Leaking Breast Implant Results in Lawsuit Against Johnson & Johnson

A product liability lawsuit filed last week claims that breast implants sold by Johnson & Johnson’s Mentor subsidiary are defective and prone to leaks. 

The complaint was filed by Rexine Mize on February 2, in the California Superior Court for Los Angeles, indicating that leaking breast implants caused severe muscle pain, nausea and other health problems.

According to report by Bloomberg News, Mize alleges that the problems could have been predicted if the manufacturers had conducted studies that were mandated by the federal government. However, they failed to do so.

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Some observers say that the breast implant lawsuit filed by Mize may be one of the first out of potentially hundreds or thousands of cases that may be filed in the coming months and years.

A similar case was filed against Johnson & Johnson and Mentor by Sara Ebrahimi in September, who said her Mentor MemoryGel breast implants caused her to suffer metal blood poisoning, fatigue and skin rashes.

Researchers have struggled to determine the health risks linked to breast implants. In November 2015, a study in the Annals of Internal Medicine found an association between silicone breast implants and an increased risk of lung cancer.

However, the same study also linked breast implants to a decreased risk of breast cancer and endometrial cancers.

In 2012, UK health officials said the silicone gel in Poly Implant Porthese (PIP) breast implants was not toxic to women. The report revealed the implants had a tendency to rupture in on-third of women, but the industrial-grade silicone gel was nontoxic.

In 2011, the consumer watchdog group Public Citizen warned that the FDA did not adequately alert women to silicone breast implant risks. The group advised women against getting the silicon implants.

Silicone Breast Implant Recall

Silicone breast implants were introduced in the 1960s, and were removed from the market after safety concerns were raised with the FDA in 1992, amid reports of breast implant ruptures. A moratorium was placed on the silicon implants until findings concerning their long-term safety could be determined.

The implants were reintroduced to the market in 2006, after no definitive links to health side effects or disease were found. The FDA ruled against a second silicone breast implant recall in 2011, and called for improved surveillance, demanding manufacturers perform long term follow-up studies.

Federal health regulators have been collaborating with the American Society of Plastic Surgeons to create a national registry, but that registry still has not been finalized. As a result, there is no way of effectively tracking silicon breast implant problems.

So far, known and well-documented silicone breast implant risks include, breast pain, formation of hard lumps under the skin, and capsular contracture, or a hardening of the breast tissue around the implant.

3 Comments

  • Mary G.October 9, 2017 at 4:30 am

    I had breast augmentation done in 2009 with Mentor smooth round silicone but has to have it removed 9 months later due to capsular contractor. My breast was so hard and it was pressing on my chest that I had difficulty sleeping at night. So in 2010 it was removed and put back in but I never got better if anything else I got sick. I was having lower and upper back pain. Headeach that never goes aw[Show More]I had breast augmentation done in 2009 with Mentor smooth round silicone but has to have it removed 9 months later due to capsular contractor. My breast was so hard and it was pressing on my chest that I had difficulty sleeping at night. So in 2010 it was removed and put back in but I never got better if anything else I got sick. I was having lower and upper back pain. Headeach that never goes away. Brain fog, vertigo, suffered from severe capsolar contractor and lots lots more. I was getting so sick that I was having problem concentrating at work because of the pain I'm having. I went to my OBGYN and told my Doctor that I have a lump in my left breast. He requested for me to get an MRI which I did. MRI showed that my left implant was ruptured and they said that my lump on my left breast is benign but have to keep on eye on it. Finally I couldn't take it anymore I know for sure that this implant would kill me somehow if I don't get it out of me soon. So on Sept. 18, 2017 I had the implant removed along with the scar tissue. My PS had to scrape the scar tissue off my ribcage and I had to endure the pain of the of Explant.

  • JenniferFebruary 26, 2017 at 3:11 am

    Thank you for your consideration. Beatrice, I am so very sorry to hear that you are suffering. I too am dealing with a multitude of illnesses due to implants. I reached out to Mentor 7th times about issues that I've been dealing with with no response back from them. I received my first set of implants in 2005. They were smooth, round, and saline, 270 on one side and 300 on the other. I had them fo[Show More]Thank you for your consideration. Beatrice, I am so very sorry to hear that you are suffering. I too am dealing with a multitude of illnesses due to implants. I reached out to Mentor 7th times about issues that I've been dealing with with no response back from them. I received my first set of implants in 2005. They were smooth, round, and saline, 270 on one side and 300 on the other. I had them for about 9 years before I started to develop symptoms. I starting having serious difficulty breathing at all times, and especially when laying down at night. I could not get a deep breath. My PCP checked all labs and my heart and lungs and everything was normal. This was something physical. I also developed tingling and pain in my hands and itchy palms and a numb right thumb. I had a foggy brain and extreme fatigue and difficulty concentrating and depression. Finally, I developed a goiter, an adrenal problem which is a documented adverse reaction to implants. I had the implants removed at the end of 2015. Immediately, my breathing was cured! I no longer had shortness of breath. I know it was the implants pushing on my chest, due to the capsular contraction. They were hard as a rock from the beginning and extremely uncomfortable. The other symptoms were almost completely gone. My breasts were so deformed from the explantation that I decided to have new implants put in to see if it would help the deformity. I decided to try silicone this time because they are suppose to be softer and I figured they would not press on my chest and make it hard to breath and maybe I would not have a bad reaction to them since they are silicone and a more updated FDA approved medical device. Immediately and every day since my surgery 3 weeks ago, I've had ALL of the same symptoms reappeared. I want them removed as soon as possible because I know they are toxic and my body is reacting to them. There should be some kind of warning about the dangers of breast implants. I've read stories and studies about how the outer shell is full of toxins and heavy metals and silicone that leak into the body. I've been reading endless stories online and I know it's what is making me sick, esp since I had them removed for a year then new ones implanted. This has cost me a lot of money, pain and suffering, both mentally and physically, not to mention my now destroyed breasts and self esteem. Even my surgeon said there is nothing that can be done to fix the muscle deformity left after explanting. So I feel ruined for life. This should be a warning as well, that you will NEVER have even slightly normal breasts after removal. It destroys your pectoral muscles so you can never work this muscles again :( I even reached out to J&J and the FDA because Mentor never responded. J&J said they would forward my story to Mentor and the FDA never responded. This all seems so criminal. Thank you for your time and listening. Sincerely, Jenny

  • BEATRICEFebruary 8, 2017 at 10:33 am

    I have been very sick with memory gel Mentor implants. I wrote mentor and the FDA several times. I saw more than 10 specialists because of the immune problems. It ruined my life. I was healthy and ambitious, now I pray for my health to be stable and pain free. Please contact me.

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