Breast implants were a popular cosmetic surgery a few decades ago. Today, they’re not quite as commonplace as purely cosmetic enhancements, but women continue to receive breast implants following mastectomy surgeries.
Breast implants have become safer over time, but there are some long-term impacts from the early implants that continue to cause problems for women all around the country.
In fact, breast implant lawsuits against manufacturers for defective products continue in the courts today.
A brief history of breast implants
Believe it or not, women have been getting breast implants for more than 50 years.
A breast implant is a pocket of liquid placed inside the breast in order to increase its size or change its appearance. As early as the 1940s, women in Japan were getting implants by injecting goats’ milk, paraffin, and eventually silicone directly into their breasts.
In 1962, the silicone breast implant was created and the procedure was first performed on a woman in Texas. In 1976, the U.S. Food and Drug Administration began to regulate implants, which meant they had to meet certain controls and standards.
However, there were adverse events being reported, and that led to the FDA classifying them as a “class III” medical device in 1982. A class III device requires general controls and premarket approval.
The first plaintiff to win a breast implant lawsuit was Mariann Hopkins, who was awarded $7.3 million in 1991 against implant manufacturer Dow Corning. Within weeks of the verdict, the FDA called for a voluntary moratorium on silicone gel breast plants until their safety could be reevaluated. Shortly after, Dow Corning, Bristol-Myers Squibb, Bioplasty and other manufacturers withdrew their products from the silicone implant market.
By early 1992, the FDA had advised that silicone breast implants should only be used for surgical reconstruction or correction of congenital deformities. More than a decade later, the FDA lifted the restriction and now clears silicone implant use for cosmetic purposes for women more than 22 years old.
Between 2008 and 2015, there were about 200 complaints about breast implants reported by the FDA each year. That was a tiny fraction of the number of women receiving implants, so they were regarded as generally safe.
But in 2017, something changed.
In the early months of 2017, the FDA received more than 4,000 reports. Nearly 8,000 more reports were filed in early 2018.
What happened?
It turns out that there weren’t actually 200 complaints per year. When the FDA changed the manufacturers’ reporting requirements in 2017, the numbers suddenly shot up. There are a lot of reasons for this, including how incidents are reported and what’s required in medical records.
The bottom line is that breast implant lawsuits aren’t going away anytime soon.
What makes silicone breast implants harmful?
Recent studies show that silicone breast implants are linked to certain autoimmune diseases. These include:
- Rheumatoid arthritis
- Scleroderma
- Sjörgen’s syndrome
- Sarcoidosis
While there’s not yet enough evidence to make a conclusive link, there seems to be some relationship between silicone breast implants and these diseases. The World Health Organization and the FDA also indicate that silicone breast implants are associated with a rare cancer called breast implant-associated anaplastic large cell lymphoma (BIA - ALCL).
Nearly 500 women have been diagnosed with BIA - ALCL as of early 2019. Usually, the disease will go away once the implants are removed, but not always. Some of the women have required chemotherapy treatment, and 17 deaths are reported.
Breast implants can also cause:
- Scarring
- Breast pain
- Infections
- Sensory changes
- Leakage or rupture of implant
- Bruising
- Bleeding
- Blood clots
- Skin necrosis
- Asymmetry
- Nipple discharge
- Calcium deposits
Breast implant lawsuits
A product liability lawsuit was filed in 2019 by two women who claim they’ve each had a variety of health problems associated with Mentor MemoryGel silicone implants.
Plaintiff Amber Brooks received her implants in 2016. Shortly after, she began experiencing muscle and joint pain, fatigue, weakness, weight loss, recurring vaginal infections, rashes, lesions, bumps, cognitive difficulty, headaches, loss of sensation, inflammation, and gastrointestinal problems.
Plaintiff Jamie Gale, who received her implants in 2009, reported the same issues. Both plaintiffs in the MemoryGel lawsuit had their implants removed and the side-effects disappeared.
And these women aren’t alone. More and more women are coming forward to report breast implant illnesses.
It’s not just the affected women filing lawsuits. There’s also a recent class action lawsuit against manufacturer Allergan, claiming that the company didn’t disclose that certain types of breast implants could increase cancer risk. This lawsuit, filed on behalf of investors, claims that the company knew of the risks and didn’t warn the public.
The common theme in these and other breast implant lawsuits is that the manufacturers knew that there were significant health effects linked to silicone breast implants, but they failed to warn the medical community or patients. They didn’t conduct the studies required by the FDA, and they actively concealed the information about the risks.
