SILICONE IMPLANTS

Over the last 10 years, breast implants have again soared in popularity, after being banned for 14 years. The FDA effectively banned silicone implants since 1992, but on June 23, 2011 lifted the ban. Hollywood, Las Vegas, plastic surgeons, and the legal industry all are very happy, but will you the consumer be happy?

Over the last 50 years, 2 million women have had silicone breast implants to look better. Today many of your mothers and aunts still suffer the side effects from silicon toxicity and decreased immunity.

Breast implants have a short shelf life, and no matter what material is used,(saline or silicone), they can’t withstand the wear and tear. The implants cause the breasts to harden, wrinkle, and become asymmetrical. The nipples lose their sensation, breasts shift from their original position, and mammography can’t detect cancer. Scar tissue contracts around the implants, squeeze the implants making them more firm resulting in pain, and causes your natural breast tissue to shrink.

No one knows how long your implant will last; eventually all implants break ( averages 7 to 12 years), and must be replaced or removed. Additional surgery is required in 46% of women with silicon implants and require re-operations. Over 25% of silicon patients end up having their implants removed. The National Cancer Institute found a 21% increased risk of cancer in women who have implants for seven years, and women with implants for 12 years were more likely to die from lung and brain tumors.

A LITTLE HISTORY

During World War II, Japanese prostitutes had non-medical grade silicon injected to enlarge their breasts. It was not till the early 1960s, when Texas plastic surgeons, Cronin and Gerow, placed
the first silicon breast implants. In 1976, the FDA received authority to review the effectiveness of new medical devices (the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act). Since implants were on the market already for 15 years, they were grandfathered.

Dow Corning the following year paid $170,000 to a Cleveland woman who claimed her ruptured implants caused numerous operations, pain, and suffering. Ralph Nader, in 1980, sent warning signals that silicone implants cause cancer. This prompted the FDA in 1982, to reclassify the implants as class III. To keep implants on the market. manufacturers were required to prove breast implant were safe. In 1984. (Stern vs Dow Corning, San Francisco), a jury found Maria S. Stern to have acquired systemic autoimmune disease because of her silicone breast implants. She received $1.5 million dollars in punitive damages and $211,000 in compensatory damages. The evidence in this case is still sealed by court order.

In 1988, the FDA demanded premarket approval applications from silicone breast implant manufacturers, requiring them to provide valid scientific data that their implants were safe and effective. The FDA would then evaluate the safety of the implants by reviewing the submitted manufacturer’s data.

In 1990, Congressional hearings were held about the safety of these implants. They concluded much of the information available to the manufacturers was not available for their scrutiny. Dow Corning six months later finally released 329 new studies to the FDA. The next month, July 1991, Baxter settled another autoimmune problem case for $5.4 million. In September, the FDA said the manufactures data did not prove implants were safe. In November, an FDA panel advised the FDA on what to tell the public about the safety and effectiveness of implants based on the manufactures data. The panel rejected Dow Corning’ data and recommended the devices be available to a very limited patients.

The next month, December 1991, Dow Corning paid another 7.3 million to a patient who had mixed connective tissue disease because of ruptured implants. The lawyer, Dan Bolton, after winning the suit, gave the FDA internal memos and studies that the FDA had never seen before. By the end of 1991, 137 individual lawsuits were filed.

In January 1992, because of pressure by the FDA advisory panel, the manufacturers agreed to a moratorium on implantation until the FDA considered new available information. The next month, a class action lawsuit was filed in Cincinnati to compensate women faster. This caused Dow Corning to replace their CEO. The FDA panel met again and recommended the implants to be limited to only reconstruction use until more epidemiological studies could be conducted on the risk of autoimmune diseases. Internal Dow Corning memos were released to the public, and Dow Corning quit the silicone breast implant business, leaving Bristol-Myers, Bioplastic, and Mentor as the only manufacturers. New rules on use of the silicone implants were set by the FDA, with the moratorium lifted. Only patients undergoing breast reconstruction could receive implants, and the patients had to become part of a scientific protocol.

By the end of 1992, over 3500 law suits were filed against Dow Corning, (By the following year, over 12,000 cases were filed). A Houston woman was awarded $25 million and another 20 million for punitive damages, because of autoimmune symptoms, chronic pain, and headaches. The next year, another Houston jury, awarded three women a total of $28 million, plus another $15 million in punitive damages, and another 12 million in compensatory damages for illness.
In March 1994, a class-action suit was finalized with Dow Corning (the biggest contributor_, along with Baxter, Bristol-Myers, and 3M. Over 440,000 women registered for the settlement, and 70,000 received immediate compensation. By December 1995, 15 individual lawsuits went to trial with Dow winning eight, and losing six, with one split decision.

After input from a panel of impartial scientists, Oregon Judge Jones, in December 1996 ruled that lawyers cannot present evidence that implants cause disease, because it is scientifically invalid. In August 1997, a New York State jury found that Dow knowingly deceived women by hiding safety information about the silicon in the implants.

In July 1998, finally, plaintiffs accepted Dow Corning’ offer of $3.2 billion to settle tens of thousands of claims. This allowed Dow Corning to emerge from bankruptcy.
In spring 1999 , silicone-gel-filled implants remained off the market in the U.S. pending manufacturer safety studies. They were available only to women who had breast surgery for a medical condition or had other complications from existing implants, and only if they agreed to be part of a scientific protocol, or study. The latest status of silicone breast implants can be found at the FDA website.

