MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS: What’s Next?

MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS AND CANCER: IS THIS AN EMERGING MASS TORT? 

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

By Mark A. York (May 8, 2019)

 

 

 

 

 

 

 

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

In addition to the warning notice to Mentor Worldwide in March 2018 (above), the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. The FDA shas  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.

In the U.S. and Canada, regulators did not impose any consequences after manufacturers lost track of most of the participants in a large-population health study within three years, although a 10-year study was ordered as a condition of allowing silicone implants back on the market.

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.

Typical Breast Implants Placement

Silicone Breast Implant History

History that breast implants have caused serious health problems, but for most of the public, that problem is assumed to be a historical reference, because those implants were removed from the market, so the current implants on the market must be very safe.

While the FDA now openly mentions problems that often occur in many women with breast implants, such as leaking and rupturing, they fail to warn the public about the more dangerous connection to auto-immune disorders.

The FDA actually allowed implants to be put onto the market for over 40 years without formally approving them, so it’s not a best practice to trust what the FDA says.

The lawsuits in the 1990’s involved 450,000 US women who sued  Dow Corning, one of the world’s largest manufacturers of silicone implants.

While Dow Corning never admitted that their implants were dangerous, they paid out enormous amounts to the victims. Their implants of the 1970’s had a very thin outer shell, and had a high leakage rate. Many women even lost their lives from illness caused by these implants, while waiting for a legal resolution of their lawsuits against Dow.

It was disclosed that Dow Corning knew for a very long time that their implants were toxic, yet covered it up for as long as they could.

In their own animal studies, researchers found that silicone could easily leak into the body, and caused tumours in up to 80% of the rats that were being tested on, see Fig. 7. The numbers were so alarming that the FDA, instead of being concerned, called these studies “erroneous,” which basically means they ‘must’ have been incorrect. The FDA then approved the Dow Corning implants, despite protests from some staff members that there were troubling warning signs.

We’ve also heard about the now infamous French PIP implant scandal which hit worldwide news recently. These implants (which were found to contain toxic chemicals used in mattresses and not approved for human use) are now banned, and women in the UK were offered free treatment to have them removed.

Shocking Ingredients Found In Dow Silicone Implants

When women are told that their implants contain silicone or saline, they often don’t tend to ask if anything else is being used alongside it. They certainly aren’t told this by the surgeons, who more than likely don’t even know themselves.

Check out the long list of alarming ingredients used in Dow’s silicone implants which came out during their court case when they were forced to disclose what was in their dangerous implants:

  • Methyl ethyl ketone (neurotoxin)
  • Cyclohexanone (neurotoxin)
  • Isopropyl Alcohol
  • Denatured Alcohol
  • Acetone (used in nail polish remover and is a neurotoxin)
  • Urethane
  • Polyvinyl chloride (neurotoxin)
  • Amine
  • Toulene
  • Dicholormethane (carcinogen)
  • Chloromethane
  • Ethyl acetate (neurotoxin)
  • Silicone
  • Sodium fluoride
  • Lead Based Solder
  • Formaldehyde
  • Talcum powder
  • Oakite (cleaning solvent)
  • Methyl 2- Cynanoacrylates
  • Ethylene Oxide (Carcinogen)
  • Xylene (neurotoxin)
  • Hexon
  • 2-Hedanone
  • Thixon-OSN-2
  • Stearic Acid
  • Zinc Oxide
  • Naptha (rubber solvent)
  • Phenol (neurotoxin)
  • Benzene (carcinogen/neurotoxin)
  • Lacquer thinner
  • Epoxy resin
  • Epoxy hardener
  • Printing Ink
  • Metal cleaning acid
  • colour pigments as release agents
  • heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
  • Platinium
  • Silica * (2)

What’s In Implants Today?

The current problem is we just don’t know. Its very difficult to find out exactly what is in current implants today. There nothing that shows a full ingredient list. Plastic surgeons state they have ‘never seen a full list’ and implant websites, do not disclose what is in their products.

Some scientists have been taking an in-depth look at the platinum, a toxic salt, found in silicone implants and its connection to ill health. However, after looking at this list above, it seems ludicrous to suggest that one individual ingredient would be the sole cause of these health problems. It’s clear that breast implants are completely toxic.

Its important to know that saline implants ALL have silicone outer shells, so these too can leak silicone and other ingredients into the body, either through rupturing or when the textured surface flakes off.

Types of Breast Implants Used Today

Silicone Implants

Many women opt out of having silicone implants due to the Dow Corning Lawsuit. But a growing number of women are now choosing to have them again due to the implant’s ability to look more natural than other types. These implants have an elastic type envelope which is pre-filled with a sticky, clear, jelly-like form of silicone. There are a few varieties of shapes to choose from, with smooth or textured surfaces.

With the FDA allowing silicone implants to come back on the market, it is very concerning to know that statistics show (according to Nancy Bruning, author of Breast Implants — Everything You Need To Know) that almost half of all women who have this type of implant will experience a rupture within 6-10 years, and one in five women were found to have silicone migrate to other parts of their bodies.

 

 

 

 

 

 

According to Dr Susan Kolb, world expert on breast implants, silicone implants should be completely avoided.

