Money cannot buy you happiness, but it can pay for a cosmetic surgery. What if the cosmetic procedure ends in a mess and affects your health and life? Let’s talk about breast implantation, breast implant side effects, and breast implant lawsuits.
Breast implantation is a cosmetic procedure where prostheses are surgically placed inside the breasts. Who gets breast implants? The procedure is most commonly done by celebrities to enhance the beauty or cancer patients after mastectomy for breast cancer. The cosmetic reasons for breast implantation are mentioned below.
- Restoring a previous breast size
- Correcting asymmetrical breasts.
- Affirming your gender
- Boosting confidence
Different Types of Breast Implants
Breast implants are shells filled with sterile saline or silicone gel that support breast augmentation. There are two different types of breast implants based on the material of the implant. They are
- Saline breast implants
- Silicone breast implants
Saline breast implants are hollow, silicone implants filled with sterile saline injections. The saline may be prefilled or filled during the implantation procedure. They have either smooth or textured shells and come in various sizes.
Silicone breast implants have a silicone outer shell that is filled with silicone gel. They have the consistency of a gummy bear like gel and are available in different sizes with either smooth or textured shells. Majority of the women prefer silicone breast implants as they give a more natural feel and comfort.
Breast Implantation Procedure
The procedure is under either intravenous sedation or general anesthesia depending upon the health of the patient and the implantation type. An incision is made to for implantation. Which is usually done in inconspicuous areas to minimize visible scarring.
The incision can be made
- On the crease under the breast (inframammary)
- Under the arm (axillary)
- Around the nipple (periareolar)
After making the incision, the surgeon separates the breast tissue from the muscles and connective tissue of the chest. The surgeon inserts the implant either under the pectoral muscle, called submuscular placement or directly behind the breast tissue, over the pectoral muscle, called submammary/ subglandular placement. After implantation, the incisions are closed with sutures.
Can breast implants last a lifetime?
How often breast implants should be replaced? Implants are not for a life-time and they need to be replaced every 10-20 years. Some individuals may require a removal or replacement with in 5-8 years due to some product defects or side effects of the implant.
The life of a breast implant depends upon several factors like size, type, quality and shape of the implant, doctor’s skill, and the overall health of the patient.
Let us find some circumstances due to which the breast implants are either replaced or removed.
Certain breast implants may develop capsular contracture, or hardened scar tissue around the implant. This in turn causes tightness, pain, tenderness, and other complications in the breast.
Can breast implants leak? The answer is yes.
Saline rupture is the condition where a tear occurs in the saline breast implants. When breast implants rupture, it causes leakage of the saline in the implant. The leaked saline gets reabsorbed by the body. Saline rupture causes the breast to lose its size and shape.
Silicone rupture occurs in certain silicone breast implants and the gel often stays inside the implant or surrounding scar tissue. Hence this type of rupture is called as silent ruptures as they do not cause any visible symptoms in most of the women.
Breast implant rupture lawsuits arise when there is either a saline or silicone rupture in the implants.
Rippling and palpability
When an implant develops ripples or wrinkles, it is said to be rippling. When you touch your breast, you can feel these ripples which is called palpability.
Change in position
Breast implants can change in its position causing sagging or deformed shape. Weight gain or weight loss can cause change in the position of the implant.
Are breast implants safe?
The safety of breast implants and the procedure depends upon the quality of the product implanted, age and health condition of the patient and efficiency of the procedure.
The focus of this blog which is on breast implant class action lawsuit is pointing that breast implantation is not safe every time. Through this blog we cannot say which breast implants are the safest or recommend a particular product.
Breast Implant Side Effects
The below mentioned are some of the common breast implant complications associated with breast implantation.
- Breast Pain
- Breast cancer
- Breast tissue atrophy
- Delayed wound healing
- Calcification/Calcium Deposits
- Chest Wall Deformity
- Requirement for additional surgeries
- Problems in breastfeeding
Breast Implant Illness (BII)
Several different symptoms that appear after obtaining breast implants are referred to as breast implant sickness (BII). BII is also called autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Any type of breast implant, whether it has a smooth surface, a textured surface, a round shape, or a teardrop shape, can cause BII.
BII affects the musculoskeletal system and cognitive ability and, in some cases, affects the entire body, exhibiting systemic symptoms. The types and severity of symptoms in BII vary from one individual to the other.
