Concerns over Breast Implant Illness Prompt FDA Investigation

breast implant illness

The U.S. Food and Drug Administration (FDA) is reacting to reports from a grassroots movement comprised of real life patients who claim they developed breast implant illness.  After being dismissed by the medical community, the women turned to Facebook and other social media platforms to spark attention and action.

Breast implant illness is an issue silently affecting thousands of women.  Without satisfactory response from the medical community or medical device manufacturers, these women demanded regulatory action from the FDA, and it looks like they are going to get it.

The FDA scheduled a two-day conference to investigate the safety of breast implants, breast implant illness, and a rare cancer associated with breast implant recipients.  This is not a recall of any particular product, but rather an exploratory effort to determine whether such a step should take place.  At present, the prevailing opinion in the medical community is that breast implants are safe.

What is Breast Implant Illness?

Breast implant illness is a broad term for the experience that thousands of women have had following breast implant surgery.  They complain of symptoms indicating immune system disease, such as:

  • Muscle pain
  • Fatigue
  • Weakness
  • Cognitive difficulties
  • Memory lapses
  • Migraines
  • Numbness of the hands
  • Sjogren’s syndrome

Breast implant illness also refers to connective tissue diseases that may be caused by implants such as:

  • Lupus
  • Rheumatoid arthritis
  • Scleroderma

According to various breast implant illness studies, women with breast implants have:

  • 22 percent higher risk of developing autoimmune or rheumatic illnesses than the general population.
  • Up to eight times higher rates of Sjogren’s syndrome and scleroderma (an autoimmune disorder and a connective tissue disorder, respectively), both of which are fairly rare.

If you have breast implants and notice any symptoms listed above, or others that may be related to these disorders, seek immediate medical attention right away.  If your illness is linked to your implants, you may also find it helpful to consult with a breast implant illness attorney to learn more about your rights.

Cancer Associated with Breast Implants

Of the most troubling concern is a rare cancer called anaplastic large cell lymphoma.  The FDA has identified nearly 500 women diagnosed with this cancer who also have breast implants.  Treatment involves removing the implants, which is largely successful.  Most women experience a full recovery after implant removal, though some have needed chemotherapy.  More than a dozen women with this cancer have died.

Anaplastic large cell lymphoma has been most commonly diagnosed in women with textured implants, which are rare in the U.S., but are still used.  The link between breast implants and this type of lymphoma have not been extensively researched.

Other Risks of Breast Implants

The FDA has published numerous warnings on the subject of breast implants including a comprehensive summary of their concerns.  In addition to breast implant illness and cancer, patients with implants risk:

  • Capsular contracture (scar tissue that forms around and squeezes the implant)
  • Breast pain
  • Changes in sensation
  • Deflation of saline implants
  • Rupture of silicone implants
  • Silent (asymptomatic) rupture of silicone gel implants
  • Skin damage or breakdown
  • Chest wall deformity

Breast implants are not medical devices meant to last a lifetime, so their care and maintenance requires reoperation and all the risks that normally accompany surgery, such as infection and anesthesia injuries.  Complications like these can lead to a lifetime of pain and deformity.

Are Breast Implants Dangerous?

The short answer is, right now, no one can say for sure.

The medical community is hotly debating the issue of implant safety amid the new concerns.  Some physicians warn the public about the high instances of rare disease among implant recipients, and some doctors insist that implants are safe.  It is interesting to note at least one of the latter doctors quoted by the New York Times is a consultant for a major silicone implant manufacturer.

Immune system disease and connective tissue disorders are relatively uncommon among the population at large, but multiple studies indicate a startlingly high number of these problems in breast implant recipients.  The FDA is expected to issue more authoritative findings on these chronic symptoms after their conference this week.

Regardless, many of the studies that have taken place to date have been studying a particular disorder and have ignored breast implant illness sufferers’ generalized complaints of chronic tiredness or joint pain.  Most of the studies to date have been funded by plastic surgery associations or the implant manufacturers themselves, who clearly have a vested interest in the findings of such studies.

Recent Actions by the FDA

Though the FDA says it is not ready to draw a connection between breast implants and the illnesses suggested to be caused by them by the recent studies, it has recently reprimanded two different manufacturers for failing to comply with expected data-tracking procedures.

In public two public letters, the FDA admonished manufacturers Sientra and Mentor Worldwide (owned by Johnson & Johnson) for failing to collect health and safety data on a large enough sample size of breast implant recipients.  Without the data it has requested, the FDA has said it cannot rule out the recent allegations of breast implant illness.

As mentioned above, the FDA has also convened a two-day advisory conference on this subject.

Past Recalls Due to Breast Implant Illness

Breast implants have been in use since the 1960s, and the FDA has been keeping track of consumer experiences with these devices since that time.  As with any new technology, there have been some adjustments throughout the decades.

Breast implants are either smooth or textured silicone sacs filled with either silicone gel or salt water (saline).  Saline-filled implants are considered somewhat safer than silicone-filled implants because of their decreased risk of complications from rupture.  The FDA banned the use of silicone breast implants in 1992 due to the risk of rupture that caused overwhelming complications and death.  Many women sought legal remedy in the 90’s due to the suffering caused by their silicone implants.  Silicone gel-filled implants were reintroduced to American markets in 2006.

More recently, implants with textured outer sacs have come under scrutiny.  Almost all the lymphoma cases associated with breast implants were diagnosed in women who had received the textured implants.  Textured implants made by manufacturer Allergan were recalled in Europe.  Textured implants are still in use in the U.S., but not so often as smooth implants.

Who Should be Concerned About Breast Implant Illness?

Anyone who has had breast implants for any reason, and for any length of time, has cause for concern.  That includes the more than 10 million women worldwide who currently have breast implants.  In the U.S.:

  • 400,000 American women get breast implants each year
  • 300,000 of these are for cosmetic reasons
  • 100,000 are for reconstructive reasons

Breast implant illness can affect any of these millions of women.  It is currently affecting the many whose suffering prompted the call for the FDA conference going on this week.

Women who have silicone implants from a surgery that took place during or prior to 1992 have particular reason to be concerned.  Not only are silicone implants from that era determined by the FDA to be dangerous, but also breast implants become increasingly inclined to rupture the longer they are in the body.

Even women with relatively recent surgery have reason to be concerned about breast implant illness.  Symptoms of breast implant illness can develop at any time – either shortly after surgery or years later.  Doctors do not understand why some women develop symptoms at drastically different times than others.

Consult with a Breast Implant Illness Attorney

While the debate rages in the medical community, the fact is that women are suffering.  The issue of liability for harm from breast implants or breast implant illness promises to be a complicated one that will need the attention of lawyers very familiar with dangerous medical devices.  If you or a loved one has concerns about breast implant illness, contact Drug and Device Watch  to learn more.