Breast implant lawsuit outcomes
Breast implant lawsuits have a long history. These are just some of the larger outcomes:
| Year | Manufacturer | Award |
|---|---|---|
| 1984 | Dow Corning | $1.5 million (punitive damages) and $211,000 (compensatory damages) |
| 1991 | MEC | $25 million |
| 1993 | Mentor | $24 million to settle 1,000 lawsuits |
| 1994 | 3M | $27.9 million to three women ($15 million in punitive damages, $12 million in compensatory damages) |
| 1995 | Baxter Healthcare, 3M, Bristol-Myers Squibb | $3.4 billion to a group of plaintiffs who each received between $10,000 and $500,000 |
| 1995 | Dow Corning, Dow Chemical | $3.9 million (compensatory damages) and $200,000 (to plaintiff’s husband) |
| 1998 | Dow Corning | $3.2 billion settlement fund created to compensate 170,000 women |
| 1999 | Bristol-Myers Squibb | $10 million |
What to do if you’ve suffered breast implant illness
If you believe you’ve suffered an injury or illness due to a silicone breast implant, you might be able to join a lawsuit or file a new one. Generally, these would fall into a product liability claim based on the manufacturers’ failure to warn consumers of the risks of breast implants.
There are specific personal injury lawyers who specialize in defective product litigation. Medical device injuries are common, and there are currently lawsuits pending for a variety of medical devices — including:
- Metallosis from hip implants
- Hip replacement lawsuits
- Vaginal mesh lawsuits
- Knee replacement lawsuits
If you’ve been injured by a medical device, procedure, or drug, talk to an attorney to learn more about what to do next and explore your legal rights to compensation.
Rebecca King says
I currently have mentor smooth memory get. J had a bilateral mastectomy in 2015, in 2017 I had a lump on my nipple so we biopsied. I got an infection had Iv therapy and replaced same implant. I did do a textured saline expander for about 2 1/2 mo before mentor was placed. Since 2015 I have 21 diagnosed conditions. More than 1/2 are s as autoimmune including brain. I explant in Jan 2020 on full disability. Lost 50lbs trying to save my life on my death raising a 5 and 7 yr old. My marriage and job gone. This is a total disgrace! I was given a consent form to sign however zero studies no follow up and no attention to all my illnesses accumulating still. Thx for this site! Get the word out!!! Get them off market! Unsafe can Kill you!
Ian Pisarcik says
Rebecca,
I’m so sorry this happened to you. Thanks for the comment.
Dr jill says
Yes it is a disgrace. I have been sick years all autoimmune. No doc could figure it out. I finally figured it out myself about a month ago and had all the documented to support my diagnosis. This slow release of admittance was purposely a well executed denial that breast implants are toxic to our immune system. The sad think we will receive no money from anyone who ruined our lives. Beacaue of the statue of limitions rule on lawsuits. It’s only 2 years. Allergan has moved to England and file for backrupty to protect themselves from lawsuit the only women who will receive money. Are the 500 who had textured impants. It was a very small number screw everyone else. Allergan. Documented and had on file all the bad reports on all their impants and they knew also. Can’t even sue him because dr. Have a statue of limitation also
Ian Pisarcik says
Sorry this happened to you. Keep in mind that in most cases, the statute of limitations doesn’t begin to run until you discover the injury (even if the discovery occurs years after the implant procedure). If you’re unsure whether the statute of limitations has run, it may be worth talking to an attorney in your area.
Brooke says
Can we sue the FDA?
Suzanne shepherd says
I had breast implants in 1988 they were great , never a problem until about 2016-2017 went to the doctor for health issues , , that’s when they told me they were both ruptured , my son found a dr. In the built more plaza in Phoenix , AZ I’m on access and they paid to take the old ones taken out and my son paid to have new ones put in , soon as I got home something didn’t look right the right breast was red and hot like a temperature , and the left breast didn’t look right , I waited a few days thinking mayb they just had to settle in or something , I went back to the dr. He looked and said you just need to massage the hell out of both of them and they’ll be ok , so I did , it didn’t help I went back to d.r.he said yes the left one had some extra skin below my breast and the right one looked a little off , he said I can fix them but with that he handed me a price list of what it would cost … the left breast looked just like it did before he did the surgery , it’looks ruptured, they just look awful , I don’t know he did , I feel like he should fix them, he did an awful job , it’s not the implants , it was the doctor , thank you for any support I could get , it’s been a year now and they are really ugly…
Melissa Gold says
Hello, Suzanne. I’m sorry you’ve had this experience. My suggestion is to get a second opinion from another doctor. If the second doctor believes that there might’ve been medical malpractice by the first doctor, you should seek the advice of a medical malpractice attorney in your area. Please feel free to consult the Enjuris law firm directory if you need to find someone near you who can help. Best of luck, and I hope everything works out ok.