Congress asked the Institute of medicine, a part of the National Academy of Sciences, was asked to set up a committee. They examined past research, conducted hearings, and concluded that “silicone breast implants may be responsible for localized problems as hardening or scarring of breasts tissue, but they do not cause any major diseases as lupus or rheumatoid arthritis.(Sources: The New York Times, Bloomberg Business News, AP, and American Academy of Neurology).

In August 2000, the FDA approved a study by Mentor for its silicone gel filled breast implants. In October 2003, Allergan’s silicone implants were reviewed by the FDA advisory panel, and approved by a 9 to 6 votes with conditions, including a minimum age requirement for augmentation.

In April 2005, implants from both companies were reviewed by the advisory FDA panel. It approved by a 7 to 2 vote Mentor’s implant, but denied Allergan’s implant by a vote of 5 to 4.
The FDA effectively banned silicone implants since 1992, after fears arose of a possible link between the implants and certain autoimmune diseases. Implant use was restricted to mastectomy patients participating in clinical trials. At the time, some in the medical research community criticized the ban, saying the decision was based on public opinion, not science – and that in fact little evidence existed on either side of the debate.

In November (2006), the FDA approved both companies silicone filled implants, lifting the 1992 moratorium. A condition for implant approval was that: The manufacturers conduct six post approval studies to characterize the safety and effectiveness of these implants and answer scientific questions that the pre-market clinical trials could not answer.
In 2006, the FDA, after 14 years of implant banding, again allowed silicone breast implants back on the market claiming that further study showed the decision reasonable. Consumer groups criticized the FDA decision because of widespread fear that implants had caused a wide range of illnesses.
LYMPHOMAS
In January 2011, the FDA issued a safety communication for women with implants with concerns about anaplastic large cell lymphomas that occur in the scar capsule near the implant.
Over 60 lymphomas have been found in women with breast implants. More women with breast implants are now found with other kinds of lymphomas, as Hodgkin, central nervous system lymphomas, and mycosis fungoides.

Since 1960, when breast augmentation was started, between five and 10 million implants have been done. All we know are the numbers sold, but we are not certain how many have them. Many had their breast implants taken out, replaced, and had one or two I breast implants.

Generally Lymphomas are caused by chronic suppression of the immune system and are associated with infections as Heliobacter, Chlamydia, Campylobacte, HIV, hepatitis c, and Epstein-Barr virus.

The FDA wants to know about more than just Hodgkin lymphoma. ( ironically, nothing about lymphomas was said when the FDA announced lifting the ban on breast implants. The FDA hotline number is (1-800-332-4088) for reporting additional cases. You, or your doctor, can go to the FDA Medwatch Website and report cases of breast implants and lymphoma.
Source: Dr. Bruce Cheson, Georgetown Cancer Center,3.18/2011

RECENT FDA DECISION TO LIFT THE BANNING OF IMPLANTS

On, June 23, 2011, the FDA said that further studies have shown their decision was very sound. The FDA reported the initial findings by the devices' manufacturers, Santa Barbara-based Mentor Inc. and Irvine-based Allergen. The companies were required to conduct post-approval studies on more than 80,000 women over 10 years.

The director of the FDA's Center for Devices and Radiological Health, in an interview, said: “ What we can say is, the current data doesn't indicate that silicone-gel-filled breast implants are linked to breast cancer, connective tissue disease, nor infertility. Research by the two manufacturers of the implants, indicates that we have a reasonable assurance of safety and effectiveness when the implants are used properly”.

The FDA report was also quick to warn consumers not to assume that silicone implants are risk free. “Patients should still get MRIs every two years to screen for "silent ruptures" of the silicone implants, since the silicone implants don't deflate when they break, unlike saline implants”.

COMMENTARY

Lawyers for years have been trying to link silicone leakage with old diseases like rheumatoid arthritis, lupus, and scleroderma. In reality, the implants have caused a new disease some call: “silicon immune toxicity syndrome”.

The FDA research on breast implants before 1986 found 55% of the implants had some ruptures and leakage. The silicon leakage causes free radical production that attack the immune system. The silicone gel breaks down into silicone, and antibodies are produced against the silicone. DNA in the cell walls are damaged, enzyme systems are disrupted, and autoimmunity problems occur. This results in food and chemical sensitivities, joint pains, breathing problems, hair loss, fibromyalgia, and neurological dysfunctions.

The FDA report June 2011 has no mention about their January finding of lymphomas. Both companies enrolled 40,000 women in the studies but lost contact with many of them in a study that was intended to last 10 years. Now after 5 years into the study, Allergen says they have followed 60% of the women for two years, while Mentor followed 21% over three years. Both companies said “we are trying to improve follow-up”. How can you lose 40-80% of your patients from an important FDA mandated follow up clinical study? How can the FDA approve such clinical trial report so deficient.

New deputy director, Maisel, said the agency’s conclusions weren’t dependent on just manufacture studies”. He said they looked at studies that began before 2006 that followed fewer women.”

Interestingly Maisel’s predecessor, Steve Rhodes, an FDA supervisor for breast implants, left March 2010 for a position with “Biologics consulting group”. After 20 years with the FDA, being responsible for reviewing and approving breast implants, he joined the other side. Biologics consultants include former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biopharmaceutical industry.

Will we every learn? Is the FDA protecting you or the medical device industry?

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm
http://www.plastic-surgery.net/dangers-breast-implants.html
http://breastimplantlawyers.com/
 http://www.orthospinenews.com/biologics-consulting-group-inc-announces-stephen-p-rhodes-as-senior-consultant-expands-expertise-in-medical-devices-and-combination-products

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