Drug Safety Developments

Textured Breast Implants Ban: Will the FDA Reevaluate?

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

As we have continuously discussed here, textured breast implants are being banned in some countries not including the U.S. You can refer to our most recent previous article on the topic, “U.S. FDA Refrains from Textured Implants Ban”, to explore what has happened thus far worldwide as regards banning textured breast implants due to the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

 

The FDA’s Reasoning

It is our understanding that the FDA is choosing to not ban textured breast implants in the U.S. due to the lack of a strong causal relationship between this particular type of implant and BIA-ALCL.

In March of this year, the FDA sent out warning letters to both Allergan and Mentor because they did not conduct the necessary post-approval study requirements. An April 2019 article of ours, “March 2019 FDA Meeting on Breast Implants: A Summary Of What You Need To Know”, can provide you with the information contained in the warning letters and details about the post-approval studies.

 

Statements from the Manufacturers

Healio just published an article, “FDA weighs breast implant risks, benefits amid links to cancer, other illnesses”, which includes statements from representatives of both Allergan and Mentor defending their companies’ products.

Both vice presidents from Allergan and Mentor / Johnson & Johnson have expressed similar thoughts about their companies' products in response to the FDA's warning letters. Essentially, they both vouch that their breast implants are monitored and supported by large and long-term clinical studies. In response to the warning about their memory shape implants, Raina Dauria of Mentor / Johnson & Johnson adds:

The use of textured devices in the U.S. has decreased substantially, and Mentor has been challenged in enrolling this study group, despite taking steps to increase enrollment.

As regards the general discussion of potential risk of BIA-ALCL, Stephanie Manson Brown, MD, of Allergan shares: 

Patients with BIA-ALCL can have an excellent prognosis when identified early and treated appropriately... the leading hypothesis centers around biofilm and there are three likely factors that contribute to this, including procedure, product and patient.

This May 2019 Helio article also discusses the onset of symptoms of BIA-ALCL, from the perspective of The University of Texas MD Anderson Cancer Center, with delayed seroma as apparently being the most prominent symptom. Mark Clemens, MD, notes the association between specific brands of implants and the risk of BIA-ALCL. That risk is apparently 7.1 to 8.3 times higher with Allergan Biocell implants compared to all other manufacturers combined.

Canada in Contrast

Allergan may have only received a warning letter in the U.S., but in Canada its sales are being put to a halt. Two days ago Canada’s government website published the article, “Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer”, which informs that Health Canada has determined a much higher risk of BIA-ALCL in relation to macro-textured implants, this being 85% of the 26 confirmed cases in Canada. As a result, they have suspended the sale and import of Allergan’s Biocell breast implants and Allergan is voluntarily recalling such unused implants.

An article from Reuters published on the same day, “Allergan to recall textured breast implants in Canada” delivers this quote:

Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.

With such a strong conclusion from Health Canada regarding the risk of BIA-ALCL from textured implants and the hundreds of women who have been diagnosed, even some deaths occurring, we should wonder... is the FDA going to change its mind?

 

We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic of breast implants and BIA-ALCL.

U.S. FDA Refrains from Textured Implants Ban

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

In our most recent article on breast implants and their link to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), “Textured Breast Implants Bans on the Rise” we left off wondering whether or not the U.S. was going to follow in the footsteps of Canada and France as regards banning textured implants.

 

No Ban in the U.S.- Why?

As of early May, we can now confirm that the U.S. will not be part of the ban at the current time.

The New York Times provided us with an article on May 2, 2019, “F.D.A. Won’t Ban Sales of Textured Breast Implants Linked to Cancer” which informs us that while most BIA-ALCL cases have occurred in relation to textured implants, the risk and data is still too low to prompt a ban. Smooth implants cannot be disregarded as a potential cause for the rare lymphoma.