Darose says
I got implants in 1978. I was 18. I always had tender breasts but thought the discomforts was normal. I started getting conditions in 1981. Gained a new condition every 3 years. Started getting skin sores in the late 90’s. I had put my faith in my physicians and asked several times if my illnesses could be due to my implants. They told me oh no. Conditions kept piling up until 2009 when I was unable to work and was diagnosed withe fibromyalgia. 2 yrs prior I was diagnosed with hypothyroid and bradyacardia. Then fast heart rates. Eventually had to get a pacemaker in 2016 and had been taking meds for fast heart rates. Left O.C. CA and moved to a small desert community where they found both implants had been ruptured and I had been suffering silicone poisoning. I just don’t understand how doctors can get away with this. My disability ended up in federal court and I lost basically because of all the mis diagnosis. Now I’ve been diagnosed with svt. The local SS office realized that I obviously had this condition at least since 2014.. My skin has scars and they say it will probably be 2 yrs at least before it’s out of my system. Now one seems to want to help. All this could’ve been stopped if they had just done MRIs instead of mamograms. But insurance company’s deny most MRIs due to cost. My whole life has been destroyed. I have cysts growing in my pancreas. My blood pressure and all systems are damaged for good. I don’t think I’ll make it another 20 yrs. Just don’t do it. Don’t do anything cosmetically. I wish I hadn’t let my peers teasing me over no breasts affect me so. I could have had a good life instead of one of sadness and pain. Why do they not hold physians accountable for neglagence in such cases. How can insurance company’s pockets be more important than a life? What’s wrong with this picture. Disgraceful!
Melissa Gold says
Hello, Darose. I’m so sorry for what you’ve been through, but thank you so much for sharing your story. There are instances when physicians and pharmaceutical manufacturers are held accountable, but it can be a lengthy and difficult battle. Again, I’m so sorry but so appreciative that you’re sharing your experience with our Enjuris readers. Be well.
Sharlee Sirene says
Hi,
I am a transgender woman who fought for healthcare coverage and most recently for coverage for “top surgery” for transgender people on our company’s insurance plan. I won that coverage.
I had a surgery in May of this year for breast augmentation. The work was beautiful, but within two weeks I had developed an infection on one side and the doctor felt it needed to be removed. He verbally promised me he would cover ALL expenses in replacing it. Now his office is telling me I might have to pay up to five thousand dollars for the surgery or live one sided. I have not been able to confirm this with my surgeon yet. With the current pandemic shutdown, I don’t have the money or insurance to cover that expense.
My research is showing me that an infection that early is almost certainly a result of contamination during placement of the implant or unsatisfactory closure of the suture seam.
Who is legally liable to cover the cost of my injury and repair? Is a lawsuit based on solid legal ground, here?
Melissa Gold says
Hello, Sharlee. I’m so sorry that you’re dealing with this — and our worries about medical care and finances are certainly heightened during this pandemic. I’m not a doctor, so you probably know more about this from your research than I do. However, an implant surgery certainly shouldn’t have to be removed after 2 weeks under normal circumstances. An infection could be the result of contamination, but I think sometimes it just happens and isn’t anyone’s fault (again, I’m not a doctor).
My suggestion is to see another doctor for a second opinion. Unfortunately, there are a lot of possibilities, here. One is that the infection just happened and is no one’s fault. Another is that there was contamination because of the surgical procedure, and a third is that there was some kind of contamination from the implant, itself. If the infection is the fault of the original surgeon, he should be responsible for correcting any issues that arise as a result. If not, you might need to call your insurance company to see what it will cover for whatever treatment you need in order to correct the condition.
I realize you likely need to move quickly on this (it’s never a good idea to wait on treating an infection). However, I would call a lawyer to see what your rights are and to see if they believe this is medical malpractice. If it is a medical malpractice claim, most personal injury lawyers work on a contingency fee basis, which means you don’t usually have to pay until you receive a settlement or judgment. If you need a lawyer, please feel free to try the Enjuris law firm directory for someone near you. Best wishes… I hope you’re staying healthy and can have this resolved quickly.
Karen Jones says
I had a double mastectomy with reconstruction with Silicone gel cohesive implants (gummie bears). Since getting the implants I have gone downhill with my health. I have had severe itching under my implants, and shingles twice under my implants. I am so weak most days and I am not a lazy person but i have to push myself everyday to get anything done. I now have joint pain and memory problems. I have developed arthritis in my hands and feel terrible all the time. I am scheduled for July 21st 2o2o to have mine removed and to have several p laces biopsied. I have no doubt since getting these implants they are making my whole body sick with trying to reject the foreign bodies as well as the toxins building up in my system. I pray that these manufacturers have to pay for what they are doing to these women. These implants are not safe and they did not do enough research to find out. Please If you decide to get implants make sure your not allergic to them and pay attention to your own body…
Melissa Gold says
Hi, Karen. Thank you for sharing your story with Enjuris readers. I’m so sorry to hear that you’ve had so many complications and I hope you’ll be able to recover swiftly. Take care of yourself, and be well.