- Joint pain
- Muscle pain
- Brain fog
- Dry eyes or low vision
- Hair loss.
- Skin problems
- Muscle weakness
- Anxiety and depression
- Memory loss
- Trouble concentrating
- Chronic pain
There is no official medical diagnosis of BII, and the condition is yet to be studied on a deeper level. In some cases, only the removal of the breast implants helps the patient in overcoming the symptoms.
Breast Implant–Associated Anaplastic Large Cell Lymphoma
Breast Implant–Associated Anaplastic Large Cell Lymphoma, also known as BIA-ALCL is a rare lymphoma affecting women with breast implants. A small percentage of individuals with textured breast implants are reported to develop BIA-ALCL.
This type of non-Hodgkin lymphoma develops in scar tissue and fluid near the breast implant and may metastasize to other parts causing the death of the patient.
Research studies indicate that a chronic infection around the implant stimulates the immune system, and over time, it becomes cancer. There are also studies pointing to the relationship between the genetics of an individual and BIA-ALCL.
Soreness, breast growth, asymmetry, lumps in the breast, lumps in the armpit, overlaying skin rashes, hardness of the breast, and fluid collection in the breast are some of the common symptoms associated with BIA-ALCL. The symptoms appear at least a year after having an implant and, typically, 8 to 10 years afterward the implantation.
Do you qualify for a breast implant lawsuit?
To qualify for a breast implant lawsuit, you should meet the following requirements.
- You had textured breast implants placed.
- You are affected by Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or another kind of cancer.
- You underwent a revision procedure, or the implants were removed.
Allergan Breast Implant Lawsuits
Allergan Inc is a leading manufacturer of saline and silicone breast implants that faces numerous lawsuits for product liability.
The FDA initially discovered a connection between breast implants and anaplastic large cell lymphoma (ALCL) in 2011. Breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, was added to its list of T-cell lymphoma subtypes by the WHO in 2016.
The FDA stated in 2017 that textured implants had a greater correlation with BIA-ALCL than smooth implants. On July 24, 2019, the Food and Drug Administration conducted research and announced that they had found a link between Allergen’s textured implants and BIA-ALCL.
As per the FDA, out of the 573 breast implant BIA-ALCL cases reported globally, 481 cases involved Allergan Breast Implants. In cases where the model is known, Allergan devices account for more than 90% of breast implant cancer fatalities. 33 fatalities have been linked to BIA-ALCL.
Investigations revealed that Allergan’s BIOCELL Natrelle textured implants have six times higher rates of BIA-ALCL cancer development than other types of implants or tissue expanders, despite BIA-ALCL having occurred in some individuals with smooth implants.
In December 2018, Allergan stopped supplying its textured implants in all nations of the European Union, Brazil, Australia, and Israel. Allergan’s manufacturing license was revoked by HealthCanada in May 2019, but the corporation took no immediate action in the United States.
Allergen Breast Implant Recalls
Following a request from the FDA in July 2019 to cease the product sale in the United States, the business announced a global recall for multiple brands of its Biocell textured breast implants.
Recall alert: At FDAs request, Allergan is recalling all of its Biocell textured breast implants to protect women from the risk of breast implant associated anaplastic large cell lymphoma. Affected products include both silicone and saline-filled implants https://t.co/EyBP0h4SCd pic.twitter.com/aysTFz5eSw
— U.S. FDA (@US_FDA) July 24, 2019
The products covered in the recall are as follows.
- Natrelle Saline-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 133 Tissue Expander with Suture Tabs
An FDA warning letter was issued in May 2020, not long after AbbVie, a pharmaceutical company acquired Allergan. Allergan was charged with failing to finish post-market safety studies even though the implants had been recalled ten months earlier.
According to the FDA warning letter, Allergan had been obligated to conduct a sizable safety study as part of the approval of the Natrelle implant but had fallen short in patient recruitment and data collection.
Allergen Breast Implant Cancer Lawsuit
A New Jersey state court decided in June 2021 that Allergan must respond to the allegations against them in a combined class action lawsuit.