This may have you questioning whether or not a ban on textured implants should occur, since the potential risks have been made well-known and other countries have already banned them. This May 2019 New York Times article educates us that, “Only about 10 percent of the implants used in the United States are textured, but in other countries the figure can be as high as 80 percent” 

Additionally, on May 3, 2019, The Washington Post published an article, “FDA won’t ban breast implants linked to cancer at this time” which shared information similar to the article from The New York Times, but gives some additional insight:

The FDA does not believe the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Measures to be Taken Rather than a Ban

An NBC news article from May 3, 2019, “FDA will not ban textured breast implants at this time” tells us that the FDA plans to make label changes and requirements for reporting incidents:

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning - the FDA’s strictest caution. Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

The May 2019 Washington Post article reiterates the possibility of the black-box warning to come and adds that the FDA “may require doctors and patients to sign risk checklists to make sure patients have the necessary information to make an informed decision.”

In furtherance, the FDA is going to require individual medical device reports to be filed by the manufacturing companies if any problems occur with the breast implants. This will ensure that the presence of these breast implant problems is made more available to the public.

 

Even without an FDA ban, it seems like women may steer away from textured implants altogether now because of the associated risks. Rest assured that we will continue to monitor the situation of textured breast implants and report any new information as regards the FDA's plan considering there will be no ban. You can visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic.

MiraLAX: Official Science Effort Regresses while the Public's Investigation Progresses

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Recent Communication with the FDA and CHOP

If you have kept up with our previous articles on MiraLAX, or follow the issue in general, you may have noted the ongoing delay in the Children's Hospital of Philadelphia (CHOP) PEG 3350 study and the lack of information from both CHOP and the FDA on the matter. Refer to our earlier article, “Efforts to Advance MiraLAX Studies and Innovations to Inform the Population”, to grab some details of the study.

Now it appears the same problem is occurring. Those who advocate for and investigate the MiraLAX issue have been in communication with CHOP and the FDA, urging both to provide some sort of an answer as to what is going on with the CHOP study. Ultimately, why children still are not even enrolled when the study was supposed to be completed in 2018.

The FDA’s press has said, “assays required to analyze the data that will be gathered raise novel scientific issues and will be challenging to develop...the FDA is providing additional assistance with this... we have asked CHOP to give more frequent updates”

Meanwhile, a representative from CHOP has said they are, “actively working with the FDA to finalize methods of this study and an announcement will be made once we start enrolling patients”

 

FAERS and OpenFDA Inconsistencies

It has come to our attention that running MiraLAX and polyethylene glycol (PEG) 3350 on the FDA Adverse Event Reporting System (FAERS) and OpenFDA gives very different results. FAERS shows the total cases for MiraLAX at 24,413 and PEG 3350 at 26,924. On the other hand, OpenFDA shows the total reports in its database for MiraLAX at 43,340 and PEG 3350 at 64,125.

This huge data discrepancy was sent to the Center for Drug Evaluation and Research as an inquiry. The response was that, “All data in FAERS public dashboard is based on FAERS data. We are not familiar with the source for OpenFDA reports. FAERS public dashboard shows ONLY suspects [sic] drugs. That could be one of the reasons for the discrepancy since OpenFDA could show both suspect and concomitant [drugs].”

 

Film for Thought

An upcoming film, "My Kid is Not Crazy", takes an interesting perspective on the issue of neuro-psychiatric problems in young children.

Dr. Susan Swedo with the National Institute of Health dedicated her time to researching, understanding, and finding the cure for the condition she calls “Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)” You can visit the film’s website to learn more about what PANDAS is.

It appears the main takeaway that the audience will get from this film is that children who develop the symptoms of PANDAS may often be diagnosed with a mental illness. As a result, they may be given medications or other treatments to combat their “neuropsychiatric issue”. Doctors are quick to settle on such a diagnosis and pharmaceutical companies are happy to make money off of the medications.

To understand how this film relates to the MiraLAX issue, you can read the May 2017 article of ours, “Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX”. Both PANDAS and MiraLAX present the same sort of issue in the behavior of young children.

 

We will continue to monitor the MiraLAX issue, including new developments and study updates. As always, we are open to any relevant information parents and medical researchers may have and intend to keep the public as informed as we are. 

 

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