[Updated July 2019 to incorporate the just announced worldwide recall of Allergan textured breast implants.] In February, the Food and Drug Administration (FDA) sent a letter to healthcare professionals warning of the association between breast implants and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA – ALCL).
According to the letter, “The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant. We want all healthcare providers to be aware of BIA – ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA – ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”
In July, 2019, the FDA requested that Allergan recall their BIOCELL textured breast implants.
What is Anaplastic Large Cell Lymphoma (BIA – ALCL)?
BIA-ALCL is a type of cancer that occurs when white blood cells – called T-cells – develop abnormally. It is treated with chemotherapy and steroids. Sometimes doctors also use radiation treatment or stem cell therapy. ALCL can be fatal if untreated but patients receiving timely treatment usually report full remission.
Unlike breast cancer, BIA-ALCL doesn’t form in the tissue of the breast. Instead, it forms in the fibrous scar called a capsule that develops around the implant.
The FDA has been warning about the risks of Anaplastic Large Cell Lymphomas since at least 2011. That year the agency published a comprehensive report on safety of silicone gel breast implants.
Back then, the agency said, “Women who receive silicone gel-filled breast implants for augmentation do not appear to be at increased risk of developing breast cancer. In fact, studies suggest they may be at average or even lower risk – with some estimating a risk reduction of 10 to 50 percent.”
There was one important caveat to that report, however. The agency noted 60 cases worldwide of Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. That wasn’t enough data back then to take action. Instead the FDA simply reported that some in the scientific community thought there could be a link.
Fast forward to 2019 where we now have far more data. In February, the agency estimated the incidence of BIA – ALCL somewhere between a high of 1 patient per 3,817 to a low estimate of 1 in 30,000. [An estimated 1.5 million women receive breast implants each year worldwide.]
In an effort to improve patient safety, device manufacturers such as those companies that make breast implants are required to file “medical device reports.” These reports are used to document serious adverse events associated with a medical device, as well as product quality issues and therapeutic failures. Doctors are also encouraged to file these reports.
With the advent of mandatory reporting, the FDA has more data to analyze.
As of February 2019, the FDA says it has received 457 unique medical device reports indicating anaplastic large cell lymphomas in women with breast implants. The agency believes that 9 women have died from their cancer.
It’s not just large cell lymphomas. Since the FDA has been more carefully monitoring breast implant safety, the total number of injuries has risen dramatically. The number of suspected breast implant injuries jumped from an average of fewer in 2016 to 4,567 events in 2017 and at least 8,242 in the first half of 2018.
Many physicians don’t know of the link between BIA-ALCL and breast implants. Now that the warning letter has been issued, we anticipate many more reports will be filed. In other words, the incident rate is probably much higher than even the above reports.
History of Breast Implant Regulation
To understand the current lack of data and the sudden interest in the link between cancer and breast implants, some history is needed.
Breast implants were first marketed in the United States in 1962. That year Timmie Jean Lindsey became the first woman to receive breast implants in the United States. At the time implants were not regulated.
In 1976, Congress amended the Food, Drug and Cosmetic Act to include medical devices. Breast implants were not considered high risk devices, however, meaning manufacturers and importers merely had to comply with general controls and performance standards.
It wasn’t until the early 1980’s that safety concerns arose with breast implants, particular those made with silicone gel. The FDA’s nascent reporting system identified frequent complications (although not cancer).
In response to these reports, the FDA elevated breast implants to Class III, a higher risk category. Makers of the implants needed both premarket approval before selling their products and had to demonstrate their products were safe and effective.
Because of quality control issues involving leakage and ruptures, the FDA removed all silicone gel filled breast implants from the market. Many women filed lawsuits after having complications necessitating additional surgeries.
With silicone gel breast implants off the market, saline filled implants became the product of choice. (Silicone breast implants were largely off the market between 1992 and 2006.)
In 1999, an important comprehensive study was released by the Institute of Medicine. The study found a clear distinction between complications from breast implants and what they termed “systemic health effects.”
While breast implants were often associated “local complications” such as rupture, pain, infection and disfigurement, there was no evidence that breast implants caused systemic health problems such as cancer.
The report ultimately resulted in the FDA reapproving silicone gel implants in 2006. It wasn’t until then that the government required medical device reports be filed for complications arising from breast implants.
2019 Breast Implant Recall by Allergan
At the request of the FDA, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue extenders.
The specific Allergan products subject to the recall are:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
Simultaneously with recall, the FDA released new cancer figures showing 573 cases of anaplastic large cell lymphoma, with 481 attributed to Allergan’s implant. 33 of those cancer patients reportedly died. France and Canada have issued similar bans and Australia’s Therapeutic Goods Administration is contemplating similar action.
