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FDA Busts Johnson & Johnson and Sientra Over Breast Implant Safety

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The U.S. Food and Drug Administration recently issued warning letters to two major manufacturers of breast implants for failure to meet the agency’s post-approval study requirements.

In its letters, the FDA alleges that J&J and Sientra failed to comply with the agency’s requirements for further scientific study after the implants were originally approved to sell on the market.

The warning letters come on the heels of an FDA warning last month that a breast implants could be related to a particular type of lymphoma. Now, the agency is shining a light on problems with the companies’ post-approval studies that were mandated by the agency. These studies included evaluating breast implants’ long-term safety.

In its letter to J&J, the FDA highlighted several serious problems with the company’s post-approval study, particularly for its breast implant brand MemoryShape, which was approved by the FDA in 2013. The FDA cited deficiencies, including J&J’s poor patient accounting, its failure to enroll the required number of patients in the study, missing data on patient race and ethnicity, and other data inconsistencies.

J&J’s aesthetics unit, Mentor Worldwide LLC, said that it was disappointed to receive the FDA’s letter, particularly when it was in the process of trying to resolve post-approval study issues with the agency. A spokesperson for Mentor said that it had made multiple attempts to discuss the study issues with the FDA, but that the agency had failed to provide feedback.

Similarly, Sientra was also cited in the FDA’s letter as having deficiencies in its post-approval research study. Specifically, the FDA highlighted that Sientra’s patient follow-up rate of 61% was poor and was inadequate to evaluate the long-term safety of its implants. The company was under mandate from the FDA to evaluate its study subjects each year for a total of ten years.

In response to the letters, the FDA is asking both companies to provide written responses within 15 business days that illustrate how each company’s violations will be corrected.  If J&J and Sientra don’t fix the mistakes, though, the agency may revoke the premarket approval for their products.

The safety of breast implants, particularly for long-term use, has been studied and questioned frequently over the years. They are widely used in the U.S. and abroad for aesthetic procedures such as voluntary breast augmentation as well as reconstruction procedures.

But the use of breast implants has been debated between manufacturers, the FDA, and patient advocacy groups for decades. Breast implants have been the reason for numerous complaints, patient health problems and lawsuits. In response to these problems, the FDA imposed a moratorium on breast implants, banning them from the US market from 1992 to 2006. When that ban was lifted in 2006, the FDA required every manufacturer of breast implants to conduct at least six post-approval studies. These studies are intended to assess the effectiveness and safety of each company’s breast implant product, as well as address specific scientific questions about the products’ long-term safety in patients. The FDA said that its post-approval requirements are critical to ensure the safety of medical products like breast implants, as well as their effectiveness. The agency intends to hold manufactures accountable for meeting the study requirements and says will continue to do so until the agency’s post-approval obligations are met. 

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New Approved Treatment Becomes Available for Mesothelioma

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Doctor team examining at lung radiograph x-ray film of patient in operation room.

A new treatment for patients diagnosed with mesothelioma has recently been approved by the FDA and is now available at the West Cancer Center in Memphis, TN. This is the first center in the nation to use electric therapy treatment for these patients.

An Exciting New Treatment

Electric therapy treatment works by sending electric fields into the body to target cancerous cells. The technician applies three pads to the front and back of the patient. Once the unit is turned on, electric fields are sent through the person’s body to disrupt the growth of the cancerous cells. At the same time, it leaves the healthy cells alone.

The new treatment promises to be popular because it’s not invasive. There are few side effects as well. The first patient has received the treatment, and they are wearing it for 18 hours each day. It is expected to have 97 percent control in the first year. If the patient uses the treatment along with chemotherapy, they may have a stable disease or positive response.

The device was first introduced in 2015 to treat brain tumors. It has since been used with ovarian and pancreatic cancer. It’s not being labeled as a cure, but it does help patients live longer. People diagnosed with mesothelioma normally have about two years life expectancy because this is an aggressive cancer. It’s rare, which makes research and treatment difficult.

Before the new treatment was approved, there were three options for treating mesothelioma, which included surgery, chemotherapy and radiation.

What is Mesothelioma?

