A Litigation Review by Mass Tort Nexus
July 30, 2019
(Mass Tort Nexus Media) The Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.
To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.
What is the connection between textured breast implants and cancer?
Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.
While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.
Breast Implants Can Cause Cancer
There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”
There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.
When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.
The primary makers of breast implants approved for use in the United States include:
Ideal Implant, Inc.
Mentor World Wide, LLC (Johnson & Johnson)
As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.
The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.
Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)
These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA. We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.
|ALCL Deaths from MDRs and Literature reported as MDRs*||Deaths through 7/6/29 (n=33)|
|Age at time of diagnosis (years)||Median||52|
|Not specified (# of reports)||13||39|
|Time from the last implant to diagnosis (years)||Median||9|
|Not specified (# of reports)||23||70|
|Smooth* history of textured||1||3|
|Reason for Implant||Reconstruction||5||15|
|Clinical presentation (breast)b||Seroma||6||18|
|Anaplastic lymphoma kinase (ALK)||Positive||0||0|
|Reporter country: US or OUSd||US||12||36|
a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma
Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)
These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs. We excluded apparent duplicates. The data is stratified by factors we considered in our analysis.
|Unique ALCL cases1||Cases through 9/30/18
|Cases through 7/6/19
|Age at time of diagnosis (years)||Median||53||–||53||–|
|Not specified (# of reports)||111||24||161||28|
|Time from the last implant to diagnosis (years)||Median||9||–||8||–|
|Not specified (# of reports)||110||24||169||29|
|Reason for implant||Reconstruction||108||24||115||20|
|Clinical presentation (breast)d||Seroma||266||58||302||53|
|Anaplastic lymphoma kinase (ALK)||Positive||0||0||0||0|
|Implant manufacturer||Allergan* includes McGhan, Inamed||386||84||481||84|
|Reporter country: US or OUSg||US||276||48||320||56|
1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.
History of Adverse Events Has Been Known
The FDA has coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.
According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.
The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.
Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA. After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.
The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.
In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.
In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.
The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.
Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.
Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.
The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,
Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.
The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.
Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being anywhere between 5 to 10 million around the world.
Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.
There is a growing body of evidence, now supported by thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause debilitating autoimmune disorders as well as emerging evidence of links to certain types of cancer.
No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.
Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.
In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.
Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.
Current Breast Implant Lawsuits:
- Weber v. Allergan (2012)
- Ebrahimi v. Mentor (2016)
- Mize v. Mentor | Nguyen v. Mentor (Spouse Plaintiff) (2017)
- Gravitt v. Mentor | Gravitt v. Mentor (Spouse Plaintiff) (2017)
- Skelton v. Allergan – BIA-ALCL (2018)
- Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
- Rea v. Allergan – BIA-ALCL (2018)
- Vieira et al v. Mentor Worldwide, LLC et al (2018)
- Sewell et al v. Mentor (2018)
- Laux v. Mentor (2015)
- Allergan Saline Lawsuits (2016)
Mentor Silicone Breast Implant Lawsuits:
Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants
(September 28, 2016)
A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.
Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.
Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:
It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.
This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.
Rexina Mize, et al. v. Mentor Worldwide LLC
(February 2nd, 2017)
The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.
Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.
From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:
Catherine Gravitt, et al. v. Mentor Worldwide LLC
(July 25th, 2017)
The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.“
In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”
Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson
(April 27th, 2018)
The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.
They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.
Vieira et al v. Mentor Worldwide, LLC et al
(June 27th, 2018)
Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.
In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.
Allergan Silicone Breast Implant Lawsuits:
Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)
The case was filed in 2012 and is moving to trial in early 2018.
“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)
Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).
“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.
Vivian Skelton v. Allergan – BIA-ALCL
The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.
Rhea v. Allergan – BIA-ALCL
(May 8th, 2018)
Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.
From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:
Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.
Allergan Saline Lawsuits:
In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.
“I represent about 150 women,” said Attorney Chris Shakib.
Shakib, the lead attorney in the case, called his findings unbelievable.
Mentor Saline Lawsuits:
Anita Laux v. Mentor Worldwide LLC
(December 29, 2015)
The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).
Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.
Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.
“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18
Medical Device Reports (FDA)
Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.
As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:
- 87% (203 out of the 231 report) were with textured surfaces
- 12% (28 out of the 231 reports) were with smooth surfaces
Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.
Sample of the FDA Adverse Event Reports on BIA-ALCL:
Note: Parentheses represent redacted information to protect privacy.
- Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
- Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
- Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
- Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
- On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
- The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
- It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.
Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.
BIA-ALCL Causation Theories:
The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.
Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.
Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.
The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.
It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2
In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
BIA-ALCL and Mammograms:
There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.