Despite the recall, the FDA is not advocating woman have their implants removed unless they are experiencing problems. The agency’s principal deputy commissioner, Dr. Amy Abernarthy, said,
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product [Allergan] appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health. The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011 and, at that time, communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease. Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA… Based on new data, our team concluded that action is necessary at this time to protect the public health. We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast. If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
It should be noted that Allergan undertook the recall voluntarily and pledged that patient safety remains their top priority.
Allergan is the largest manufacturer of textured implants in the United States but will the recalls stop there? In March 2019 the FDA issued a stern warning letter to implant maker Sientra. The agency says the company didn’t properly conduct a longterm safety study of women with their breasts implants.
Symptoms of BIA-ALCL (How Do I know if I Have ALCL?)
According to information published by UT Southwestern Medical Center, the most common symptoms of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is excessive fluid buildup around the implant. (Remember, this type of cancer develops in the scar tissue surrounding the implant. The fluid buildup may cause swelling, pain or lumps in the breast or armpit.
The Medical Center reports the onset of symptoms mostly occurs between 3 and 14 years after the implant, although we know from a recently filed lawsuit that a woman developed BIA – ALCL just two years after her breast implants.
If you develop symptoms, always call your doctor immediately. If your doctor diagnoses anaplastic large cell lymphoma cancer, call us. If caught in time, ALCL is treatable.
Most of the anaplastic large cell lymphoma cancer cases appear to be related to textured-surface breast implants. The FDA reports that less than 10 percent of women diagnosed with BIA-ALCL had smooth-surfaced implants.
Smooth-surface implants are commonly used for cosmetic breast surgery. Textured surface implants are more used for both reconstructive and cosmetic surgeries.
The American Society for Aesthetic Plastic Surgery Inc. (ASAPS) estimates that in the United States about 550,000 breast implants are placed each year. Approximately 13 percent of these implants are textured-surfaced.
And what about the women diagnosed with BIA – ALCL? 93% of the women diagnosed are disease free when tested three years after treatment.
Who Sells Breast Implants Today?
The four FDA approved makers of breast implants today are:
- Allergan (formerly known as Inamed or McGhan). The company markets a product called Natrelle in both smooth and textured versions.
- Mentor World Wide LLC, (a Johnson & Johnson company). Mentor produces smooth and textured breast implants under the names MemoryGel and MemoryShape.
- Sientra, Inc. The company makes both smooth and textured implants.
- Ideal Implant Incorporated. The company only makes smooth implants.
(Already there are lawsuits against Allergan and Mentor World Wide for BIA – ALCL.)
Early Breast Implant Lawsuits
As noted above, there were significant reported quality control issues with breast implants. Although cancer was far from anyone’s mind in the earlier years, many women were suffering from leakage, disfigurement and infections.
The first reported lawsuit occurred in 1977. A Cleveland woman settled for $170,000 from Dow Corning after claiming her implants ruptured requiring additional surgeries and pain and suffering.
In 1984, Maria Stern won $211,000 in damages and an additional $1.5 million in punitive damages. She claimed that silicone breast implants manufactured by Dow Corning caused her to suffer autoimmune disease. The evidence in that case remains sealed.
At the trial, jurors learned of internal documents from Dow Corning showing they had knowledge of the high rupture rate of their implants.
In December 1990, Congress held hearings on the safety of breast implants. The committee was frustrated because some of the evidence was still sealed from the 1984 case. Six months later Dow Corning released 329 studies to the FDA. Those records included a confidential internal memorandum acknowledging that the company had known for decades that silicone gel often leaked from their implants.
In December 1991, a San Francisco jury awarded Mariann Hopkins $7.3 million after her Dow Corning implants ruptured causing connective tissue disease. More evidence from Dow Corning surfaced, some of which had never been provided to the FDA.
PBS reports that by 1993, 12,539 lawsuits were filed against Dow Corning over allegedly defective breast implants. Because of a class action, the number of claimants will swell to 440,000 by 1995.
Even though many studies showed breast implants didn’t cause autoimmune diseases, juries were upset with Dow Corning for not properly disclosing other risks to women and from withholding safety data. The company would file for bankruptcy protection in 1998. The company set aside a claims fund that would pay anyone who want to cash-out immediately $2,000. Those that wanted their implants removed could receive an additional $5,000 for implant removal surgery and $20,000 for a ruptured implant. Those that had already filed a disease claim were eligible to collect between $10,000 and $250,000.