Mesothelium is the tissue in the lining of your lungs, heart, stomach and other organs. Mesothelioma is a cancer of that tissue. It generally starts in the lungs, but it can begin in other organs as well. This condition has been linked to exposure to asbestos because the asbestos fibers get in the lungs when inhaled where they can’t disappear. Over time with constant exposure, more fibers get into the lungs. Symptoms of this disease often wait 20 or 30 years after exposure to show up. It starts with shortness of breath or pain in the chest. Fluid begins to accumulate, making it even more difficult to breathe.

Anyone who has been exposed to asbestos is at greater risk for developing mesothelioma. Even if you live with someone who works in the industry around asbestos can have an increased risk because they can inhale the fibers from that person’s clothing.

This type of cancer usually isn’t diagnosed until it’s advanced. The doctor will often order an X-ray of the chest or CT scan. If abnormalities are found, a biopsy may be ordered. After it has been analyzed, the results will tell if it is cancerous. Diagnosis could happen much more quickly if the person knows they were exposed to asbestos, but many people don’t think about these details of a job from 20 or 30 years ago.

Mesothelioma patients may find new hope with the treatment if it enhances the quality and quantity of their lives.

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Hernia Mesh Defective Products Cause Lifelong Complications

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Hernia mesh products have been around since the 1950s when they were first developed. They have become widely accepted as a method to repair hernias. Over time, manufacturers have altered these products with new materials, various coatings and unique features. Some of the mesh products have been proven to be defective, even to the point of causing life-changing injuries.

Multiple Defective Products

Even though hernia mesh products have been around for decades, new products are continually being introduced and not all of them are safe. Some of these products contain different materials and have not been tested thoroughly to determine safety. Often, additional surgery is required to remove the mesh and to repair the hernia again that the first mesh failed to treat.

Some of the products involved in lawsuits include the following:

  • Covidien – one of the most recognizable names, Covidien has had numerous claims against its products. Parietex hernia mesh was one product that used the material polyester rather than polypropylene. While it tried to fix the problems associated with this product, it did not test the safety of the mesh before putting it on the market.
  • Bard – another well-known name, Bard has a product called Sepramesh IP Composite, which is supposed to incorporate itself into the tissue and is made with polyglycolic acid and polypropylene. It is used in reconstructing soft tissue loss, but has been associated with serious side effects, including bowel obstruction and adhesions, which often require surgeries to correct.
  • Ethicon – the Ethicon Physiomesh was approved by the Food and Drug Administration (FDA) in April 2010 and launched as a product in October 2010. However, it was taken off the market voluntarily because of issues with the base layer, which is made of polypropylene. This plastic material is coated with polymeric films which is supposed to cause the material to degrade, but it often remains in the person’s body for a long time.
  • Atrium – The Atrium C-QUR was approved for use by the FDA in March 2006, but it has been associated with problems. Two versions, one used for pre-peritoneal repairs and another with placement in the intra-abdominal area, were designed for small hernia issues.

Complications from Hernia Mesh Products

Hernia mesh products can cause a wide range of side effects. The most minor include severe pain, but most require surgery to fix the problem. The most common complications from this product is also the most serious. Adhesion and bowel obstruction are common along with the risk of rejection, migration and infection.

One of the most common complications is adhesion which causes scar-like tissue to stick together and results in chronic pain that may be severe. It can lead to bowel obstruction which can be life-threatening.

In one case, a hernia mesh product attached to the small intestine of a patient. It was necessary to remove the mesh just 12 days after the original surgery to implant it. The mesh products are usually coated to prevent the risk of adhesion, but the coating is dissolved in the body in a short time, which then allows the product to adhere to the intestines or other tissue.

The mesh can also migrate to other areas of the body, where it can cause other issues. One of the most severe and dangerous complications is bowel obstruction. The person begins to feel nauseated and vomits and is unable to pass stool or even gas. Treatment is necessary immediately or the person can die. The obstruction will cut off blood flow if not treated quickly, which will allow part of the intestine to die and need to be removed. According to the FDA, a major reason for bowel obstruction is due to recalled mesh.

Bowel perforation is another serious condition which happens from hernia mesh. It occurs when the product punctures the bowel. The mesh can also perforate other organs or the abdominal wall. Symptoms include nausea and vomiting, severe pain in the abdomen and rigidity. Bacteria gets into the abdominal cavity and leads to peritonitis or sepsis and requires immediate medical attention.