Lee says
I had smooth silicone implants by allergen put in my body almost 2 years ago this March. I’ve since had double capsular contracture. Of which one contracture broke on its own leaving me no feeling in my right breast. I also have ripples in both implants. They are both changing in size now, also my left is continuing to harden and causing pain now rather than discomfort. My surgeon knew he was retiring when he booked me for surgery but didn’t tell me. He’s trying to get me to sign a patient release now giving up my medical records and making sure I keep my medical records as well as my history with him confidential, and has offered me a $4,500 cheque to if I sign this paperwork. My lawyer I deal with for family law for my husband suggested I see a malpractice lawyer and told me NOT TO SIGN THOSE PAPERS
Rosana Lopez Calvette says
Me puse implantes Mentor en el 2014, durante estudios realizados el año pasado, los medicos descubren un implante roto.
Los implantes tienen una garantía de por vida y solo han durado 5 años.
Estoy planificando mi cirugía para reemplazarlo, Mentor solo quiere proveerme un implante y obviamnete no pagar la cirugía
Es esto correcto?
Ian Pisarcik says
Lamento que le haya pasado esto.
Si la garantía cubre o no el costo de la cirugía de reemplazo depende completamente del texto que se encuentra en la garantía.
Parece que la garantía estándar de Mentor cubre los implantes de reemplazo. También parece que los pacientes que se han inscrito en el “Plan mejorado” son elegibles para recibir hasta $ 2,400 en asistencia financiera para costos quirúrgicos no cubiertos por el seguro si la ruptura ocurre dentro de los 10 años posteriores a la cirugía.
En teoría, si los implantes están defectuosos, es posible que pueda presentar una demanda contra el fabricante para recuperar el costo de la cirugía. Sin embargo, tenga en cuenta que el hecho de que los implantes no duraran toda la vida no significa que estén defectuosos.
Si desea que un abogado revise su garantía, puede encontrar uno usando nuestro directorio en línea gratuito.
JoPuss says
I had a reconstruction after a right mastectomy and also an implant on the left to balance me up size wise. This was in 2015.
I have been suffering with breast pains, chest and torso pains, breathing problems (I have severe COPD after chemo) and generally feeling dreadful for 9 + months. My doctor sent me for emergency tests after I had had to call and ambulance and Respiritory team as my breathing was so bad. They could find no reason fir the symptoms.. so blood work, X-ray, CT scan and dye and it shows I had enlarged lymph nodes in my right armpit.. with having triple negative stage 3 breast cancer previously I was sent fir an ultrasound.
It showed that thankfully the cancer had not returned but.. but implants have been leaking and I have silicone I’m both army and also my lymph nodes in both armpits too… currently waiting for replant op… it can’t come soon enough, even though due to my respiratory issues I’m scared of the anaesthesia, I just want to feel well again.
Is the implant company liable for these faulty implants?
I’m in the UK 🇬🇧
Kim says
I’m in the UK and I was recently diagnosed with Large cell lymphoma (BIA ALCL) cancer. I was not warned of the dangers of breast implants which I had back i. 2006, 15 years ago. They were the Allergan textured ones. I had a full en bloc capsulectomy and some lymph nodes removed. I was not even informed by the hospital that put them in that there was a risk once they found out about this cancer about ten years ago. Had they informed me then I would have had them removed just in case. But no, instead I end up with cancer because of them. I’m still currently under the hospitals care and will have another full body PET scan in five months to check no more growth anywhere else in my body.. I can’t even sue transform as apparently they went into liquidation then opened up in a new name!!! Disgusting!
Tracey Viera says
I have suffered a great deal for my breast implants I have lymph node problems underneath my armpit for the last 10 years as well as a blood clot near the lymph nodes in my left arm my breast have tripled the size since they were put in I’m in a lot of pain it’s very uncomfortable and my blood clot doesn’t seem to be going away with the medication I’ve been taking for the last year do I have a lawsuit if so please contact me at (XX) sincerely Tracy Viera
Melissa Gold says
Hello, Tracy. I am sorry that you’re dealing with this! I am not a doctor and can’t advise as to the cause of your medical concerns. However, you can revisit the physician who gave you the implants to see if there’s anything they can do to remedy the issues you’re experiencing. If you believe that the doctor committed malpractice (i.e. made a mistake that could be negligence), then you should seek the opinion of a different surgeon. If your doctor’s treatment was negligent, then you could have a malpractice lawsuit. Alternately, if it’s a defect in the implants (not the doctor’s fault), then you might have a case against the manufacturer of the implants. Once you can get some concrete medical opinions as to the cause of your issues, then you can visit the Enjuris law firm directory (https://www.enjuris.com/personal-injury-law-firms/) and seek the advice of a lawyer in your state who can guide you through the legal process if necessary.
Best wishes, and I hope your medical issues are able to be resolved. Take care.