mastectomy. However, in recent years, some breast implants have been recalled by the FDA due to safety concerns.
A breast implant recall occurs when a product is found to have defects or issues that may cause harm to patients. This can include problems such as being prone to early rupture/leaks, causing cancer, or having mold growth within the implant.
What Type of Breast Implants have been Recalled?
The most recent breast implant recall occurred in 2019, when the U.S. Food and Drug Administration (FDA) requested that the manufacturer Allergan recall its BIOCELL textured breast implants and tissue expanders. The FDA cited a link between the textured implants and an increased risk of a type of cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
Allergan complied with the request and issued a voluntary recall of the affected products. Patients who had the recalled implants were advised to speak with their plastic surgeons about the risks and potential next steps, such as monitoring or removal of the implants.
Other breast implant recalls have occurred in the past, including recalls of saline implants in the 1990s and silicone implants in the 2000s. In some cases, recalls have been initiated by the manufacturers themselves, while in other cases, the FDA has taken action to request recalls.
Recalled Breast Implants Linked with Lymphoma of Breasts
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of cancer that has been linked to textured breast implants, particularly those manufactured by Allergan. In 2019, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders due to the increased risk of BIA-ALCL.
BIA-ALCL is not breast cancer, but rather a cancer of the immune system that can develop in the scar tissue (capsule) surrounding breast implants. The cancer is typically slow-growing and treatable, but can be fatal if left untreated. Symptoms may include pain, swelling, or lumps in the breast area, as well as fluid buildup around the implant.
The link between Allergan implants and BIA-ALCL was first identified in 2011, and since then, there have been hundreds of cases reported worldwide. According to the FDA, as of September 2019, there had been 573 cases of BIA-ALCL reported globally, including 33 deaths. Of these cases, 481 were linked to Allergan implants. More recent studies have shown that the risk with these recalled Allergan 410 implants (often called “gummy bear implants”) can be up to 1 in 300 patients for developing ALCL.
Why Do Recalled Breast Implants Cause Cancer?
The exact cause of BIA-ALCL is not fully understood, but it is thought to be related to the texture of the implants. Textured implants have a rough surface designed to help the implant adhere to surrounding tissue, but this texture may also encourage the growth of bacteria and inflammation, which can lead to the development of BIA-ALCL.
While the risk of developing BIA-ALCL is relatively low, it is still a serious concern for anyone considering breast implants. Patients with Allergan implants should be aware of the potential risk and talk to their plastic surgeon about monitoring for symptoms or potentially removing the implants.
In addition to the Allergan recall, the FDA has also recommended that plastic surgeons do not use textured breast implants and tissue expanders from any manufacturer until more is known about the risk of BIA-ALCL. The FDA is also requiring manufacturers to include a warning about the risk of BIA-ALCL in the labeling of their products.
Treatment Options for Recalled Breast Implants in Connecticut
For patients who have received recalled breast implants, the first step is to schedule an appointment with Dr. Jandali. He will discuss the options available for treatment.
In some cases, the implants may need to be removed and replaced with new smooth implants. Sometimes, a capsulectomy is performed to remove all the scar tissue and capsule from around the recalled breast implant. In other cases, the implants may be left in place and monitored for any signs of complications.
DIEP Flaps after Removal of Recalled Implants in Breast Reconstruction
Many women who have undergone mastectomy after breast cancer treatment have textured implants that are recalled. This is due to the fact that textured implants actually gave a better cosmetic result after mastectomy because they had a better shape and less rippling. The downside is that these implants are associated with BIA-ALCL.
For women who desire removal of their recalled breast implants, a great option is natural reconstruction without implants using DIEP flaps. DIEP flaps are performed by transplanting skin and fat from the lower abdomen to the breasts. This is the same tissue that is removed and discarded during an abdominoplasty (tummy tuck). The tissue is instead moved to the chest and shaped in a natural soft breast.
Frequently Asked Questions
What does it mean if my breast implant is recalled?
A recall means that the implant manufacturer, possibly with the recommendation of regulatory authorities, has decided to remove a product from the market due to potential health risks or complications.
What symptoms can be associated with recalled breast implants?
Symptoms may vary but can include changes in breast shape or size, discomfort in the breast area, redness or swelling around the implant, fluid accumulation, and flu-like symptoms.
Why is it crucial to address recalled breast implants?
Addressing recalled implants is vital due to potential health risks, increased chances of complications, and the anxiety and stress knowledge of having a recalled implant can cause.
What should I do if my breast implant is recalled?
If your implant is recalled, schedule a consultation with your doctor to discuss potential risks, symptoms, and the best course of action moving forward, which could involve monitoring or removal and replacement of the implant.
What are the options if my implant is recalled and I don’t have symptoms?
If you don’t have symptoms, your doctor might suggest continued monitoring for any changes. However, removal and replacement of the implant can be considered based on the specifics of the recall, your personal preference, and your overall health.
Schedule an Appointment with Jandali Plastic Surgery in Connecticut
Jandali Plastic Surgery is committed to providing its patients with the highest quality of care and attention. If you have received recalled breast implants, it is important to schedule an appointment with Dr. Jandali to discuss your options for treatment. Dr. Jandali will be able to perform an examination and determine if your implants are the type that have been recalled, and will discuss the risks and benefits of replacement surgery or monitoring.
It is also important to understand that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare but serious condition that has been linked to certain types of breast implants. If you are experiencing symptoms such as swelling, pain, or lumps in the breast, it is important to seek medical attention immediately.