These and other complications may occur right away after the initial surgery. However, it can also be years before a person experiences the complications. With the longer wait, it can take some time to realize the direct cause is the hernia mesh. Lawsuits have been filed for hernia mesh complications that resulted from recalled products or those that have been deemed to be defective. The cost of repair can be quite a financial burden with multiple surgeries and even permanent damage.

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Complications from Hernia Mesh

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hernia mesh

Hernia mesh products have been around and used in hernia repair surgeries since they were first introduced in the 1950s. However, they have not been without some serious complications, which can even be life-threatening. While there are risks for any hernia repair surgery, some of the most common and most serious have resulted from mesh products that have been recalled.

Adhesion from Hernia Mesh Products

One of the most common issues is adhesion from the mesh implanted in the abdomen of the patient. Hernia mesh products are made of a variety of materials, and they may attach to tissue inside. The mesh has a coating which helps prevent the issue, but the coating dissolves while the mesh is often permanent.

The mesh may adhere to the abdominal wall or the intestines or other tissue. It can cause severe pain that won’t go away until the product is removed through surgery. Adhesion can lead to bowel obstruction.

Bowel Obstruction with Hernia Mesh

A bowel obstruction begins with an adhesion to the intestines. It can also migrate where it can entrap the intestines. Symptoms of bowel obstruction include nausea and vomiting. The patient is also unable to pass stool. They will require immediate attention because this is a dangerous condition.

If not treated quickly enough, part of the intestine may need to be removed. Reports from the FDA cite mesh products that have been recalled as a major reason for obstruction.

How Hernia Mesh Causes Bowel Perforation

Recalled products have also been shown to cause perforation in the bowels. This occurs when the mesh punctures the intestine or other area of the abdomen. It may also puncture an organ, creating a life-threatening condition.

Symptoms of a bowel perforation include nausea and vomiting along with severe pain in the abdomen and rigidity of the abdomen – the abdomen feels hard. Bacteria can get into the abdomen from the puncture, which can then lead to sepsis and peritonitis. These conditions may be fatal.

Infection from Hernia Mesh

An infection may result from hernia mesh surgery. Often, the mesh will need to be removed through surgery. Antibiotics can treat minor issues while deep infections are more complicated. Chronic infection may not begin for years after the initial surgery, which can make it more difficult to diagnose.

A person with infection from a hernia mesh product may experience inflammation and fever. They may notice other flu-like symptoms as well.

Migration of the Hernia Mesh

Another complication for hernia mesh surgery is that the product will detach and migrate into other areas of the body. Complications from a migrating mesh can include the following:

  • Adhesion
  • Bowel obstruction
  • Bowel perforation
  • Abscess
  • Fistulas

In one case reported to the FDA, an implant detached and migrated to the intestine where it adhered. Surgery was required to remove the mesh along with a portion of the intestine.

There may be pain with migration or the patient may not have any symptoms until other damage occurs.

Damaged Mesh

The hernia mesh product may rip, tear or disintegrate, causing problems. The mesh can rip from the sutures, which often happens if the person lifts something too heavy or overexerts themselves too soon after surgery.

Another issue is if the mesh shrinks, which can cause it to come lose from the sutures in time. A long-term issue is when the mesh erodes and breaks into pieces. The pieces may move around and perforate surrounding tissue.

All of these problems can lead to migration, which can cause other complications. Surgery is often necessary to repair the condition.

Issues with hernia mesh can happen right after surgery, a few weeks or months later or years afterwards. The hernia may rupture again even with the mesh in place. While the product is effective at repairing the hernia, it is not a guarantee.

Defective Products

As with any surgical procedure, there is a risk of these complications even if everything is done correctly. However, there have been numerous recalls of hernia mesh products that increase the risk of problems. It may be related to the materials used or the design of the product. Some products have a higher failure rate than others, and some have been recalled due to their safety issues.

It is important to let a doctor know you’ve had a hernia mesh if you experience symptoms that can be associated with these complications. Often, immediate medical attention is necessary to prevent further damage or health issues. It can be difficult to diagnose a condition related to the mesh correctly.

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