- Facebook support group: ALCL in Women with Breast Implants BIA-ALCL and their advocacy website, BIAALCL.com
- Facebook support group: BIA-ALCL Clinician/Patient Discussion Group
- Dr. Mark Clemens YouTube: “Patient Education BIA-ALCL“
- Dr. Mark Clemens & American Society of Plastic Surgeons (ASPS): BIA-ALCL
- An excellent article on BIA-ALCL is “Rare cancer reignites debate over breast implants’ safety.”
Government Health Agencies and Other Sources
- FDA: BIA-ALCL
- FDA: BIA-ALCL Q&A
- Canadian Society of Plastic Surgery on ALCL
- Australia: TGA on Breast Implants and Anaplastic Large Cell Lymphoma
- UK: MHRA on Breast Implants and Anaplastic Large Cell Lymphoma
Science and Medical:
Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).
Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.
What You Need to Know About Breast Implants (National Center For Health Research)
Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)
Dr. Myhill –
Dr. Urzola –
“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)
Dr. Feng –
Breast Implant Removal: Basics I
Breast Implant Removal: Basics II
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Note: (Excerpts within this article include other online media sources)
Additional Resources On Breast Implant Complications and Adverse Events
Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.
Breast Implant Removal: Basics III
Breast Implant Removal IV: Detoxification
Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.
MTHFR and breast implants (Video)
Dr. Chun –
“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page
YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).
Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.
Dr. Kolb –
If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.
Book: The Naked Truth About Breast Implants: From Harm to Healing
Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.
Dr. Blais –
All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.
Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.
Dr. Brawer –
Doctors Speak Out –
Dr. Frank Vasey (the “Dark” side of silicone breast implants)
Dr. Stephen Edelson (goes into symptom mechanisms)
Dr. Britta Ostermeyer (on dangers of silicone implants)
Other Educational Videos –
Breast Implant Illness – Dr. Faria
Integrative en-block treatment – Dr. Hovsepian
Capsular contracture – ruptured breast implants – Dr. Cassileth
Immune Response to Silicone (skip to 5:38 for the effects on children)
National Birth Defect Registry
- Did you have breast implants while pregnant?
- Did you breastfeed with breast implants?
- Was your child born with a birth defect? Was your child born with a birth defect?
The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.
***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).
PIP Implants Survey – if you have or had PIP, please fill out this survey
Facebook Support Groups:
For all medical devices: Medical Device Problems
Mothers: Breast Implants and Children
There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.
Personal Stories and Videos:
Alex Chafen – Breast Implants, a Husband’s Perspective
Beth Maturevich – Breast Implant Illness (Saline) Video
Raylene Hollrah – Diagnosed with ALCL, story
Implant Illness Awareness – Breast implants are not safe. We are the proof.
Jamee Cook –
- FB: Breast Implant Victim Advocacy (BIVA)
- FB: Medical Device Problems
- FB: The Implant Truth Survivors Committee (Non-Profit)
- Breast Implant Info (Non-Profit)
- No Grit No Pearls.org (Non-Profit)
- BIA-ALCL Awareness – Just Call Me Ray Foundation (Non-Profit)
- Breast Implant Petition
- FB: Breast Implant Illness – (Australia & New Zealand) Healing and Support
- FB: PIP Implant Rupture Support & Awareness Australia
- PIP Implants Scotland Campaign
- FB: PIP Implants Scotland
- FB: Breast implant illness and explant support group Scotland
Ireland FB Group: PIP Ireland
- Prothese Mammaire Danger
- FB: Dans l’enfer des protheses mammaires
- PIP et Allergan
- FB: Association-PPP
- Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”
- FB: Breast Implant Illness Sverige
Switzerland: Informationen zu Brustimplantaten
Venezuela FB Group: Protesis Mamarias PIP
Singapore FB Page: Implant Illness and Detox Singapore
South Africa: Breast Implant Illness – South Africa
Breast Implant Illness Websites:
BIA-ALCL Awareness – Just Call Me Ray Foundation (Non-Profit)
Breast Implant Info (Non-Profit)
No Grit No Pearls.org (Non-Profit)
Toxic Discovery (Non-Profit)
Breast implant illness websites and forums have been around since the late 90s and early 2000s:
In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.
Breast Implant Manufacturer FDA Information:
For more information on breast implant FDA links and how to do more FDA research, click here.
The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb
The D.I.R.T. Committee by Gail Hamilton
- Must read, especially if you had Dow
- D.I.R.T = Document Investigation & Review Team
The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet
Informed Consent by John A. Byrne
Dr. Andrew Hall Cutler:
- Hair Test Interpretation: Finding Hidden Toxicities
- FB: Andy Cutler Chelation Think Tank
Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.
Press Articles & News:
The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.
Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen
Breast implant illness conference – Texas (7/16/16)
News Segment on a lady with breast implant illness & saline implants
Monsters Inside of Me – Discovery Channel on saline implants with mold
Mold and Breast Implant Illness – The Doctors (TV show)
2017 – Important Year for Breast Implant News –
Breast implant illness gains nationwide coverage and becomes a movement:
‘I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)