 

 

 

 

 

Saline implants – silicone outer shell, saline liquid inserted during surgery by surgeon

Saline Implants

Saline implants are commonly thought to be safer, yet they have their own problems. Saline implants have a silicone shell filled with a saline water, which is salt based and ‘sterile.’ Some types are inserted empty which the surgeon will inflate during surgery with this saline liquid. There is another type of saline implant, which also has a silicone shell, but the inside contains a gel like texture. There are smooth surface saline implants and textured surface saline implants.

According to research experts, 60% of women with these types of implants have complications within four years, and one out of five require additional surgery within three years.  This seems to be a cause for concern, since patients are commonly told that implants either never need to be removed or should be removed every ten years.

Possible Side Effects

This is what your surgeon does not tell you:

  • tenderness, lumpiness, or discomfort around the implants
  • change in the shape of your breast(s)
  • change in the consistency of your breast, such as increased softness
  • change in the way your breast moves – all of these symptoms may be a sign your implant has ruptured.
  • hardening of breast tissue
  • muscle pain
  • pain and swelling of the joints
  • pain in the soft tissues
  • a burning sensation of pain
  • tightness, redness, or swelling of the skin
  • swollen glands or lymph nodes
  • unusual, extreme, or unexplained fatigue
  • swelling of the hands and feet
  • unusualhair loss
  • rashes
  • skin thickening or hardening
  • dry eyes, mouth, or vagina
  • loss of memory, mental confusion, or ‘fogginess’
  • autoimmune disorders such as fibromyalgia, rheumatoid arthritis, scleroderma, multiple chemical sensitivity disorder, cancer, and biotoxicity problems.

Above is an excerpt from Breast Implants – All You Need To Know by Nancy Bruning.

 

 

 

 

 

 

 

 

 

 

A ruptured silicone implant. The red is tissue that had to be removed from the patient. The sticky consistency on the right is what comes out when ruptures and leakage occur.

Breast Implants Can Cause Cancer

It might not surprise some of you reading this to learn that there is a link between cancer and implants. 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.

Suicide Risk

Another little known factor about breast implants is that there is a connection between suicide. While this connection might be more about the woman’s mental status prior to having the surgery (perhaps she suffered from low self esteem and thought implants would make her much happier), it could also be because of the stressful impact the implants have on the body and its many important systems. As we have seen above, implants are linked to neurological disorders, amongst other concerns.

Women who have implants are at least 3 (some sources say 4) times more likely to commit suicide than those who do not have them.

The American Society of Plastic Surgeons (ASPS) reported that 329,396 women have undergone breast augmentation in the United States, an increase of 55% between 2000 and 2006, making it the most frequent US surgical cosmetic procedure for 2006 (ASPS, 2007). Although many studies have explored psychological aspects of this type of surgery, the consistently dramatic increase in numbers of breast augmentations, some that result in adverse psychological outcomes, remains a serious concern for health care providers. Surprisingly, very little is known about either the psychological characteristics of cosmetic surgery patients or the psychological impact of the surgical procedures. This literature review focuses on psychological issues in relation to breast augmentation procedures, including recent suicide findings related to this procedure. Conclusion of this review supports the necessity by health care providers to consistently screen patients for psychological disorders, such as Body Dysmorphic Disorder (BDD), prior to conducting cosmetic surgical procedures, specifically breast augmentation. See https://www.ncbi.nlm.nih.gov/pubmed/19499438, Psychological Issues Associated With Breast Augmentation  2009 Jun;30(6):377-82

Mammograms Can Rupture Breast Implants

 

 

 

 

 

 

 

Mammogram on a patient without implants 

If you have implants, you need to be aware that having mammograms can actually do serious damage to them. Because the procedure involves intense squashing down of the breast tissue, this has been known to cause ruptures, and if the implants do begin to leak, what is inside them will likely leak into your body.

It must be said that there is also alarming information that mammograms are not safe to have, even if you don’t have implants.

Is There A Safe Implant?

If you choose to get implants, then according to breast implant expert Dr. Susan Kolb, the safest type is the saline implant that has a smooth surface and does not have a valve. This is because the textured implants have been found to have particles flake off into the person’s body which can then attack the immune system. If there is a valve, as mentioned previously, a systemic fungal infection can ensue.  But even with this type, problems can happen in the future and lead to drastic complications, and it now seems to be leading toward Breast Implant Litigation Round II.

As discussed in the article What You Need To Know About Breast Implants, the authors wrote about the concerns with breastfeeding and toxicity:

According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding. Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue. A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.

THE FAILS AGAIN

The FDA has also posted an unusually blunt warning on its website. It advises patients that the risk of complications is high and says flatly:  “You should assume that you will need to have additional surgeries.”

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.

A Clear Example of What Can Go Wrong

Please check out Susan’s experience that really turned into an utter nightmare for her, which is still affecting her health today. Below is a picture of her implants that she had recently removed.

 

 

 

 

 

 

 

 

 

 

 

 

 

Susan’s implants which were moved back in April this year. The one on the left was so ‘jelly like’ it had to be scraped off her ribs. The right one, although looks quite normal, actually had a small rupture too. The red tissue is what the surgeon also had to remove to ensure all the silicone was gone.

To access information on Breast Implants II and the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Barbara Capasso at 954.530.9892 or Barbara@masstortnexus.com.

  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for free access.

 

Leave a Reply

Your email address will not be published. Required fields are marked *