Allergan Biocell textured breast implant products liability litigation was consolidated into MDL No. 2921 in the US. District Court for the District of New Jersey under the presiding judge Hon. Brian R. Martinotti, U.S.D.J. and Hon. Edward S. Kiel, U.S.M.J. Hundreds of lawsuits are filed by the affected implant recipients, and the litigation is still pending.
Despite the FDA recall, neither Allergan nor the FDA is advising women who have Biocell® breast implants to have them replaced or removed.
The smooth breast implant products from Allergan will be substituted for the Biocell® textured implants at no cost, according to the company.
To remove the BIA-ALCL cancer risk brought on by the initially placed Biocell® textured breast implants, however, will need surgical and diagnostic costs, medical monitoring, and diagnostic tests. The expense of the procedure to remove or replace the implants would not be covered by the company, though.
Liability Against Allergen
The plaintiffs accuse the following violations against Allergen while selling their breast implants.
- Allergan violated state law by failing to inform customers of the risks associated with producing BIA-ALCL.
- Allergan had breached the Federal Food, Drug, and Cosmetic Act (FDCA) constitutes negligence per se.
- Hazardous silicone particles are among the detritus found in the implants. As a result, Allergan also transgressed the FDCA’s ban on selling tampered goods.
- Allergan failed to conduct Post-PMA Clinical Studies about the long-term effects of their products.
After the FDA pointed out that Allergen’s public outreach strategies were insufficient to let women know about the recall, the company initiated a focused social media and online outreach drive to track down and get in touch with patients who might have gotten Biocell textured breast implants and tissue expanders.
Dow Corning Breast Implant Lawsuits
Dow Corning is another breast implant manufacturer under litigation related to side effects caused by the implants. In 1995 thousands of plaintiffs accused that that company was hiding information about the health risks of silicone used in their breast implants.
The plaintiffs suffered a host of health problems like hardening of the breast tissue, implant rupture and disabling disorders that resemble autoimmune disorders like lupus. Several breast implant rupture lawsuits have been filed against Dow Corning by the victims.
Responding to the litigations raised by the affected women, Dow Corning established a $3.2 billion breast implant settlement fund.
A final “Premium Payment” from the bankruptcy settlement is available to women who had Dow Corning breast implants (and their heirs if the claimant is deceased) and who were authorized for either a Rupture and/or Disease claim.
The Claimants’ Advisory Committee for the Dow Corning Bankruptcy requests that ladies who had Dow Corning breast implants get in touch with the claims office immediately to inquire about their payment status.
The final deadline for the affected women to be paid was September 17, 2022, if their claim number is displayed on the claims office website. By September 17, 2022, the claims will be closed and permanently blocked if the payments have not been claimed.
As of April 1, 2022, the FDA documented 1,130 BIA-ALCL cases worldwide, 505 of which originated in the United States. The malignancy mortality cases are 59, which includes 14 Americans. The FDA and the American Society of Plastic Surgeons are still collaborating to determine the precise cancer risk associated with breast implants.
Adding fuel to the fire, the FDA has come up with another study report. On September 8, 2022, the FDA issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas associated with breast implants.
Once the research on breast implant-associated malignancies is completed, it will have a greater impact on breast implant lawsuits in the United States.
Cancer is not the only complication of breast implants. Besides the obvious risks associated with surgery, there are associated rare forms of auto-immune diseases that are still being researched. The FDA also recommends an annual check-up to check for leaks.
Typically, people who are obtaining implants may not be aware of the danger of BIA-ALCL.
Let’s forget the product defects and the breast implant lawsuits right in front of us and ask ourselves.
Do I need to be beautiful with breast implantation? Is the risk of getting cancer worth it?
The US FDA now does not advise implants for people who already have cancer or precancer of the breast tissue. Breast implants for those who have been diagnosed with breast cancer come with separate guidelines.
Breast implants are done only for aesthetic reasons and due to the body insecurities imposed by society. When a procedure is done not for any medical emergency, it is worth thinking twice before you make a choice.
The decision is yours…
We are waiting to hear your views on getting breast implants and other cosmetic procedures. Let’s meet in the comment section.
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•Breast Implant Illness (BII)
•Breast Implant-Associated Anaplastic Large Cell
•Requirement for additional surgeries#breastimplants #lezdomedlegal pic.twitter.com/xJizT1jqif
— LezDo MedLegal (@LezDoMedLegal) October 28, 2022