In 1994 most of the cases resolved. The medical evidence supported the breast implant manufacturers, at least as to claims involving systemic long term diseases such as cancer or lupus. That didn’t mean that the breast implants weren’t responsible for a whole host of other medical problems.
Ultimately that year the major manufacturers of breast implants paid out billions of dollars.
- $325,000,000 paid by 3M Corporation,
- $555,000,000 paid by Baxter Healthcare,
- $1,154,000,000 paid by Bristol-Myers Squibb, and
- $2,018,000,000 paid by Dow Corning.
Breast Implant Lawsuits Today
Obviously, patients can still sue if their breast implants leak, rupture or cause an infection. Although implants are better made today, complications still occur. The companies making these products are responsible for the injuries they cause.
The newer concern is the link between anaplastic large cell lymphoma (ALCL) and breast implants. It took years of scientific study and medical device reports to finally get the FDA to report a link between the two.
In March 2018, one of the first BIA – ALCL lawsuits was filed against breast implant maker Allergan. The plaintiff in that case claims she had Allergan Natrelle Silicone implants for less than two years before developing cancer.
In April of 2018, a woman from Ohio filed a similar breast implant cancer lawsuit against Mentor Worldwide for cancer she believes was caused by her MemoryGel® SIL TEX® Round Moderate Gel Breast Implants. (Mentor Worldwide is believed to have sold breast implants to over 5 million women.)
Mentor is owned by Johnson & Johnson, a company with a long history of selling questionable products.
The women in both lawsuits have had to undergo surgery and chemotherapy.
Are you diagnosed with anaplastic large cell lymphoma (ALCL) and have breast implants?
Whether saline or silicone filled implants, there is a definite link between anaplastic large cell lymphoma. Even if your implant surgery occurred years ago, you may have a case if you are diagnosed with complications, cancer or suffered a rupture. We urge you to speak with a breast implant cancer lawyer immediately.
If you have been diagnosed with BIA-ALCL, it is highly likely that your implants caused your cancer. Once diagnosed, the time to file a lawsuit is limited. We urge you to contact us immediately.
Simply by contacting us, there is never any obligation and it costs you nothing up to get a confidential analysis of your case. We and our nationwide partners accept these cases on a contingent fee basis meaning we only get paid if you win.
If you, a family member or a loved one has suffered complications from breast implants or has been diagnosed with BIA – ALCL or some other cancer as a result of breast implants, please contact us for a no obligation case evaluation. We also invite you to bookmark and visit this page often. We frequently update all of our pages as new information becomes available. Our philosophy is simple, a well-informed client is our best client.
Contact attorney Brian Mahany online or by email at . All inquiries held in the strictest of confidence. We also invite you to visit our dangerous products page for general information about medical devices and products liability.
In addition to the links in this post, please also see:
Breast Implant Associated Anaplastic Large Cell Lymphoma (Journal of American Medical Association)
*Special Note Medical Device Company Whistleblowers
Mahany Law is truly unique in that we often prosecute our cases from the inside out. As a leading national whistleblower law firm, we are always looking to speak with people working within the medical device industry.
Seeking whistleblowers from Allergan, Mentor World Wide, Johnson & Johnson, Sientra and Ideal Implant Incorporated.
Many product device cases come to light when a concerned employee blows the whistle on misconduct within the organization. There are companies such as Johnson & Johnson that have a history of withholding information from regulators and patients.
The elephant in the room is payment for whistleblowers. When Medicare or Medicaid money is on the line, we can seek a whistleblower reward from the government. Our clients have recovered over $100,000,000.00 in rewards to date. Taxpayer funded health insurance doesn’t pay for breast implants, however. That means there are no whistleblower rewards.
As a law firm, we can’t pay whistleblowers either – it is illegal. [In some cases, and only with court permission, we pay a small consulting fee.]
Thankfully, most whistleblowers step forward because they want to do the right thing. They take their profession seriously and don’t want to see patients suffer or get hurt. If you fall into that category, we would love to speak with you. Even if anonymously.
Our goal is protecting patients and get justice for cancer patients. How can you help?
We hope to speak with present or former workers from breast implant manufacturers or distributors with knowledge of reports of leakage, rupture, harmful health complications or cancer.
Have documents? We are interested in those as well. Even if you don’t have the actual documents, tell us where to look. Any assistance is appreciated.
Cancer patient, breast implant patient with complications or whistleblower, we want to hear from you. Please contact us online or by email at . All inquiries held in the strictest of confidence. We also invite you to visit our dangerous products page for general information about medical devices and products liability.