Scroll down for a current list of breast implant lawsuits. Mentor 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. If you are interested in following developments in any of these cases and in our information in regard to breast implant lawsuits please leave a comment below.
Where to Start:
Gather all medical records from each of your medical providers, such as: implanting surgeon, primary doctor, specialists, dentist, etc. Regardless of a lawsuit, it is important to keep your own file of all pertaining medical records. How long medical offices are required to retain medical records varies with each state. See requesting medical records for more information.
1. Obtain every page of your plastic surgery records (all operative reports, follow-up visits, etc). Ask if you were part of a manufacturer breast implant study and check all your records for any notes made by the surgeon.
2. Write down all your symptoms and try to put them in chronological order. Note the year and the month if possible of when each one started. This is important to document.
3. Talk with your doctor; share the chronology of symptoms and provide scientific literature of foreign body reaction and silicone as an adjuvant. Explant is a medical necessity procedure for many of us. Discuss this with your health care provider and see if a Medical Necessity Letter can be written.
4. Do heavy metal and chemical testing before explant to see if there is any measurable, quantitative toxicity, as well as any other lab work that is related to your health. There is a toxicology lab in Colorado called The Carlson Company that can do heavy metal and chemical testing of explanted capsule tissues.
5. When you explant make sure your implants and capsules are not destroyed and make arrangements to secure them. Ask your surgeon for pictures of the implants and capsules at the time of surgery. You can even try asking if they will video the surgery. Maintain a chain of custody for both, implants and capsules.
6. Research medical device product liability and parallel state law claims. There have been an increasing number of Class III medical device parallel claims pursued with relative success.
7. Research and put together a list of other medical device cases that have either won or are currently ongoing against your manufacturer or other medical device manufacturers (ex. transvaginal mesh, hip implants, Essure cases, etc).
8. Search for a product liability lawyer. Provide them with your research in an organized fashion: a chronology of your medical history, any doctor reports that support your allegations, the current breast implant cases below and the other current medical device cases you researched.
9. When researching and choosing a law firm, ask what their intentions are in the larger scheme – are individual cases being filed for the purpose of a MDL (multi district litigation) or is a collective class action being organized? Pay caution if a law firm is preparing for a breast implant class action lawsuit, those are what happened in the 90s and were ultimately in the best interest for the attorneys, not the women. Class actions in this type of litigation result in low ball settlements and high attorney fees.
10. Read over a retainer very carefully, make any adjustments, and sign with the law firm. Generally, product liability and personal injury cases are taken on contingency. This means the attorney shall advance litigation costs, travel expenses, copying fees, expert witnesses, etc. In a contingency case you should not have to upfront costs. If you win the case, a lawyer’s fees come out of the money awarded. Contingency fees can range from 25-40%, with average being 33% or one-third. If there is trial involved, contingency fees can be 40%.
In the 1990s, Dow’s scandal of falsified studies, circus of inadequacy in faulty manufacturing, and campaign of deceit and denial was exposed. Over 450,000 women came forward, litigation and bankruptcies ensued among various breast implant manufacturers, along with a moratorium that banned silicone breast implants for 14 years, from 1992-2006. The exception for their usage were certain reconstruction and revision cases that were supposed to be enrolled and followed in manufacturer ‘Adjunct Studies.’ The book ‘The Document Investigation and Review Committee (D.I.R.T.)‘ by Gail Hamilton provides excellent insight on the matter.
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)
- 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.
Ms. Ebrahimi is represented by the law firm of Cotchett, Pitre & McCarthy, LLP, which has decades of experience litigating complex cases involving defective products that harm consumers. They are currently not accepting any new clients for breast implant cases until they can get passed preemption.
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:
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” Moss said. “This suit may be just the tip of the iceberg.”
“The suit filed yesterday contends Mentor officials failed to warn Mize, who says she’s suffering from pain, nausea, skin rashes and extreme fatigue, and her physician about “the risk of serious defects and life-altering complications” tied to the leaking 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.
They are represented by Lenze Lawyers, PLC in Manhattan Beach, California; Finson Law Firm, LLP in Playa Vista and Marina Del Rey, California; and by Angwin Law Firm in Los Angeles, California.
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.
They are represented by Ross Feller Casey, LLP in Philadelphia, Pennsylvania.
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).
Medical Device Safety Act H.R. 2164
Please take a short moment to sign and support the Medical Device Safety Act H.R. 2164, a bill introduced to restore an injured consumer’s rights to sue Class III medical devices that are currently being preempted by federal protection.
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.
“What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.
The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.”
The Medical Device Safety Act H.R. 2164 would create an amendment that would allow product liability state laws to not be barred by federal supremacy. Therefore it would allow an avenue to get justice again and hold the manufacturers accountable to the harm they have caused.
Disclaimer: The materials available at this web site are for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.